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PULSE: A Randomized, Phase II Open Label Study of PanitUmumab RechaLlenge Versus Standard Therapy After Progression on Anti-EGFR Therapy in Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer (PULSE)

Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer

Zhaohui Jin
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-107380-P01-RST
19-010836
Show full eligibility criteria
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Inclusion Criteria:


- Registered to Colorectal Cancer Liquid Biopsy Screening Protocol for Molecularly
Assigned Therapy (COLOMATE) ACCRU-GI-1611 and:

- COLOMATE Companion Trial Recommendation Form indicates patient qualifies to be
screened for a COLOMATE companion trial.

- COLOMATE Companion Trial Recommendation Form date of completion is =< 30 days
prior to randomization.

- Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum
that is metastatic and/ or unresectable.

- Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in
BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to
receipt of anti EGFR therapy.

- Progression, intolerance, or contraindication to a fluoropyrimidine (e.g.,
5-fluorouracil or capecitabine), oxaliplatin, irinotecan, and an anti-VEGF monoclonal
antibody (bevacizumab, ramucirumab, or aflibercept), and an anti-PD-1 monoclonal
antibody (nivolumab or pembrolizumab) if tumor has deficient mismatch repair proteins
(dMMR) or is microsatellite instability-high (MSI-H)

- Disease progression after treatment with an anti-EGFR monoclonal antibody (cetuximab
and/or panitumumab) for at least 4 months (minimum of 8 biweekly treatments or 16
weekly treatments at full or partial dose).

- NOTE: Treatments do not need to be administered consecutively.

- NOTE: Dose reductions or delays are permitted.

- Greater than 90 days has elapsed between the most recent treatment with an anti-EGFR
therapy (cetuximab or panitumumab) and blood collection for COLOMATE ACCRU-GI-1611.

- At least one site of disease that is measurable by Response Evaluation Criteria in
Solid Tumors (RECIST) criteria that has not been previously irradiated; if the patient
has had previous radiation to the target lesion(s), there must be evidence of
progression since the radiation.

- Life expectancy >= 3 months per estimation of investigator.

- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.

- Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
(obtained =< 7 days prior to randomization).

- Platelet count >= 75,000 /mm^3 (obtained =< 7 days prior to randomization).

- Hemoglobin > 8.0 g/dL (obtained =< 7 days prior to randomization).

- Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to
randomization).

- Aspartate transaminase (AST) =< 2.5 x ULN (=< 5 x ULN for subjects with liver
involvement of their cancer) (obtained =< 7 days prior to randomization).

- Alanine aminotransferase (ALT) =< 2.5 x ULN (=< 5 x ULN for subjects with liver
involvement of their cancer) (obtained =< 7 days prior to randomization).

- Calculated creatinine clearance must be > 30 ml/min using the Cockcroft-Gault formula
(obtained =< 7 days prior to randomization).

- Women of child bearing potential and male partners of women of child bearing potential
must agree to use two medically accepted methods of contraception, one of them being a
barrier method during the study and for 2 months after the last dose of study drug(s).

- Negative serum pregnancy test done =< 7 days prior to randomization, for women of
childbearing potential only.

- NOTE: Women of childbearing potential include women who have experienced menarche
and who have not undergone successful surgical sterilization (hysterectomy,
bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal.
Postmenopause is defined as amenorrhea >= 12 consecutive months. NOTE: women who
have been amenorrheic for 12 or more months are still considered to be of
childbearing potential if the amenorrhea is possibly due to prior chemotherapy,
anti-estrogens, ovarian suppression or any other reversible treatment.

- Ability to complete questionnaire(s) by themselves or with assistance.

- Capable of understanding and complying with the protocol requirements and has signed
the informed consent document.

- Willing to return to enrolling institution for follow-up (during the active monitoring
phase of the study).

- Willing to provide tissue and blood samples for correlative research purposes.

- Willing to allow transfer of tissue and blood samples, clinical information, and
outcome data collected from this trial for future research.


Exclusion Criteria:


- Radiation therapy, hormonal therapy, biologic therapy, experimental therapy, or
chemotherapy for cancer < 21 days prior to randomization.

- Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin).

- Maximum mutant allele frequency (highest allele frequency reported for any gene
mutation) (MAF) less than 2% by Guardant360 assay.

- Detection of at least one of the following gene mutation(s) or amplification(s) by
Guardant360 assay.

- BRAF mutation mutant allele frequency (MAF) > 0.5%.

- EGFR mutation (MAF > 0.5%). Note: EGFR S492R, K467, and R451C mutations are not
an exclusion.

- ERBB2 (HER2) mutation (MAF > 0.5%) or amplification.

- KRAS mutation (MAF > 0.5%) or amplification.

- MET mutation (MAF > 0.5%) or amplification.

- NRAS mutation (MAF > 0.5%) or amplification

- Prior treatment with both TAS-102 and regorafenib (prior treatment with either TAS-102
or regorafenib is permitted).

- Unable to swallow oral tablets (crushing of study treatment tablets is not allowed).

- Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment
of the investigator, would make the patient inappropriate for entry into this study or
interfere significantly with the proper assessment of safety and toxicity of the
prescribed regimens. Note: This includes impaired heart function or clinically
significant heart disease.

- Not recovered to baseline or Common Terminology for Adverse Events (CTCAE) version
(v)5.0 =< grade 1 from toxicity due to all prior therapies except alopecia,
oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities, and other
non-clinically significant adverse events.

- Any of the following because this study involves an agent that has known genotoxic,
mutagenic and teratogenic effects:

- Pregnant women.

- Nursing women.

- Men or women of childbearing potential who are unwilling to employ adequate
contraception.

- Patients with known central nervous system (CNS) metastases. Note: Patients with
radiated or resected lesions are permitted, provided the lesions are fully treated and
inactive (based on repeat imaging >= 30 days after completion of definitive
treatment), patients are asymptomatic, and no steroids to control symptoms related to
CNS metastases have been administered for at least 30 days.

- Major surgical procedure, open biopsy, or significant traumatic injury =< 28 days
prior to randomization (=< 56 days for hepatectomy, open thoracotomy, major
neurosurgery) or anticipation of need for major surgical procedure during the course
of the study.

- Serious, non-healing wound, ulcer, or bone fracture.

- History of stroke (cerebrovascular accident), transient ischemic attack (TIA),
myocardial infarction (MI), unstable angina, cardiac or other vascular stenting,
angioplasty, or cardiac surgery =< 6 months prior to randomization.

- History of cardiac arrhythmias requiring anti-arrhythmic therapy other than beta
blockers, calcium channel blockers, or digoxin =< 6 months prior to randomization.

- Known history of congestive heart failure
•New York Heart Association (NYHA) >= class
II.

- Known history of human immunodeficiency virus (HIV) seropositivity, acute or chronic
active hepatitis B or C infection, or other serious chronic infection requiring
ongoing treatment.

- History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest computed tomography (CT) scan.

- Subjects with any previously untreated or concurrent cancer that is distinct in
primary site or histology from colorectal cancer except cervical cancer in-situ,
treated basal cell carcinoma, or superficial bladder tumor. Note: Subjects surviving a
cancer that was curatively treated and without evidence of disease or biochemical
relapse (undetectable PSA for prostate cancer) for 3 or more years before
randomization are allowed. All cancer treatments must be completed at least 3 years
prior to randomization.

- Uncontrolled hypertension (systolic pressure > 150 mm HG or diastolic pressure > 90 mm
Hg [National Cancer Institute (NCI)-CTCAE v5.0]) on repeated measurement despite
optimal medical management.

- Evidence or history of bleeding diathesis or coagulopathy.

- Any hemorrhage or bleeding event >= NCI CTCAE v5.0 grade 3, =< 4 weeks prior to
randomization.

- Ongoing active infection > grade 2 NCI-CTCAE v5.0.

- Known or suspected allergy or hypersensitivity to any of the study drugs, study drug
classes, or excipients of the formulation given during the course of this trial.

- EXCEPTION: Cetuximab

- Any known history of malabsorption condition.

- Substance abuse, medical, psychological or social conditions that may interfere with
the subject's participation in the study or evaluation of the study results.

- Use of any herbal remedy (e.g. St. John's wort) =< 7 days prior to randomization.

- Use of strong CYP3A4 inducers or inhibitors =< 7 days prior to randomization.

Eligibility last updated 5/25/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other, Behavioral
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Mayo Clinic — Rochester, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Amrit Singh
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-MAIJ
19-000587
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic Health System — Mankato, MN

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (≥ 65 Years of Age) With Chronic Lymphocytic Leukemia (CLL)

A Study to Evaluate Ibrutinib and Obinutuzumab With or Without Venetoclax in Treating Older Patients With Untreated Chronic Lymphocytic Leukemia

Wei Ding
All
65 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100026-P01-RST
19-000587
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0)

  • Patients must have been diagnosed with CLL and have > 5000 B-cells per uL of peripheral blood at any point during the course of their disease.
  • This blood submission is mandatory prior to registration/randomization to perform FISH centrally that will be used for stratification. It should be obtained as soon after preregistration as possible.

REGISTRATION ELIGIBILITY CRITERIA (STEP 1) 

  • Patients must be diagnosed with CLL in accordance with 2018 IWCLL criteria [28] that includes all of the following:
    • ≥ 5 x10^9 B lymphocytes (5000/μL) in the peripheral blood measured by flow cytometry at any point in the course of the disease;
    • On local morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed 55% of the blood lymphocytes;
    • CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of CD19 and CD20, as well as the T-cell antigen CD5. Patients with bright surface immunoglobulin expression or lack of CD23 expression in >10% of cells must lack t(11;14) translocation by interphase cytogenetics.
  • Patients must be intermediate or high-risk Rai stage CLL.
    • Intermediate risk (formerly Rai stage I/II) is defined by lymphocytosis plus any of the following: enlarged lymph nodes, hepatomegaly, or splenomegaly'
    • High risk (formerly Rai stage III/IV) is defined by lymphocytosis with or without enlarged nodes and spleen plus disease-related anemia (hemoglobin < 11 g/dL) or thrombocytopenia (platelet count < 100 x 10^9/L) that is not attributable to autoimmune hemolytic anemia or thrombocytopenia.
  • Patients must meet criteria for treatment as defined by 2018 IWCLL guidelines which includes at least one of the following criteria:
    • Evidence of marrow failure as manifested by the development or worsening of anemia or thrombocytopenia (not attributable to autoimmune hemolytic anemia or thrombocytopenia);
    • Massive (≥ 6 cm below the costal margin), progressive or symptomatic splenomegaly;
    • Massive nodes (≥ 10 cm) or progressive or symptomatic lymphadenopathy;
    • Progressive lymphocytosis with a lymphocyte doubling time < 6 months or an increase of ≥ 50% over a 2 month period;
    • Autoimmune anemia and/or thrombocytopenia that is poorly responsive to standard therapy;
    • Symptomatic or functional extranodal involvement (e.g., skin, kidney, lung, spine);
    • Constitutional symptoms, which include any of the following:
      • Unintentional weight loss of 10% or more within 6 months;
      • Significant fatigue;
      • Fevers >100.5 degrees F for 2 weeks or more without evidence of infection;
      • Night sweats ≥1 month without evidence of infection.
  • Patients must not have had prior therapy for CLL (except palliative steroids or treatment of autoimmune complications of CLL with rituximab or steroids).
  • Treatment with rituximab and/or high dose corticosteroids for autoimmune complications of CLL must be complete at least 4 weeks prior to enrollment. Palliative steroids must be at a dose not higher than 20 mg/day of prednisone or equivalent corticosteroid at the time of registration.
  • Age ≥ 65 years.
  • ECOG performance status 0-2.
  • Required initial laboratory values.
  • Absolute Neutrophil Count (ANC) ≥ 1,000/mm^3 except if due to bone marrow involvement.
  • Platelet Count (untransfused) ≥ 30,000/mm^3.
  • Calc. Creatinine Clearance ≥ 40 mL/min (by Cockcroft-Gault).
  • Bilirubin ≤ 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert’s disease.
  • AST / ALT ≤ 2.5 x upper limit of normal (ULN) except if due to liver involvement.
  • Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%).
  • If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician.
  • If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
  • Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
  • Patients who have had a myocardial infarction, intracranial bleed, or stroke within the past 6 months are not eligible.
  • Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not allowed on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study. 
  • Chronic concomitant treatment with strong CYP3A4/5 inducers is not allowed.
  • Patients must discontinue the drug 14 days prior to registration on the study.
  • Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
  • Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics.
  • Central FISH blood results are mandatory prior to registration/randomization for it will be used for stratification.
  • Patients must be able to swallow capsules and not have the following conditions:  disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel obstruction.
  • Patients must not have a known allergy to mannitol.
  • Patients must not have prior significant hypersensitivity to rituximab (not including infusion reactions).
  • Patients may not have had major surgery within 10 days prior to registration, or minor surgery within 7 days prior to registration. Examples of minor surgery include dental surgery, insertion of a venous access device, skin biopsy, or aspiration for a joint. The decision about whether a surgery is major or minor can be made at the discretion of the treating physician.
  • Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase for prophylaxis/treatment of TLS.

RE-REGISTRATION ELIGIBILITY CRITERIA (STEP 2)

  • Completion of treatment through Cycle 14 Day 28, and remain on ibrutinib therapy.
  • Receipt of central BM MRD results.
  • Response assessment completed per Section 5.0 with CR determination.

Eligibility last updated 1/17/22. Questions regarding updates should be directed to the study team contact.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia
4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Afutuzumab, Biological therapy for cancer, Cancer treatment, Chemotherapy, Chronic lymphoid leukemia, disease, Hematopoietic system, Ibrutinib [USAN:INN], Medical Oncology, Targeted drug therapy, ibrutinib, obinutuzumab, venetoclax
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Mayo Clinic — Rochester, MN

MC1974: A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Of Unknown Primaries (HNCUP)

A Study to Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer

Daniel Ma
All
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101161-P01-RST
19-012222
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Patients meet criteria for IMPT treatment for Oropharyngeal Cancer as outlined in the procedure manual.
  • If IMPT is declined by patient’s insurance, they can be treated with standard of care IMRT using the same applicable standard of care procedures outlined in the procedures manual.
  • Meet criteria for adjuvant chemotherapy (if applicable).
  • Histological confirmation of HPV+ squamous cell carcinoma as defined by neck node pathology. HPV positivity will be defined as positive staining for p16 and HPV DNA ISH. (If discordant, RNA ISH will be run for confirmatory testing).
  • Clinical stage T0 N1-N3 and confirmed Pathologic stage T0 N1-N2 M0 (AJCC 8th edition) with one of the following risk factors:
    • lymph node ≥ 3cm;
    • ≥ positive lymph nodes;
    • presence of extracapsular extension;
    • > 1 nodal level involved.
  • Absence of distant metastases on standard diagnostic workup, prior to registration (Chest CT, CXR, or PET/CT).
  • Able to undergo pre-operative Q-clear series PET/CT head/neck for diagnostic workup of occult primary and nodal disease.
  • Able to undergo Transoral Surgery and neck dissection by their ENT oncologist.
  • Surgical exploration/sampling of all mucosal sites including ipsilateral wide field tonsillectomy and base of tongue resection.  Additional biopsies or surgical excision at the surgeon’s discretion. Any radiographic or clinically suspicious areas should be biopsied or removed. Bilateral neck dissection for high risk patients. Ipsilateral dissection only, for patients with contralateral cN0 necks and negative preoperative imaging.
  • Final pathologic evaluation demonstrating all benign samplings without discernible primary.
  • Documented smoking history.
  • ECOG Performance Status (PS) 0 or 1. 
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Following laboratory values obtained ≤ 35 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥100,000/mm^3;
    • Hemoglobin  ≥8.0g/dL;
    • Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min;
    • Total or direct bilirubin < 2 x institutional upper limit of normal (ULN);
    • AST (SGOT) or ALT (SGPT) < 3 x institutional ULN.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Able to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

 


Exclusion Criteria:

 

  • Any patient with positive retropharyngeal nodes on imaging.
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Other active malignancy ≤ 5 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix.
    • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Immunocompromised patients and patients known to be HIV positive.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • History of connective tissue disorders such as scleroderma, rheumatoid arthritis, lupus, or Sjogren’s disease.
  • Prior history of radiation therapy to the affected site.
Radiation
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Mayo Clinic — Rochester, MN

(ECTx) TG4050.01; A phase I trial evaluating a mutanome-directed immunotherapy in patients with high grade serous carcinoma (HGSC) of the ovary, fallopian tube or peritoneum who experience an asymptomatic relapse

A Study to Evaluate TG4050 in Ovarian Carcinoma

Matthew Block
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101028-P01-RST
19-005397
Show full eligibility criteria
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Inclusion Criteria:
 

Screening Period

  • Signed written informed consent in accordance to ICH-GCP and national/local regulation before any protocol-related procedures that are not part of normal patient care.
  • Female patients ≥ 18 years of age.
  • Histologically confirmed high grade, stage IIIC or stage IV (FIGO staging) serous ovarian, fallopian or primary peritoneal carcinoma with abnormal CA-125 at diagnosis.
  • Patients who have undergone primary debulking surgery or interval debulking surgery and completed a total of at least 5 cycles of taxane-platinum combination.
    • Note: patients may have received concurrent or maintenance bevacizumab or a PARP inhibitor.
  • Patients must have achieved a complete response to therapy, as demonstrated by no residual disease on most recent CT scan and normal CA-125 not increasing by both the following: > 25% from nadir AND ≥ 10 UI/mL from nadir.
  • Patient who remains disease free at least 6 months from last prior dose of cytotoxic chemotherapy (maintenance therapy with bevacizumab or a PARP inhibitor is allowed).
  • Available tumor tissue, banked from previous abdominal debulking surgery and/or from a core needle biopsy performed at diagnosis if the patient received neoadjuvant chemotherapy, and peripheral blood samples for exome and transcriptome sequencing.

Treatment Period

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation.
  • Patients who have developed an asymptomatic relapse as defined by:
    • Cohort A: CA-125 ≥ 2 times ULN on 2 occasions at least 1 week apart (GCIG criteria) or low volume radiological disease and CA-125 > ULN. Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic or splenic metastases, ascites or pleural effusion thought to require drainage;
    • Cohort B: patient asymptomatic with measurable disease, excluding intra-hepatic or splenic metastases, ascites or pleural effusion thought to require drainage, whatever serum CA-125 level and for whom further treatment is not planned within 2 months.
    • Longest diameter on CT-scan must not exceed 2 cm for non-nodal lesions and 2.5 cm in short axis for nodal lesions.
  • Adequate hematological, hepatic and renal functions:
    • Hemoglobin ≥ 9.0 g/dL;
    • Neutrophils count ≥ 1.5 x10^9 /L;
    • Lymphocytes count ≥ 0.9 x10^9 /L;
    • Platelets count ≥ 100 x10^9 /L;
    • Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert’s syndrome);
    • Aspartate aminotransferase (AST) ≤ 2.5 x ULN;
    • Calculated creatinine clearance ≤ 45 mL/min using the Cockroft & Gault formula or ≥ 45 mL/min/1.73m² using other methods.
  • Patients who received standard maintenance therapy will stop before initiation of TG4050 administration. A free-interval of at least 30 days will be respected before first dosing of TG4050 except for PARP inhibitor (at least 14 days).


Exclusion Criteria:
 

Screening Period

  • Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA-4.
  • Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma and recent early stage papillary thyroid cancer. If there is an history of prior malignancy, patient must not be receiving other specific treatment for their cancer.
  • Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. History of blood transfusion within 3 weeks prior to study entry visit.
  • Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
  • Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
  • Positive serology for Hepatis C Virus (HCV) or positive serum Hepatitis B surface antigen (HBsAg) within 3 months prior to or at study entry (tests required).

Treatment Period

  • Measurable disease associated with the appearance of symptoms justifying initiation of further treatment.
  • Major surgery within 4 weeks prior to treatment start.
  • Treatment with another investigational agent within 30 days prior to TG4050 treatment initiation.
  • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to TG4050 treatment initiation planned date, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
  • Vaccination for the prevention of infectious diseases with a live vaccine during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
  • Patient with any underlying medical condition, that in the opinion of the investigator, could make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety or toxicity of the study treatment.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social circumstances that could limit compliance with study requirements.
  • History of myocardial infarction ≤ 6 months.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer
Biological therapy for cancer, Cancer treatment, Extraovarian primary peritoneal carcinoma, Genetic mutation, Malignant tumor of fallopian tube, Malignant tumor of ovary, Medical Oncology, Primary adenocarcinoma of fallopian tube, Primary high grade serous adenocarcinoma of ovary, Reproductive system
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A Phase 1, Open-Label Study To Evaluate the Safety, Tolerability, and Activity of Escalating Doses of AK002 in Patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE)

A Study to Evaluate the Safety, Tolerability, and Activity of Escalating Doses of AK002 in Patients with Eosinophilic Gastritis (EG) and/or Eosinophilic Gastroenteritis (EGE)

Joseph Murray
All
18 years to 80 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122238-P01-RST
19-005392
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Inclusion Criteria:

 

  • Provide written informed consent.
  • Male or female aged ≥ 18 and ≤ 80 years at the time of signing consent.
  • Average weekly score of ≥ 3 recorded for either abdominal pain, diarrhea, and/or nausea on the PRO questionnaire during at least 2 of the last 3 weeks of PRO collection during the Screening period. A minimum of 4 questionnaires must be completed each qualifying week.
  • Eosinophilia of the gastric mucosa ≥ 30 eosinophils/HPF in 5 HPFs and/or eosinophilia of the duodenal mucosa ≥ 30 eosinophils/HPF in 3 HPFs from the EGD performed during the screening period, without any other cause for the gastric eosinophilia (e.g., parasitic or other infection or malignancy).
  • Subjects must have failed or not be adequately controlled on standard of care treatments for EG and/or EGE symptoms (including but not limited to PPIs, systemic or topical corticosteroids, and/or diet).
  • If on allowed treatments for EG and/or EGE at the time of enrollment, stable dose for at least 5 half-lives prior to screening and willingness to continue on that dose for the duration of the study.
  • If patient is on pre-existing dietary restrictions, willingness to maintain dietary restrictions throughout the study, as much as possible.
  • Able and willing to comply with all study procedures.
  • Female subjects must be either post-menopausal for at least 1 year with FSH level >40 mIU/mL at screening or surgically sterile (tubal ligation, hysterectomy, or bilateral oophorectomy) for at least 3 months, or if of childbearing potential, have a negative pregnancy test and agree to use dual methods of contraception, or abstain from sexual activity from screening until the end of the study, or for 120 days following the last dose of study drug, whichever is longer.
  • Male subjects with female partners of childbearing potential must agree to use a highly effective method of contraception from screening until the end of the study or for 120 days following the last dose of study drug, whichever is longer. All fertile men with female partners of childbearing potential should be instructed to contact the Investigator immediately if they suspect their partner might be pregnant at any time during study participation.


Exclusion Criteria:

 

  • Known hypersensitivity to any constituent of the study drug.
  • Previous exposure to AK002.
  • Diagnosis of celiac disease or active H. pylori infection as determined by screening EGD or a history of celiac disease diagnosed by prior EGD.
  • Diagnosis of Hypereosinophilic Syndrome (HES), based on standard criteria (blood eosinophils > 1500/μL with involvement of either the heart, nervous system, and/or bone marrow).
  • Presence of abnormal laboratory values considered by the Investigator to be clinically significant.
  • Grade 2 or higher lymphopenia (< 0.8 × 109/L lymphocytes).
  • Any disease, condition (medical or surgical), or cardiac abnormality, which, in the opinion of the Investigator, would place the subject at increased risk.
  • History of malignancy, exempting carcinoma in situ, early stage prostate cancer, non-melanoma skin cancers, and cancers in remission for >5 years and considered cured (except for breast cancer). All history of malignancy (including diagnosis, dates, and compliance with cancer screening recommendations) must be documented and certified by the Investigator, along with the statement that in their clinical judgment the tissue eosinophilia is attributable to EGID, rather than recurrence of malignancy.
  • Treatment with chemotherapy or radiotherapy in the preceding 6 months.
  • Treatment for a clinically significant helminthic parasitic infection within 6 months of screening and/or a positive helminthic test at screening.
  • Use of any medications that may interfere with the study such as immunosuppressive or immuno-modulatory drugs (including azathioprine, 6-mercaptopurine, methotrexate, cyclosporine, tacrolimus, anti-TNF, anti-IL-5, anti-IL-5 receptor, dupilumab, anti-IgE antibodies, omalizumab) or systemic corticosteroids with a daily dose >10 mg of prednisone or equivalent, during 5 half-lives prior to screening or during the screening period, except for omalizumab taken for asthma and/or urticaria when their asthma and/or urticaria cannot be controlled on other medications, If on omalizumab, the dose must have been stable for at least 4 weeks prior to screening.
  • Vaccination with live attenuated vaccines within 30 days prior to initiation of treatment in the study, during the treatment period, or vaccination expected within 5 half-lives of the study drug administration.
  • Known history of alcohol, drug, or other substance abuse or dependence.
  • Participation in a concurrent interventional study with the last intervention occurring within 30 days prior to administration of study drug (or 90 days or 5 half-lives, whichever is longer, for biologic products).
Drug, Drug therapy
Eosinophilic gastroenteritis, Gastritis, Gastroenteritis, Viral gastroenteritis
Digestive system, Eosinophilic gastritis, Eosinophilic gastroenteritis
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Cognitive Function in Patients with Macular Degeneration and Glaucoma

A Study of Cognitive Function in Patients with Macular Degeneration and Glaucoma

Cheryl Khanna
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122199-H01-RST
19-005034
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Inclusion Criteria:

  • Adults, age > 18 years old.
  • Subjects with wet and dry macular degeneration.
     
  • Note:  Patients with all levels of cognitive ability will be enrolled.


Exclusion Criteria:
 

  • Patients who do not speak English.
Cognitive impairment, Dry macular degeneration, Mild cognitive impairment, Retinal disease, Wet macular degeneration
Exudative age-related macular degeneration, Impaired cognition, Mild cognitive disorder, Nervous system, Nonexudative age-related macular degeneration
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Development and Validation of a Kidney Transplant-Specific Supplement for the Patient Experience with Treatment and Self- Management (PETS) Survey

A Study to Develop and Validate a Kidney Transplant-Specific Supplement Survey for the Patient Experience with Treatment and Self- Management

Andrew Bentall
All
18 years and over
This study is NOT accepting healthy volunteers
0000-121830-H01-RST
19-001693
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Inclusion Criteria:
 

  • 18 years of age or older.
  • Kidney transplant recipient.


Exclusion Criteria:

  • Neuropsychiatric condition causing patient to be unable to provide consent.
  • Non-English speaking patient.
  • Failed kidney transplant defined as return to dialysis.
Kidney transplant, Transplanted kidney present
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A Phase 3 Global, Double-Blind, Randomized, Placebo‑Controlled Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Transthyretin‑Mediated Amyloid Cardiomyopathy (ATTR CM) (ATTR CM)

A Study to Evaluate the Effectiveness and Safety of AKCEA-TTR-LRx in Patients with ATTR CM

Grace Lin
All
18 years to 90 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122706-P01-RST
19-009942
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Inclusion Criteria:

  • Must have given written informed consent (signed and dated) and any authorizations required by local law and be able to comply with all study requirements.
  • 18 to 90 years of age (inclusive).
  • Females: must be non-pregnant and non-lactating and either:
    • surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy);
    • post-menopausal (defined as 12 months of spontaneous amenorrhea in females > 55 years of age or, in females ≤ 55 years, 12 months of spontaneous amenorrhea without an alternative medical cause and folliclestimulating hormone (FSH) levels in the post-menopausal range for the laboratory involved);
    • abstinent*; or
    • if of child-bearing potential and engaged in sexual relations, agree to use 1 highly effective contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of Study Drug (ION‑682884 or placebo).
  • Males must be surgically sterile or abstinent*; if engaged in sexual relations with a female of child-bearing potential, the patient must be using an acceptable contraceptive method from the time of signing the informed consent form until at least 24 weeks after the last dose of Study Drug.

*Abstinence is only acceptable as true abstinence; i.e., when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception.

  • Willing to be genetically tested for mutations in the TTR gene during screening, if it was not done before.
  • Amyloid deposits in cardiac or non-cardiac tissue confirmed by Congo Red (or equivalent) staining OR technetium scintigraphy (99mTc -3,3-diphosphono-1,2- propanodicarboxylic acid [DPD-Tc], 99m Tc-pyrophosphate [PYP-Tc], or 99mTc-hydroxymethylene-diphosphonate [HMDP-Tc]) with Grade 2 or 3 cardiac uptake in the absence of abnormal light chains ratio, centrally confirmed.
  • End-diastolic interventricular septum thickness of > 12 mm on Screening echocardiogram.
  • Medical history of HF secondary to hereditary or wild-type ATTR-CM with at least:
    • 1 prior hospitalization for HF, which may include hospitalization for arrhythmia or pacemaker/ICD (implantable cardioverter defibrillator) placement; OR
    • symptoms and signs of volume overload or elevated intracardiac pressure that either requires or required treatment with diuretics for clinical stabilization.
  • Screening N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥ 600 pg/mL by central lab. For patients in atrial fibrillation at Screening the eligibility NT-proBNP value is ≥ 1200 pg/mL.
  • New York Heart Association (NYHA) class I-III.
  • 6MWT ≥ 150 meters.
  • If on medical treatment for HF, stable medication regimen for at least 2 weeks prior to randomization.
  • Willingness to adhere to vitamin A supplementation per protocol.


Exclusion Criteria:

  • Acute coronary syndrome, unstable angina, stroke, transient ischemic attack (TIA), coronary revascularization, cardiac device implantation, cardiac valve repair, or major surgery within 3 months of Screening.
  • Hospitalization or urgent visit to emergency department/emergency room (ED/ER) for worsening of HF within 4 weeks prior to or during Screening.
  • Uncontrolled hypertension (systolic blood pressure [BP] > 160 or diastolic BP > 100 mmHg).
  • Uncontrolled clinically significant cardiac arrhythmia, per Investigator’s assessment (e.g., no pacemaker, although indicated).
  • Severe, uncorrected, cardiac valvular disease.
  • Cardiomyopathy not primarily caused by ATTR-CM, for example, cardiomyopathy due to hypertension, valvular heart disease, or ischemic heart disease.
  • Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a patient unsuitable for inclusion:
    • Alanine aminotransferase/aspartate aminotransferase (ALT/AST) > 2.0 × upper limit of normal (ULN);
    • Total bilirubin ≥ 1.5 × ULN (patients with total bilirubin ≥ 1.5 × ULN may be allowed on study if indirect bilirubin only is elevated, ALT/AST is not greater than the ULN, and known to have Gilbert’s disease);
    • Platelets < lower limit of normal (LLN; central laboratory);
    • Urine protein creatinine ratio (UPCR) ≥ 750 mg/g. In the event of UPCR above this threshold, ineligibility may be confirmed by a repeat random spot UPCR ≥ 750 mg/g;
    • Positive test (including trace) for blood on urinalysis. In the event of a positive test ineligibility may be confirmed with urine microscopy showing > 5 red blood cells per high power field in women, this exclusion criterion must be assessed outside of menstrual period;
    • Estimated glomerular filtration rate (eGFR) < 30 mL /min/1.73 m^2 at Screening [CKD-EPI formula; (Levey et al. 2009)]. If the eGFR is thought to be underestimated, the CKD-EPI creatinine-cystatin C equation can be used for confirmation (Inker et al. 2012);
    • Abnormal thyroid function tests with clinical significance per Investigator judgement;
    • Serum retinol level at Screening < LLN (this criterion does not apply to hATTR-CM patients with mutation at the position 84 [e.g., Ile84Ser]);
    • Hemoglobin A1c (HbA1c) > 9.5%.
  • Monoclonal gammopathy of undetermined significance (MGUS) and/or immunoglobulin free light chain ratio < 0.26 and/or > 1.65, unless fat, bone marrow, or heart biopsy confirming the absence of light chain and the presence of TTR protein by mass spectrometry or immunoelectron microscopy.
  • Active infection requiring systemic antiviral or antimicrobial therapy that will not be completed prior to Study Day 1.
  • Known history of or positive test for human immunodeficiency virus (HIV), (as evidenced by positive tests for HIV antibody and HIV RNA), hepatitis C (as evidenced by positive tests for HCV antibody and HCV RNA) or hepatitis B (as evidenced by a positive test for hepatitis B surface antigen).
  • History of bleeding, diathesis or coagulopathy (e.g., liver cirrhosis, hematologic malignancy, antiphospholipid antibody syndrome, congenital disorders such as hemophilia A, B, and Von Willebrand disease).
  • If receiving oral anticoagulants (except vitamin K antagonists), the dose must have been stable for 4 weeks prior to the first dose of Study Drug and regular monitoring must be performed, per clinical practice during the study. If the patient is receiving vitamin K antagonists (e.g., warfarin) INR should be in therapeutic range, as established by the Investigator, for 4 weeks prior to the first dose.
  • Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. Patients with a history of other malignancies who have been treated with curative intent and without recurrence within 5 years may also be eligible per Investigator judgment 14. Prior liver or heart transplant, and/or Left Ventricular Assist Device (LVAD) or anticipated liver transplant or LVAD within 1 year after randomization.
  • Karnofsky performance status of ≤ 50%.
  • Contraindication for immunosuppressive therapy, per Investigator’s discretion.
  • Known Light chain/Primary Amyloidosis (AL).
  • Known leptomeningeal amyloidosis.
  • Known history of multiple myeloma.
  • Treatment with another investigational drug and/or biological agent within 1 month of Screening, or 5 half-lives of investigational agent, whichever is longer.
  • Current or previous treatment with Tegsedi™ (inotersen) or Onpattro™ (patisiran) or other oligonucleotide or RNA therapeutic (including siRNA).
  • Current treatment with diflunisal, doxycycline, non-dihydropyridine calcium-channel blocker (e.g., verapamil, diltiazem). Patients receiving any of these agents must respect a wash-out period of 14 days before randomization.
  • Unwillingness or inability to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator.
  • Other physical, social, or psychological conditions including illicit drug or alcohol use, which, in the opinion of the Investigator would make the patient unsuitable for inclusion, or could interfere with the patient participating in or completing the study.
Drug therapy, Drug, Other
Amyloidosis
Eplontersen [USAN], Hematopoietic system, Transthyretin related familial amyloid cardiomyopathy
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Treatment of Delayed Sleep-Wake Phase Syndrome with Melatonin in Patients with Comorbid Alcohol Use Disorders: A Feasibility Study

A Study to Evaluate Treatment of Delayed Sleep-Wake Phase Syndrome with Melatonin in Patients with Comorbid Alcohol Use Disorders

Bhanuprakash Kolla
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122230-H01-RST
19-005329
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Inclusion Criteria:

  • Subjects 18 years or older admitted to the IAP, an outpatient addiction treatment program.
  • Primary diagnosis of moderate to severe Alcohol Use Disorder.
  • If the subject qualifies for the CRU visit, they must agree to abstain from caffeine during the CRU visit to proceed.


Exclusion Criteria:

  • Currently on melatonin and unwilling to discontinue at least 2 weeks prior to completing the CRU visit.
  • Currently on hypnotic medications (benzodiazepines and trazadone) and unwilling to discontinue for 5 days prior to the CRU visit and for the duration of the study if they meet requirements and begin melatonin treatment following the CRU visit.
  • Unable or unwilling to provide informed consent.
  • Pregnant or considering pregnancy.
  • Diagnosis of any SUD, other than alcohol and mild cannabis use disorder, that has been active in the past 30 days.
Alcohol use disorder, Delayed sleep phase syndrome, Sleep disorders
Alcoholism, Hypersomnia, Melatonin, Nervous system, Sleep-wake schedule disorder, delayed phase type, melatonin
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A Prospective, Multicenter, Randomized, Controlled Pivotal Trial to Evaluate the Safety and Effectiveness of Transcatheter Tricuspid Valve Repair With the Edwards PASCAL Transcatheter Valve Repair System and Optimal Medical Therapy (OMT) Compared to OMT Alone in Patients With Tricuspid Regurgitation (CLASP II TR)

Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial (CLASP II TR)

Mackram Eleid
All
18 years and over
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
0000-122666-P01-RST
19-009423
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Inclusion Criteria:


- Eighteen (18) years of age or older

- Despite medical therapy, per the local Heart Team, patient has signs of TR, symptoms
from TR, or prior heart failure hospitalization from TR.

- Severe or greater tricuspid regurgitation

- New York Heart Association (NYHA) Class II-IVa or heart failure hospitalization in the
prior 12 months

- Patient is at an intermediate or greater estimated risk of mortality with tricuspid
valve surgery as determined by the cardiac surgeon with concurrence by the local Heart
Team

- Patient is able and willing to give informed consent, follow protocol procedures, and
comply with follow-up visit requirements


Exclusion Criteria:


- Tricuspid valve anatomy not evaluable by TTE or TEE

- Tricuspid valve anatomy precludes proper device deployment and function

- Patient with refractory heart failure requiring, advanced intervention (i.e. patient
has or will need left ventricular assist device, or transplantation) (ACC/AHA Stage D
heart failure)

- Presence of trans-tricuspid pacemaker or defibrillator leads which meet one of the
following:

1. Would prevent proper TR reduction due to interaction of the lead with the
leaflets

2. Were implanted in the RV within the last 90 days prior to the point of enrollment

- Primary non-degenerative tricuspid disease

- Previous tricuspid valve repair or replacement that would interfere with placement of
PASCAL

- Clinically significant, untreated coronary artery disease requiring revascularization,
unstable angina, evidence of acute coronary syndrome, recent myocardial infarction

- Significant intra-cardiac mass, thrombus, or vegetation per core lab assessment

- Deep vein thrombosis (DVT) or pulmonary embolism (PE) in the last 180 days

- Recent Stroke

- Active gastrointestinal (GI) bleeding

- Presence of infiltrative cardiomyopathy or valvulopathy (including carcinoid,
amyloidosis, sarcoidosis, hemochromatosis) or significant congenital heart disease,
including but not limited to atrial septal defect, RV dysplasia, and arrhythmogenic RV

- Need for emergent or urgent surgery for any reason, any planned cardiac surgery within
the next 12 months (365 days), or any planned percutaneous cardiac procedure within
the next 90 days

- Any of the following cardiovascular procedures:

1. Percutaneous coronary, intracardiac, or endovascular intervention within the last
30 days prior to the point of enrollment

2. Carotid surgery within 30 days prior to the point of enrollment

3. Direct current cardioversion within the last 30 days prior to the point of
enrollment

4. Leadless RV pacemaker implant within the last 30 days prior to the point of
enrollment

5. Cardiac surgery within 90 days prior to the point of enrollment

- Severe aortic, mitral and/or pulmonic valve stenosis and/or regurgitation

- Known history of untreated severe symptomatic carotid stenosis or asymptomatic carotid
stenosis

- Active endocarditis or recent infection requiring antibiotic therapy

- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen

- Pregnant or planning pregnancy within the next 12 months

- Concurrent medical condition with a life expectancy of less than 12 months in the
judgment of the Investigator

- Patient is currently participating in another investigational biologic, drug, or
device clinical study

- Patient has other medical, social, or psychological conditions that preclude
appropriate consent and follow-up, or the patient is under guardianship

Eligibility last updated 6/21/22. Questions regarding updates should be directed to the study team contact.


- Any patient considered to be vulnerable

Behavioral, Device, Drug
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Prospective, Multicenter, Randomized, Parallel Controlled, Two Arms, Single Blind, Study to Assess the Efficacy and Safety of D-PLEX Administered Concomitantly With the SOC IV Prophylactic Antibiotic Treatment vs. SOC in Prevention of Post-Cardiac Surgery Sternal Infections

A Study to Evaluate the Effectiveness and Safety of D-PLEX in the Prevention of Sternal Infection Post- Cardiac Surgery

Juan Crestanello
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122365-P01-RST
19-006469
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Inclusion Criteria:
 

  • Subjects scheduled to elective and/or urgent median sternotomy for cardiac surgery, who are preoperative hemodynamically stable. 
  • Males and females. 
  • Subjects of age 18 years and older. 
  • Subjects with both Diabetes Mellitus AND BMI ≥ 30 OR Diabetes Mellitus/BMI ≥ 30 AND at least one of the following: 
    • Current/Previous smoking history ≥ 30 pack year;
    • Chronic Obstructive Pulmonary Disease (COPD).
  • Female of childbearing potential should have a negative serum pregnancy test prior to index procedure.
    • Note: All female of childbearing potential must agree to use a highly effective method of contraception (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide) consistently and correctly for the duration of the study. 
  • Subject is willing and able to provide a signed Informed Consent Form and is willing and able to comply with study's procedures including follow-up visits.


Exclusion Criteria:

  • Subjects undergoing partial sternotomy. 
  • Subjects with any preoperative active significant infection. 
  • Subjects that received oral or IV doxycycline during the last 4 weeks prior to screening. 
  • Subjects with sensitivity to doxycycline and/or to tetracycline family of drugs and/or other study drug ingredients. 
  • Subjects with known allergies to more than 3 substances (an allergy questionnaire will be filled during the screening process). 
  • Subjects with history of allergic/hypersensitivity reaction to any substance having required hospitalization and/or treatment with intra-venous steroids/epinephrine or in the opinion of the investigator the patient is at high risk of developing severe allergic/hypersensitivity reactions. 
  • Subjects with uncontrolled Asthma (GINA III-IV). 
  • Subjects with chronic urticaria. 
  • Immunocompromised subjects from any reason, at screening. 
  • Subjects with renal failure requiring dialysis. 
  • Subjects scheduled to major organ transplantation and/or to other significant concomitant surgical procedure. 
  • Subjects scheduled for mechanical assist device. 
  • Subjects scheduled to be treated with preventive negative pressure devices.
  • Subjects undergone Cerebro-Vascular Accident (CVA)/Transient Ischemic Attack (TIA) within the past 3 months prior to randomization. 
  • Subjects that have undergone previously, any cardiac surgery through sternotomy. 
  • Subjects with active or previous malignancy in the chest area. 
  • Any subject with active malignancy or with malignancy that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma of the skin and basal cell carcinoma of the skin, are eligible. 
  • Pregnant or breast-feeding women or women of childbearing age not protected by an effective contraceptive method of birth control (such as double barrier, oral or parenteral hormonal, intrauterine device and spermicide). 
  • Subjects enrolled in any intervention study with an investigational medicinal product and/or received any investigational medicinal product within 30 days or 5½ half-lives of the product prior to enrollment (whichever is longer). 
  • In the opinion of investigator, subject is not eligible to participate in the study and/or to comply with protocol requirements (e.g., due to a cognitive, medical condition or residency distanced from site that may jeopardize Follow-Up visits attendance etc.).
Drug, Other, Radiation, Antibiotic prophylaxis, Drug therapy, Intravenous antibiotic therapy, Administration of prophylactic antibiotic
COPD, Diabetes, Post op infection
Antibiotic therapy, Chronic obstructive lung disease, Diabetes mellitus, Endocrine system, Minimally invasive heart surgery, Postoperative infection, Respiratory system
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TNB383B.0001 - A Multicenter, Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-383B, a Bispecific Antibody Targeting BCMA in Subjects With Relapsed or Refractory Multiple Myeloma

A Study of TNB-383B in Subjects With Relapsed or Refractory Multiple Myeloma

Shaji Kumar
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100731-P01-RST
19-001323
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Inclusion Criteria:
 

  • Subject must be ≥ 18 years of age.
  • Three or more prior lines of therapy with exposure to a PI, an IMiD, and an anti-CD38 antibody (e.g., daratumumab). In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in MM.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.
  • Subject is capable of understanding and complying with parameters as outlined in the protocol and able to sign informed consent.
  • Subject must have adequate bone marrow function, defined as:
    • absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • platelets ≥ 50,000/mm^3;
    • hemoglobin ≥ 8.0 g/dL;
    • Transfusion and / or growth factor support is permitted prior to assessment, but neutrophils, platelets, and hemoglobin must be stable for at least 72 hours after transfusion and / or growth factor administration prior to Screening for the subject to be eligible.
  • Subject must have an eGFR ≥ 30 mL/min as estimated by the MDRD formula.
  • Subject must have total bilirubin ≤ 1.5 × upper limit of normal (ULN; except if the subject has a known diagnosis of Gilbert’s syndrome, in which case bilirubin must be < 3 x ULN).
  • Serum calcium (corrected for albumin) at or below the ULN range (subject may enroll in the setting of hypercalcemia at Screening IF hypercalcemia resolves with standard treatment by Cycle 1 Day 1) prior to study therapy initiation.
  • Measurable Disease: Subject has a diagnosis of MM and documented prior treatment with a PI, an IMiD, and an anti-CD38 mAb (ie, daratumumab) as part of 3 or more lines of therapy. In order to be eligible for this study subjects must not be candidates for treatment regimens known to provide clinical benefit in MM. There is no maximum number of prior regimens and prior bone marrow transplant is acceptable if subject is > 12 weeks (autologous) or > 1 year (allogeneic) status-post transplantation.
  • Measurable disease is defined as at least 1 of the following:
    • Serum M-protein ≥ 0.5 g/dL (≥ 5 g/L);
    • Urine M-protein ≥ 200 mg / 24h;
    • Serum free light chain (FLC) assay: Involved FLC level ≥ 10 mg/dl (≥ 100 mg/L) and an abnormal serum FLC ratio (< 0.26 or > 1.65).
  • Subject has confirmed evidence of relapse / progression from the immediately prior MM therapy, or subject is relapsed / refractory to the immediately prior MM therapy. (‘Refractory’ is defined as subjects with either progressive disease or best response of stable disease to the last therapy; ‘Relapsed / refractory’ is defined as subjects with a history of minimal response [MR] or better response to prior therapy, now with disease progression within 60 days of the last therapy. ‘Relapse’ is defined as previously treated myeloma that progresses and requires initiation of salvage therapy, without meeting IMWG uniform response criteria for relapsed / refractory).
  • Subject has adequate archival tumor bone marrow tissue if available or consents to a fresh pre- treatment bone marrow tumor biopsy.


Exclusion Criteria:

  • Subject has been diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of basal cell or squamous cell carcinoma of the skin, in situ malignancy, low-risk prostate carcinoma after curative therapy, or complete resection / curative therapy of an advanced malignancy.
  • Subject has a history of central nervous system (CNS) involvement by their myeloma.
  • Subject has a history of Grade ≥ 3 peripheral neuropathy.
  • Subject has a history of plasma cell leukemia, POEMS syndrome, or amyloidosis.
  • Subject has received another investigational drug within 21 days of enrollment.
  • Subject has ever received BCMA-targeted therapy. Subjects who have received targeted therapy against non-BCMA targets will not be excluded.
  • Subject has received a peripheral autologous stem cell transplant within 12 weeks or an allogeneic stem cell transplant within 1 year of the first dose of study drug treatment.
  • Subject has any medical or psychiatric condition which in the opinion of the investigator or Study Medical Monitor places the subject at an unacceptably high risk for toxicities, could interfere with successful or safe delivery of therapy, or could interfere with evaluation of the investigational product or interpretation of subject safety or study results. Examples include history of significant mucosal / internal bleeding, major psychiatric illness, drug abuse (including active alcoholism), or known allergy or hypersensitivity to components of the study drug formulation.
  • Subject has received any therapy to treat cancer (including radiation, chemotherapy, biologics, cellular therapies and / or steroids at doses > 20 mg dexamethasone or equivalent) or undergone a major surgical procedure within 21 days, or within 5 half-lives of an anti-cancer drug, prior to the first dose of study treatment, whichever is shorter.
  • Subject has known infection Grade ≥ 2 requiring anti-infective treatment. Upon completion of antibiotics and resolution to Grade ≤ 1, the subject is considered eligible for the study from an infection standpoint.
  • Confirmed positive test results for human immunodeficiency virus (HIV), or subjects with chronic or active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who have a history of HBV or HCV who have documented cures (HBV: hepatitis B surface antigen [HBsAg] negative; HCV: undetectable HCV RNA 24 weeks after the end of treatment) may be enrolled.
  • Major cardiac abnormalities such as but not limited to the following: uncontrolled angina or unstable life-threatening arrhythmias, history of myocardial infarction ≤ 12 weeks before Screening, Class ≥ 3 New York Heart Association congestive heart failure, severe cardiac insufficiency, or persistent QTc prolongation (> 480 msec, QTc Fridericia).
  • If female, subject must not be pregnant or breastfeeding and be either postmenopausal (for at least 12 consecutive months), OR permanently surgically sterile OR for women of childbearing potential practicing at least 1 protocol specified method of female birth control AND 1 protocol specified method of male birth control (vasectomy or condoms), starting at Screening through at least6 months after the last dose of study drug.
  • Subject has unresolved AEs ≥ Grade 2 (NCI CTCAE v5.0) from prior anticancer therapy except for:
    • Alopecia;
    • Peripheral neuropathy (peripheral neuropathy ≥ Grade 3 will be excluded);
    • Anemia or thrombocytopenia (the latter cytopenias must be Grade 4 to trigger exclusion, Grade 3 with symptoms or bleeding, respectively, or return within 72 hours despite transfusion support);
    • Subjects with irreversible toxicity not reasonably expected to be exacerbated by any of the investigational products may be included (e.g., hearing loss) after consultation with the Study Medical Monitor.

Eligibility last updated 2/11/22. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Multiple myeloma
Cancer treatment, Hematopoietic system, Medical Oncology, Relapse multiple myeloma
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A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Study of TJ011133 in Participants With Relapsed/ Refractory Advanced Solid Tumors and Lymphoma

Mojun Zhu
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101036-P01-RST
19-005251
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Inclusion Criteria:
 

Part 1 Dose Escalation:

  • Histological or cytological diagnosis of solid tumor or Hodgkin’s Lymphoma who have relapsed or progressed and who are ineligible for all therapies with demonstrated clinical benefit.
    • Note: there is no limit to the number of prior treatment regimens; or
  • Relapsed/refractory CD20 positive, B-cell NHL who have progressed following at least 2 prior systemic therapies. For aggressive histologies, frontline treatment must have included an alkylating agent; or
  • Relapsed/refractory classical Hodgkin’s Lymphoma who have progressed following at least 2 prior systemic therapies and have progressed on checkpoint inhibitors (for Part 1B only);
  • In Part 1A (45 mg/kg dose cohort only), Part 1B or Part 1C, archival tumor tissue and fresh post-treatment tumor biopsy obtained that allows preparation of the number of slides required in the separate study-specific specimen preparation instructions. Samples will be collected, processed and stored according to a separate laboratory manual.

Part 2 Dose Expansion for Combination Therapy with Rituximab:

  • Relapsed/refractory DLBCL including histologically confirmed de novo (NOS) or transformed DLBCL (including transformation from follicular lymphoma of any grade, gastric MALT lymphoma and non-gastric MALT lymphoma) expressing CD20 by IHC (immunohistochemistry) or flow cytometry, primary mediastinal large B‐cell lymphoma, or T‐cell rich large B cell lymphoma, which are relapsed after at least 2 prior lines of systemic therapy including at least one rituximab-containing regimen or refractory disease to rituximab without better available choices.
  • Confirmed marginal zone or follicular lymphoma (Grade 1-3a) expressing CD20+ by IHC or flow cytometry, relapsed after at least 2 prior line of systemic therapy including at least one rituximab-chemotherapy combination regimen or refractory to rituximab-containing regimen without better available choices; for indolent NHL histology, progression following prior treatment with an alkylating agent is allowed but not required.
    • NOTE: Refractory disease is defined as progression within 6 months of last dose of therapy. Relapsed disease is defined as disease recurrence or PD following a response after more than 6 months after last dose. Patients who received CAR-T therapy are allowed but cannot have progressive disease within 3 months of CAR-T therapy.
    • At least one measurable lesion as defined by Lugano criteria (version 2014).
    • Available fresh metastatic biopsy sample prior to study entry and one mandatory on-treatment tumor biopsy in US clinical sites, unless there is difficulty obtaining the sample (e.g., hard to reach tumors or biopsies requiring surgical intervention). Waiver of biopsy samples must be discussed with the medical monitor. Tumor biopsy samples collected should allow for sample preparation as detailed in the separate study-specific specimen preparation instructions. Mandatory archival pre-treatment or optional ontreatment FFPE tumor tissue that allow for sample preparation as detailed in the separate study-specific specimen preparation instructions will be collected from subjects enrolled at sites in China in the NHL cohort of Part 2.

Part 2 Dose Expansion for Combination Therapy with Pembrolizumab:

  • Locally advanced or metastatic NSCLC that expresses PD-L1 (Tumor Proportion Score (TPS) ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy and checkpoint therapy.
  • Patients with NSCLC must have progressed on treatment with one prior PD1/L1 inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
  • Patients who have had more than 1 prior PD-(L)1 inhibitor may be considered after discussion with the Medical Monitor. PD-1/L1 inhibitor treatment progression is defined by meeting all of the following criteria:
    • has received at least 2 doses of the PD-1/L1 inhibitor (must be an approved PD-1/L1 inhibitor);
    • has been on a continuous regimen of the PD-1/L1 inhibitor for at least 4 months without disease progression;
    • has demonstrated radiographic disease progression after PD-1/L1.
  • Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer with any high-grade serous component and immune-oncology (IO) treatment naive subjects with metastases progressed on or after platinum-containing therapy and are not eligible for further platinum-containing treatment. Patients must meet the following criteria:
    • platinum-refractory, platinum-resistant disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment;
    • must not have progressed during the first 3 months of first line platinum-based therapy or must not have progressed within 3 months after completing first line platinum-based therapy;
    • must not have evidence of bowel obstruction requiring hospitalization and decompression within the past 30 days;
    • must not have ascites that requires therapeutic paracentesis in the last 30 days;
    • must not have tumors with low malignant potential (ie. borderline tumors) or mucinous tumors.
    • Prior lines of therapy to include:
      • Patients must have had 1 to 3 prior lines of therapy including at least one bevacizumab-containing regimen or ineligible for all other available therapies; Or
      • Patients must be in the 4th or 5th line of treatment, irrespective of bevacizumab or who are ineligible for all therapies with demonstrated clinical benefit; Or
      • Patients with known BRCA-positive associated cancer or mutation, prior therapy must include PARP inhibitors (unless contraindicated)
    • At least one measurable lesion as defined by RECIST 1.1 solid tumors.
    • Available fresh metastatic biopsy sample prior to study entry and one mandatory on-treatment tumor biopsy, unless there is difficulty obtaining the sample (e.g., hard to reach tumors or biopsies requiring surgical intervention). Waiver of biopsy samples must be discussed with the medical monitor. Tumor biopsy samples collected should allow for sample preparation as detailed in the separate study-specific specimen preparation instructions.

All Subjects:

  • Males or females, of any race, age ≥ 18 years;
  • Be willing and able to provide written informed consent for the trial.
  • Eastern Cooperative Oncology Group Performance Status 0 or 1.
  • Subjects able to follow the requirements of the study protocol and complete the trial.
  • Women of childbearing potential must:
    • Agree to use at least 2 effective contraceptive methods (1 highly effective method in combination with a barrier method; oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner), one of which must be barrier, from signing the ICF, throughout the study, and for up to 8 weeks following the last dose of TJ011133;
    • If using treatment with rituximab, women of childbearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab;
    • If using treatment with pembrolizumab, women of childbearing potential should continue to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment;
    • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at Screening; and have a negative serum or urine pregnancy test (Investigator’s discretion) within 72 hours prior to Cycle 1 Day -1 of study treatment (note that the screening serum pregnancy test can be used as the test prior to Day -1 study treatment if it is performed within the prior 72 hours);
    • Avoid conceiving for 8 weeks after the last dose of TJ011133;
    • Avoid donation of ova from signing the ICF until 8 weeks after the last dose of TJ011133 (12 months after the last dose of rituximab);
    • Agree to ongoing urine pregnancy testing, if clinically indicated, during the course of the study.
  • Males must agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential and will avoid donation of sperm or having a female partner conceive from the time of signing the ICF, while participating in the study, during dose interruptions, and for at least 90 days after the last dose of study treatment, even if he has undergone a successful vasectomy.
  • Subject with a QT interval corrected for heart rate using Fridericia's formula (QTcF) and/or QT interval corrected for heart rate using Bazett's formula of ≤ 450 msec for males, ≤ 470 msec for females.
  • No systemic anti-cancer therapy within 4 weeks of starting study treatment or at least 5 half-lives (whichever is shorter) before study drug administration, and all AEs have either resolved or stabilized.
    • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy.
  • Adequate bone marrow function in subjects with solid tumors, including the following:
    • Part 1
    • Absolute neutrophil count ≥ 1500/μL (≥ 1.5 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 100 × 10^3μL (≥ 100 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration;
    • Part 2
    • Absolute neutrophil count ≥ 1500/μL (≥ 1.5 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 75 × 10^3μL (≥ 75 × 109 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 8 g/dL without transfusion within 2 weeks of the first study drug administration.
    • Adequate bone marrow function in subjects with NHL, including:
    • Part 1
    • Absolute neutrophil count ≥1000/μL (≥ 1.0 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 100 × 10^3μL (≥ 100 × 10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration;
    • Part 2
    • Absolute neutrophil count ≥1000/μL (≥ 1.0 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 50 × 10^3μL (≥ 50 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration. For sites in China, Platelet ≥ 75 × 10^3μL (≥ 50 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 8 g/dL without transfusion within 2 weeks of the first study drug administration. For sites in China, Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration.
  • Adequate renal function and serum creatine ≤ 1.5 × ULN or estimated serum creatinine clearance of ≥60 mL/min using the Cockcroft-Gault equation.
  • Adequate liver function, including:
    • Total serum bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if the subject has documented Gilbert syndrome);
    • AST and ALT ≤ 2.5 × ULN; ≤ 5.0 × ULN (if there is liver tumor present).
  • Normal parameters within the following (unless the subject is receiving anticoagulant therapy):
    • Prothrombin Time ≤ 1.5 ULN, or 11 to 15 seconds in the absence of a normal range;
    • Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 × ULN;
    • International normalized ratio ≤1.5 × ULN.
  • Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 NCI CTCAE version 5.0 except for AEs not constituting a safety risk by Investigator judgment


Exclusion Criteria:

  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable; i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Subjects with Burkitt’s lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
  • Subjects with mantle cell lymphoma with blastoid and TP53 alterations (applies to Part 1 only, all types of mantle cell lymphoma are excluded in Part 2).
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • Left ventricular ejection fraction 25% of the bone marrow (non-lymphoma subjects only), or any subject who has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease. For NSCLC subjects, radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of trial treatment is not allowed (Parts 1B and Part 2 in combination with pembrolizumab only).
  • Prior treatment with CD47 or SIRPα inhibitors;
  • A woman of childbearing potential who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Pregnant or nursing females or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 8 weeks for TJ011133, 120 days for pembrolizumab and 12 months for rituximab after the last dose of study treatment.
  • Has a diagnosis of immunodeficiency (known active human immunodeficiency virus, hepatitis B virus/hepatitis C virus infection) or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Blood product transfusions within 14 days of Cycle 1 Day 1.
  • Prior autologous stem cell transplant ≤3 months prior to starting TJ011133.
  • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
  • Has received chimeric antigen receptor (CAR) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of starting TJ011133 OR has received prior CAR or CAR-T therapy and progressed within 90 days of infusion.
  • Has received any experimental antibodies or a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Received any vaccine within 7 days of planned start of study therapy. Exceptions may apply with SARS-CoV-2 (COVID-19) vaccine, I-Mab Biopharma will provide up-to-date guidance based on evolving current practices.
  • History of AIHA or autoimmune thrombocytopenia.
  • Any bleeding history within 6 months of planned start of study therapy.
  • Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep venous thrombosis, or pulmonary embolism.
  • Any other significant medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk or that would prevent the subject from complying with the study.
  • Second malignancy within the last 3 years (Part 2 dose expansion cohort only) with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ.
  • Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
  • Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or rituximab and/or any of its excipients;
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Not recovered (i.e., to ≤ Grade 1 or to baseline) from AEs emerging from previous treatments (except alopecia or neuropathy).
  • Incomplete recovery from AEs and/or major surgery (must be ≤ Grade 1).
  • History of a ≥ Grade 3 irAE with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
  • Unwilling or unable to comply with study procedures (including follow-up procedures).

Eligibility last updated 1/19/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Bladder cancer, Cancer, Diffuse large b-cell lymphoma, Fallopian tube cancer, Lung cancer, Lymphoma, Non-Hodgkin's lymphoma, Non-small cell lung cancer, Ovarian cancer, Peritoneal cancer, Tumors and masses
Biological therapy for cancer, Cancer treatment, Carcinoma of fallopian tube, Carcinoma of peritoneum, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Hematopoietic system, Malignant epithelial tumor of ovary, Malignant tumor of fallopian tube, Malignant tumor of urinary bladder, Medical Oncology, Non-small cell lung cancer, Pembrolizumab [USAN:INN], Primary malignant neoplasm of bladder, Primary malignant neoplasm of the peritoneum, Reproductive system, Respiratory system, Rituximab, Secondary malignant neoplastic disease, Solid tumor configuration, Targeted drug therapy, Urinary system, pembrolizumab, rituximab
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The Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridium Difficile Infection

A Study to Evaluate the Role of Mucosal Microbiome in the Development, Clearance and Recurrence of Clostridium Difficile Infection

Purna Kashyap
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122215-H01-RST
19-005222
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Inclusion Criteria:

  • Adults aged 18 and over.
  • Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea.


Exclusion Criteria:

  • Known active pregnancy.
  • Prior diagnosis of C. difficile infection within 2 months of this diagnosis.
  • Other known active gastrointestinal infectious process.
  • Vulnerable adults.
  • Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.
C. difficile infection, General infectious diseases, Mucous membrane disorder
Antibiotic therapy, Inflammatory disease of mucous membrane, Recurrent Clostridium difficile infection, Recurrent infectious disease
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(ECTx) HPN536-2001: A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients with Advanced Cancers Associated with Mesothelin Expression Who Have Failed Standard Available Therapy

Study of HPN536 in Patients with Advanced Cancers Associated With Mesothelin Expression

Andrea Wahner Hendrickson
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101055-P01-RST
19-006158
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Inclusion Criteria:

  • Patients ≥ 18 years of age.
  • One of the following progressive advanced or metastatic cancers:
    • Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant;
    • Pancreatic adenocarcinoma (Part 2, Group 2 only) that is locally advanced, and now with progressive disease on or after front-line treatment;
    • Malignant mesothelioma with epithelioid histology, pleural or primary peritoneal (Part 2, Group 3 only) that is progressive disease following frontline platinum-based chemotherapy;
    • For Part 2 only
      •Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma;
    • Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment;
    • For patients previously treated with systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥ 2 weeks, or at least 5 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks;
    • ECOG performance status of 0 or 1;
    • Adequate bone marrow function, including:
      • Absolute neutrophil count (ANC) ≥ 1500/mm^3 or ≥ 1.5 x 10^9/L;
      • Platelets ≥ 100,000/mm3 or ≥ 100 x 10^9/L;
      • Hemoglobin (Hgb) ≥ 0 g/dL.
    • Adequate renal function, including estimated creatinine clearance ≥ 50 mL/min;
    • Adequate liver function, including:
      • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be < 5 mg/dL;
      • Aspartate and alanine transaminase (AST and ALT) ≤ 2.5 x ULN or AST/ALT ≤ 5 x ULN for patients with liver metastases.
    • Serum albumin ≥ 30 mg/mL.


Exclusion Criteria:

  • Previously treated or current brain metastases.
    • Note: Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry and have no evidence of new or enlarging brain metastases.
  • Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening.
  • History of or known or suspected autoimmune disease.
  • History of clinically significant cardiovascular disease.
  • Second primary malignancy that has not been in remission for greater than 3 years.
  • Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy
Cancer
Biological therapy for cancer, Cancer treatment, Gene expression, Malignant neoplastic disease, Medical Oncology, Cellular therapy
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Identifying Physical Function Trajectories and Biomarkers after Kidney Transplantation

A Study to Identify Physical Function Trajectories and Biomarkers after Kidney Transplantation

Carrie Schinstock
All
18 years to 99 years old
This study is NOT accepting healthy volunteers
0000-122559-H01-RST
19-008538
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Inclusion Criteria:

  • Patients age ≥ 18 years old.
  • Either scheduled to receive or have received a kidney transplant (KT) at Mayo Clinic Rochester, Mayo Clinic Arizona, or Mayo Clinic Florida.


Exclusion Criteria:
 

  • Neuropsychiatric condition causing patient to be unable to provide consent.
  • Scheduled to receive a combined organ transplant.
Transplant disorder
Awaiting transplantation of kidney, Frailty, Kidney transplant, Patient awaiting renal transplant, History of renal transplant
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Randomized, Controlled Trial of Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly

A Study to Evaluate Posterior C1-2 Fusion Versus Bracing Alone for Treatment of Type II Odontoid Process Fractures in the Elderly

Arjun Sebastian
All
65 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-121645-P01-RST
19-000036
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Inclusion Criteria:

  • Ages 65 and older.
  • Presenting with type II odontoid fracture confirmed by CT scan to one of the study centers.
  • Deemed appropriate by the attending surgeon involved for C1-2 posterior cervical fusion procedure if surgical management were to be indicated.
  • Able to independently cooperate in the completion of all study consents, forms and documents.
  • Able to speak, read and write English at an elementary school level.


Exclusion Criteria:

  • Those individuals with previously documented type II odontoid fracture.
  • Those individuals whose odontoid fracture is related to malignancy or infection.
  • Those individuals with associated spinal cord injury.
  • Those individuals with other cervical, thoracic or lumbar injuries requiring surgical intervention.
  • Those individuals with aberrant/anomalous local anatomy which precludes posterior placement of C1/2 instrumentation.
Procedure/Surgery
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EAA173, Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients

Mina Hanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101050-P01-ALCL
19-006110
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Inclusion Criteria:
 

 

  • Patient must be ≥ 18 years of age.                    
  • Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
    • Abnormal serum free light chain (FLC) ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >10 mg/dL by serum FLC assay;
    • Serum M-protein level > 2 gm/dL;
    • Presence of t(4;14) or del 17p or 1q gain by conventional cytogenetics or FISH studies;
    • > 20% plasma cells on biopsy or aspirate;
  • A bone marrow aspirate and/or biopsy is required to be performed within 28 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
    1.  
  • Patient must have measureable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:
    • ≥ 1 g/dL on serum protein electrophoresis;
    • ≥ 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis.
  • NOTE: In the rare situation where the SPEP is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted. SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
  • NOTE:      UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr, and urine in addition to serum must be followed in order to confirm a VGPR or higher response.
  • Patient must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN). Specifically, local interpretation of MRI and PET scans will be used to exclude lytic lesions or plasmacytomas and must be obtained within 60 days prior to randomization.
  • Patient must not have known COPD with FEV1 < 50% or known moderate or severe persistent asthma within 2 years prior to randomization.
  • Patient must have adequate organ and marrow function as defined below (obtained within 28 days prior to randomization):
    • Hemoglobin ≥ 11 g/dL;
    • Platelet count ≥ 100,000 cells/mm^3;
    • Absolute neutrophil count ≥ 1500 cells/mm^3;
    • Calculated creatinine clearance ≥ 30 mL/min;
    • Bilirubin ≤ 1.5 mg/dL;
    • SGPT (ALT) and SGOT (AST) ≤ 2.5 times the upper limit of normal.
  • Patient must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patient must also not have contraindication to DVT prophylaxis/aspirin.
  • Patient must not have more than one focal marrow lesion on MRI of either pelvis or spine.
  • Concurrent use of erythropoietin is not allowed while on study therapy.
  • Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
  • Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
  • Patient must not have active, uncontrolled seizure disorder. Patient must not have had a seizure in the last 6 months.
  • Patient must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome.
  • Patient must have an ECOG performance status 0, 1, or 2.
  • Patients with monoclonal gammopathy of undetermined significance are not eligible.
  • Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
  • Patient must not have active, uncontrolled infection.
  • Patient may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full- dose anticoagulation.
  • Patient should not have New York Heart Association classification III or IV heart failure at baseline.
  • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.
  • Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.
  • Women must not be pregnant due to potential harm to the fetus from Daratumumab and Lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
    • has achieved menarche at some point;
    • has not undergone a hysterectomy or bilateral oophorectomy; or
    • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
    • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy (Men assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment).
    • Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. 
    • Patient should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
    • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

 

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Multiple myeloma, Plasma cell disorders
Biological therapy for cancer, Cancer treatment, Chemotherapy, Daratumumab [USAN:INN], Dexamethasone, Hematopoietic system, Immune system, Lenalidomide, Medical Oncology, Smoldering myeloma, Targeted drug therapy, daratumumab, dexamethasone, lenalidomide
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Mayo Clinic Health System — Albert Lea, MN

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients With Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

A Study to Compare Letrozole With or Without Paclitaxel and Carboplatin in Treating Patients With Stage II-IV Ovarian or Primary Peritoneal Cancer

Mina Hanna
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101134-P01-ALCL
19-009074
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Inclusion Criteria:
 

  • Patients must have the psychological ability and general health that permits completion of the study requirements and required follow up.
  • All women will, by definition, be considered menopausal due to surgical removal of both ovaries prior to trial enrollment.
  • Patients must have newly diagnosed, stage II-IV low-grade serous carcinoma (invasive micropapillary serous carcinoma or invasive grade I serous carcinoma) of the ovary or peritoneum. Tumors must be assessed for nuclear p53 staining.
  • Appropriate stage for study entry based on the following diagnostic workup: 
    • History/physical examination within 14 days prior to registration; 
    • Contrast-enhanced imaging of the chest, abdomen and pelvis within 28 days prior to registration. 
  • Patients must have undergone an attempt at maximal upfront cytoreductive surgery, with either optimal (< 1 cm diameter residual disease/nodule) or suboptimal residual disease (> 1 cm diameter residual disease/nodule) status allowed. 
  • Patients must have undergone a bilateral salpingo-oophorectomy. 
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration .
  • Patients must be within ≤ 8 weeks of primary cytoreductive surgery prior to initial randomization.
  • Patients must be able to take per oral (P.O.) medications. 
  • Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl (within 14 days prior to registration). 
  • Platelets greater than or equal to 100,000 cells/mcl (within 14 days prior to registration).
  • Creatinine less than or equal to 1.5 x upper limit of normal (ULN) (within 14 days prior to registration).
  • Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible if there is no hydronephrosis and the estimated creatinine clearance (CCr) is >= 30 ml/min (within 14 days prior to registration).
  • Bilirubin less than or equal to 1.5 x ULN (within 14 days prior to registration).
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3 x ULN (within 14 days prior to registration).
  • Alkaline phosphatase less than or equal to 2.5 x ULN (within 14 days prior to registration). 
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.


Exclusion Criteria:
 

  • Patients with concomitant invasive malignancy or a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the past five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol. 
  • Patients may not have received neoadjuvant chemotherapy or radiotherapy for the treatment of this disease. 
  • Patients may not have received previous hormonal therapy for the treatment of this disease. 
  • Patients with known hypersensitivity to letrozole or hypersensitivity/intolerance to carboplatin/paclitaxel therapy. 
  • Patients with severe cardiac disease. 
  • Myocardial infarction or unstable angina within 6 months prior to registration. 
  • New York Heart Association (NYHA) Class II or greater congestive heart failure. 
  • Patients with known central nervous system metastases.
  • Patients with active or uncontrolled systemic infection. 
  • Patients with ≥ Grade 2 baseline neuropathy. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
  • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Drug therapy, Hormone therapy, Drug, Administration of antineoplastic agent, Chemotherapy
Cancer, Ovarian cancer, Peritoneal cancer
Cancer treatment, Carboplatin, Chemotherapy, Infinnium, Letrozole, Medical Oncology, Primary low grade serous adenocarcinoma of ovary, Primary malignant neoplasm of the peritoneum, Reproductive system, carboplatin, letrozole, paclitaxel
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Mayo Clinic Health System — Albert Lea, MN

The HeLiX (Hemorrhage During Liver Resection: traneXamic Acid) Trial: Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection: A Randomized Controlled Trial (HeLiX)

A Study to Evaluate Tranexamic Acid (TXA) Versus Placebo to Reduce Perioperative Blood Transfusion in Patients Undergoing Liver Resection

Sean Cleary
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-121759-P01-RST
19-001040
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Inclusion Criteria:

  • Patient scheduled for open or laparoscopic liver surgery. 
  • Age ≥ 18 years old. 


Exclusion Criteria:

  • Severe anemia (hemoglobin (Hgb) levels <90 g/l).
  • Documented arterial or venous thrombosis at screening or in past three months (not including therapeutic portal vein embolization). 
  • Anticoagulants (other than low-molecular-weight heparin (LMWH) or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week. 
  • Known disseminated intravascular coagulation. 
  • Severe renal insufficiency (creatinine clearance (CrCl) <30 ml/min).
  • History of seizure disorder. 
  • Pregnant or lactating (a negative urine pregnancy test must be obtained for women of child bearing potential during the pretreatment evaluation). 
  • Acquired disturbance of colour vision
    •Hypersensitivity to TXA or any of the ingredients. 
  • Unable to receive blood products (i.e., difficulty with cross matching, refuses blood transfusion, or a past history of unexplained severe transfusion reaction). 
  • Previously enrolled in this study.
Drug, Drug therapy, Liver excision, Perioperative care management, Transfusion of blood product, Excision of liver
Blood transfusion, tranexamic acid
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Mayo Clinic — Rochester, MN

R1979-ONC-1625: An Open-label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

An Open-label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti-CD20 X Anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Jose Villasboas Bisneto
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100888-P01-RST
19-003173
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Key

Inclusion Criteria:


- For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL
Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL
grade 3b are ineligible for this cohort but may be included in the "other B-NHL"
cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO)
classification (Swerdlow, 2017).

- Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior
lines of systemic therapy as defined in the protocol

- DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least
2 prior lines of systemic therapy as defined in the protocol

- MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice

- MZL cohort: New enrollment is paused until further notice

- Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL
that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma
and Burkitt-like lymphoma.

- Patients should in the judgment of the investigator require systemic therapy for
lymphoma at the time of study enrollment

- Measurable disease on cross sectional imaging as defined in the protocol documented by
diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)

- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key
Exclusion Criteria:


- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS
Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar
puncture, as appropriate, in addition to the mandatory head CT or MRI).

- Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28
days prior to first administration of study drug, whichever is shorter.

- History of allogeneic stem cell transplantation

- Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy

- Continuous systemic corticosteroid treatment with more than 10 mg per day of
prednisone or anti-inflammatory equivalent within 72 hours of start of study drug

- History of neurodegenerative condition or CNS movement disorder. Patients with a
history of seizure within 12 months prior to study enrollment are excluded

- Another malignancy except B-NHL in the past 5 years, with the exception of
non-melanoma skin cancer that has undergone potentially curative therapy or in situ
cervical carcinoma, or any other tumor that has been deemed to be effectively treated
with definitive local control and with curative intent.

- Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or
hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels
on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other
uncontrolled infections

- Known hypersensitivity to both allopurinol and rasburicase

- Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Eligibility last updated 7/12/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Follicular lymphoma, Lymphoma, Non-Hodgkin's lymphoma
Cancer treatment, Follicular non-Hodgkin's lymphoma, Hematopoietic system, Medical Oncology, Odronextamab [USAN]
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Mayo Clinic — Rochester, MN

Relationship of Markers of Cellular Senescence to Skeletal Parameters in Type 2 Diabetes Mellitus

A Study of the Relationship of Markers of Cellular Senescence to Skeletal Parameters in Type 2 Diabetes Mellitus

Sundeep Khosla
All
50 years to 80 years old
This study is NOT accepting healthy volunteers
0000-122431-H01-RST
19-007181
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Inclusion Criteria:

  • Able and willing to provide informed consent.
  • Postmenopausal women (FSH > 20 IU/L).
  • Aged 50-80 years old.
  • Lean control subjects:  BMI < 25, Hemoglobin A1c <or= 5.9%
  • Obese, non-diabetic subjects:  BMI ≥ 30, Hemoglobin A1c <or= 5.9%
  • Obese, T2DM subjects:  BMI ≥ 30, Hemoglobin A1c > 6.5% (for at least the past 5 years).


Exclusion Criteria:

  • Clinical significant abnormality in any of the screening laboratory studies (see below).
  • Presence of (documented clinical diagnosis of any of the following):
    • Significant liver or renal disease;
    • Malignancy (including myeloma);
    • Malabsorption (as defined by clinical diagnosis);
    • Hypoparathyroidism (as defined by clinical diagnosis);
    • Hyperparathyroidism (as defined by clinical diagnosis);
    • Acromegaly;
    • Cushing’s syndrome;
    • Hypopituitarism;
    • Severe chronic obstructive pulmonary disease;
    • History of cardiac failure;
    • Bleeding disorders or current use of therapeutic doses of anticoagulants other than aspirin.
  • Undergoing treatment with any medications that affect bone turnover, including the following:
    • corticosteroids > 3 months at any time (inhaled steroids acceptable unless used year-round);
    • anticonvulsant therapy for seizures (carbamazepine or phenytoin within the previous year);
    • pharmacological doses of:
      • thiazolidinediones;
      • thyroid hormone (causing decline of thyroid stimulating hormone below normal);
      • Bisphosphonates (within the past 3 years);
      • denosumab, estrogen therapy or treatment with a selective estrogen receptor modulator, or teriparatide (within the past year).
    • Any history of fracture prior to screening.
Diabetes, Obesity, Type 2 diabetes
Endocrine system, Obesity, Postmenopausal state, Reproductive system, Type 2 diabetes mellitus in obese
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Mayo Clinic — Rochester, MN

TRANSCEND CLL 004 - An Open-Label, Phase 1/2 Study of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (017004)

A Study Evaluating the Safety and Effectiveness of JCAR017 to Treat Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Saad Kenderian
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100830-P01-RST
19-001564
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Inclusion Criteria:
 

  • Age ≥ 18 years at the time of consent.
  • Signed written informed consent.
  • JCAR017 monotherapy and ibrutinib + JCAR017 combination cohorts must have diagnosis of:
    • CLL with an indication for treatment based on the Investigator’s opinion and measurable disease (any of the following: bone marrow involvement by ≥ 30% lymphocytes, peripheral blood lymphocytosis > 5 × 10^9 /L, and/or measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly); or
    • SLL (lymphadenopathy and/or splenomegaly and < 5 × 10^9 CD19+ CD5+ clonal B lymphocytes/L [< 5000/µL] in the peripheral blood at diagnosis with measurable disease defined as at least one lesion ≥ 1.5 cm in the greatest transverse diameter) that is biopsy-proven SLL Venetoclax + JCAR017 combination cohorts must have diagnosis of:
    • CLL or SLL with an indication for treatment based on the Investigator’s opinion and measurable disease (any of the following: measurable lymph nodes ≥ 1.5 cm in the greatest transverse diameter and/or hepatomegaly or splenomegaly), and demonstration of CLL cells in the peripheral blood by flow cytometry.
  • Subjects (other than those in the ibrutinib + JCAR017 combination therapy cohort) must have received and failed BTKi treatment or have been deemed ineligible for BTKi therapy due to requirement for full dose anticoagulation or history of arrhythmia. Failure to BTKi is defined as having stable disease or progressive disease (PD) as best response, or progression after previous response, or discontinuation due to intolerance. Intolerance is defined as failure to tolerate treatment due to unmanageable toxicity.
  • Subjects in the JCAR017 monotherapy cohorts must have received previous treatment as follows:
    • Subjects with CLL or SLL and high-risk features, defined as having complex cytogenetic abnormalities (3 or more chromosomal abnormalities), 17p deletion, TP53 mutation, or unmutated immunoglobulin heavy chain variable region (IGHV), must have failed at least 2 lines of prior therapy;
    • Subjects with CLL or SLL and standard-risk features must have failed at least 3 lines of prior therapy.
  • Subjects in the ibrutinib + JCAR017 combination cohorts must either:
    • be receiving ibrutinib, or other BTKi, and progressing at the time of study enrollment; or
    • be receiving ibrutinib, or other BTKi, for at least 6 months with a response less than CR and have high-risk features, as defined in inclusion criterion 5a; or
    • have BTK or phospholipase C gamma 2 (PLCγ2) mutations per local laboratory assessment, with or without progression on ibrutinib; or
    • have previously received ibrutinib, or other BTKi, and have no contraindications to initiate or reinitiate ibrutinib (i.e., ibrutinib was not discontinued due to intolerability and subject has no medical contraindications such as arrhythmia or need for anticoagulation) Subjects in the ibrutinib + JCAR017 combination therapy cohorts enrolled under at least amendment 5, must also meet the below criteria:
    • have progressed on a BTKi and f. have received prior therapy with venetoclax which is considered if they meet one of the following criteria:
      • the subject continued on venetoclax due to disease progression or intolerability and if the subject’s disease met indications for further therapy per iwCLL 2018 criteria; or
      • the subject failed to achieve an objective response within 3 months of initiating therapy. Subjects in the venetoclax + JCAR017 combination cohorts must:
    • Have failed at least 1 prior line of therapy, including having failed BTKi therapy or have been deemed ineligible to receive BTKi, as defined in Inclusion Criterion #4;
    • Be venetoclax naïve (required for dose expansion cohort); or
      • If prior venetoclax, (only for dose escalation cohort) (1) have no contraindications to reinitiation of venetoclax based on prior intolerance and (2) have had at least 6 months elapsed since the last dose of venetoclax, if either of the following criteria are met:
      • the best response was stable disease; or
      • the subject experienced disease progression on venetoclax within 6 months of venetoclax discontinuation.
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
  • Assessed by the Investigator to have adequate bone marrow function to receive lymphodepleting chemotherapy.
  • Adequate organ function, defined as:
    • Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance (Cockcroft and Gault) > 30 mL/min;
    • Alanine aminotransferase (ALT) ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert’s syndrome or leukemic infiltration of the liver);
    • Adequate pulmonary function, defined as ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air;
    • Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) ≥ 40% as assessed by echocardiogram (ECHO) or multiple uptake gated acquisition (MUGA) scan performed within 30 days prior to determination of eligibility Subjects in the venetoclax + JCAR017 combination dose escalation and expansion cohorts must have:
      • Hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 500/mm^3 , and platelets ≥ 75,000/mm^3 , unless cytopenias judged by the Investigator to be due to CLL infiltration of the bone marrow.
  • Subject either currently has central vascular access or is a candidate to receive central vascular access or peripheral vascular access for leukapheresis procedure.
  • If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
  • Females of childbearing potential must either commit to true abstinence from heterosexual contact or agree to use one highly effective method of contraception from screening until at least 1 year after receiving lymphodepleting chemotherapy.
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) pregnancy test result at screening and within 48 hours prior to the first dose of lymphodepleting therapy.
  • Males who have partners of childbearing potential must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential for at least 1 year after receiving lymphodepleting chemotherapy even if he has undergone a successful vasectomy.


Exclusion Criteria:

  • Subjects with known active central nervous system (CNS) involvement by malignancy. Subjects with prior CNS disease that has been effectively treated will be eligible if treatment was completed at least 3 months prior to enrollment with no evidence of symptomatic disease and stable abnormalities on repeat imaging.
  • History of another primary malignancy that has not been in remission for at least 2 years. (The following are exempt from the 2-year limit: nonmelanoma skin cancer, completely resected stage 1 solid tumor with low risk for recurrence, curatively treated localized prostate cancer, cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on Pap smear, and in situ breast cancer that has been completely resected.).
  • Subjects with Richter’s transformation.
  • Prior treatment with any gene therapy product.
  • Active hepatitis B, or active hepatitis C (Subjects with a negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted; subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy), or history of or active human immunodeficiency virus (HIV) infection.
  • Systemic fungal, bacterial, viral, or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
  • Presence of acute or extensive chronic graft versus host disease (GVHD).
  • History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.
  • History or presence of clinically relevant CNS pathology such as epilepsy, generalized seizure disorder, aphasia, stroke with current neurologic sequelae, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, cerebral edema, or psychosis.
  • Pregnant or nursing (lactating) women.
  • Use of any of the following medications or treatments within the noted time prior to leukapheresis:
    • Alemtuzumab within 6 months prior to leukapheresis;
    • Allogeneic hematopoietic stem cell transplant within 100 days prior to leukapheresis;
    • Cladribine within 3 months prior to leukapheresis;
    • Donor lymphocyte infusions (DLI) within 2 months prior to leukapheresis;
    • Radiation including large bone marrow fields such as sternum or pelvis within 6 weeks prior to leukapheresis;
    • Fludarabine within 4 weeks prior to leukapheresis;
    • GVHD therapies such as calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate mofetil, rapamycin, or immunosuppressive antibodies (such as anti-tumor necrosis factor-α [TNFα], anti-interleukin-6 [IL-6], or anti-interleukin-6 receptor [IL-6R]) within 4 weeks prior to leukapheresis;
    • Cyclophosphamide, ifosfamide, bendamustine, chlorambucil, or melphalan within 2 weeks prior to leukapheresis;
    • Therapeutic doses of corticosteroids (defined as > 20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis;
    • Anti-CD20 monoclonal antibodies within 7 days prior to leukapheresis;
    • Venetoclax within 4 days prior to leukapheresis;
    • Idelalisib or duvelisib within 2 days prior to leukapheresis;
    • Lenalidomide or acalabrutinib within 1 day prior to leukapheresis;
    • Experimental agents, including off-label use of approved drugs, within 4 weeks prior to leukapheresis unless progression is documented on the experimental therapy and at least 3 halflives have elapsed prior to leukapheresis.
  • Uncontrolled medical, psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol, as judged by the Investigator; or subject unwillingness or inability to follow the procedures required in the protocol.
  • Progressive vascular tumor invasion, thrombosis, or embolism.
  • Venous thrombosis or embolism requiring treatment but not managed on a stable regimen of anticoagulation.
  • For subjects in the venetoclax + JCAR017 combination cohorts only, concomitant treatment with CYP3A moderate/strong inducers or moderate/strong inhibitors which cannot be discontinued.
Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Chronic lymphocytic leukemia, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
Biological therapy for cancer, Cancer treatment, Chronic lymphoid leukemia, disease, Hematopoietic system, Malignant lymphoma - small lymphocytic, Medical Oncology, Cellular therapy
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Evaluation of Intact FGF23 Performance in Patients with Tumor-induced Osteomalacia (TIO) and X-linked Hypophosphatemia (XLH)

A Study to Evaluate Intact FGF23 Performance in Patients with Tumor-induced Osteomalacia (TIO) and X-linked Hypophosphatemia (XLH)

Alicia Algeciras-Schimnich
All
up to 99 years old
This study is NOT accepting healthy volunteers
0000-122310-H01-RST
19-005975
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Inclusion Criteria:
 

  • Patients with hypophosphatemia or suspected tumor induced osteomalacia (TIO) or suspected or confirmed X-linked hypophosphatemia (XLH).


Exclusion Criteria:
 

  • Patients with iron deficiency and chronic kidney disease as these patients might have elevations of FGF23.
Osteomalacia, Rickets
Familial x-linked hypophosphatemic vitamin D refractory rickets, Hypophosphatemia, Musculoskeletal system, Tumor-induced osteomalacia
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Molecular Mechanisms of Acute Effects of Resistance Exercise - Pilot Study

A Study to Examine the Molecular Mechanisms of Acute Effects of Resistance Exercise

K Nair
All
18 years to 55 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-122394-H01-RST
19-006764
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Inclusion Criteria:

  • Age 18-55 years old.
  • BMI 21.0 – 32.0 kg/m^2.


Exclusion Criteria:

  • BMI > 32.0 kg/m^2.
  • For the 20 participants who are involved in training - participation in structured exercise (>2 times per week for 30 minutes or longer).
  • For the 10 participants in the aerobic arm
    •do not participate in structured exercise > 5 times per week.
  • For all participants
    •cardiovascular, metabolic (type 2 diabetes, fasting plasma glucose at or above 110 mg/dL and untreated hypo- or hyperthyroidism) or renal disease, orthopedic problems that would keep them from being able to perform leg extensions; medications that are known to have an impact on mitochondrial function: 
    • Corticosteroids, opiates, benzodiazepines, tricyclic antidepressants, beta blockers, sulfonylureas, insulin, anticoagulants, barbiturates, insulin sensitizers, fibrates (PPAR gamma agonist), smoking, pregnancy. 
    •  
Procedure/Surgery, Resistive exercise
Hyperinsulinism, Insulin resistance
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Pathophysiology and Outcomes Impact of Intravascular Volume Expansion Profiles in Relation to Neuroendocrine and Renal Function in Post-Acute Heart Failure

A Study to Evaluate the Disease Development and Impact of Intravascular Volume Expansion Profiles in Relation to Neuroendocrine and Renal Function in Post-Acute Heart Failure

Wayne Miller
All
18 years to 90 years old
This study is NOT accepting healthy volunteers
0000-122367-H01-RST
19-006517
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Inclusion Criteria:

  • Age greater than 18 years or older.


Exclusion Criteria:

  • Age < 18 years.
  • Having received any investigational drug or device within 30 days prior to entry into the study.
  • Clinically unstable patients (e.g. systolic blood pressure < 90 mmHg, ongoing requirement for vasopressors or mechanical circulatory support, or mechanical ventilation).
  • Hospitalization within three months prior to study for hemodialysis or an ongoing requirement for hemodialysis or ultrafiltration.
  • Prior organ transplantation or being on a waiting list for organ transplantation.
  • Presence of cardiac conditions such as clinically significant cardiac valve stenosis, hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, or primary arterial pulmonary hypertension (Group 1 PAH).
  • History of blood pressure > 190/115 mmHg or unexplained syncope within the past 3 months.
  • Symptomatic carotid artery disease, known critical carotid stenosis, or stroke within the past 3 months.
  • Clinically significant intrinsic renal disease (eGFR <15 ml/min/1.72m2), renal artery stenosis, or history of fibromuscular dysplasia of the renal arteries.
  • Baseline hemoglobin < 8.5 g/dl, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) that is five times or more the upper limit of normal or bilirubin three times or more the upper limit of normal.
  • History of alcohol abuse within the past 6 months.
  • Women who are pregnant, or breast-feeding.

 

Heart failure
Acute heart failure, Acute on chronic systolic heart failure, Cardiovascular system, Chronic systolic heart failure, Decompensated cardiac failure, Decompensated chronic heart failure, Left heart failure
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The Role of Mucosal Microbiome in Recurrence of Clostridium Difficile Infection

A Study to Evaluate The Role of Mucosal Microbiome in Recurrence of Clostridium Difficile Infection

Purna Kashyap
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122217-H01-RST
19-005227
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Inclusion Criteria:

  • Adults, aged 18 and over.
  • Confirmed C. difficile infection based on positive C. difficile toxin PCR testing and clinical evidence of diarrhea.


Exclusion Criteria:

  • Known pregnancy.
  • Prior diagnosis of C. difficile infection within 2 months prior to this diagnosis.
  • Other known active gastrointestinal infectious process.
  • Known diagnosis of inflammatory bowel disease, microscopic colitis, celiac disease or other inflammatory conditions.
  • Vulnerable adults.
  • Any other disease(s), condition(s) or habit(s) that would interfere with completion of study, or in the judgment of the investigator would potentially interfere with compliance to this study or would adversely affect study outcomes.

Eligibility last updated 9/29/21. Questions regarding updates should be directed to the study team contact.

 

C. difficile infection, General infectious diseases, Mucous membrane disorder
Antibiotic therapy, Inflammatory disease of mucous membrane, Recurrent Clostridium difficile infection, Recurrent infectious disease
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A Phase 1 Cross-over Biodistribution Study of [203Pb]VMT01 for Single Photon Emission Computed Tomography (SPECT) Imaging and [68Ga]VMT02 for Positron Emission Tomography (PET) Imaging of Stage IV Metastatic Melanoma (TIMAR1)

Targeted Imaging of Melanoma for Alpha-Particle Radiotherapy

Geoffrey Johnson
All
18 years to 90 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-122630-H01-RST
19-009098
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​​​​​​

Inclusion Criteria:

  • Ability to understand and willingness to provide informed consent.
  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Male or female, aged ≥ 18 years.
  • Diagnosed with Stage IV metastatic melanoma, or inoperable Stage III equivalent.
  • FDG-PET/CT scan available to serve as baseline; the archived scan date must be within 30 days prior to date of enrollment (date initial ICF signed); images from external facilities are allowed. If no archived FDG-PET/CT scan in window, the baseline scan must be obtained at Screening.
  • Complete blood count with differential, within 14 calendar days prior to enrollment, demonstrating the following:
    • White blood cells (WBC) > 2500/mm^3;
    • Hemoglobin (Hgb) > 9.0 g/dL;
    • Platelets > 60,000/mm^3;
    • Absolute Neutrophil Count (ANC) > 1,250/mm^3
      • If no differential is available in the SOC results for enrollment, a subject may be enrolled without the ANC level. Following enrollment, however, this criterion must be met to proceed in the study.
  • Comprehensive metabolic panel, within 14 calendar days prior to enrollment, demonstrating values within the site’s upper limit of normal (ULN), with the following exceptions:
    • Alanine aminotransferase (ALT) ≤ 3 x ULN;
    • Aspartate aminotransferase (AST) ≤ 3 x ULN;
    • Alkaline phosphatase (ALP) ≤ 2.5 x ULN.
  • Ability to lie flat and still for a minimum of two hours for the SPECT scan.
  • For females of reproductive potential: use of highly effective contraception for at least one month prior to screening, and agreement to use such a method during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner during study participation and for an additional four weeks after the end of last investigational imaging agent administration.
  • Agreement to adhere to Lifestyle Considerations throughout study duration.
  • Documented life expectancy of at least 3 months.
  • Access to most recent biopsy is requested (if tissue is available) at screen or if it is obtained through SOC during an expanded window of acceptability; i.e., throughout entire conduct of study at this site. (An updated consent will be obtained.) If a biopsy is completed as part of routine clinical care prior to IRB closure, the study may request access to this sample for tissue MC1R staining and analysis.


Exclusion Criteria:

  • Active secondary malignancy.
  • Prior treatment (for any reason) with radioactive nuclides; imaging tracers are acceptable.
  • Pregnancy.
  • Lactation.
  • Febrile illness within 48 hours of scheduled imaging procedure.
  • Uncontrolled infection.
  • Treatment with another investigational drug within 30 days prior to enrollment date.
  • Subjects initiating BRAFi drugs between baseline FDG scan and enrollment. Subjects receiving consistent, stable therapy with BRAFi for ≥ 3 months prior to enrollment and who have persistent FDG positive malignant lesions on PET imaging are eligible.
  • eGFR < 50 mL/min/1.73m^2.
  • BMI > 50 kg/m^2.
  • Previous medical history of a condition resulting in anaphylaxis or angioedema.
  • Planned treatment while on study with concomitant investigative agents that do not have disclosed safety profiles in the melanoma population (peer-reviewed publications and investigator’s brochures for phase 2 or 3 trials will be accepted as disclosed safety profiles).

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
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Understanding Sex-Specific Effects of Endocrine Disruption on Physical Activity

A Study to Understand Sex-Specific Effects of Endocrine Disruption on Physical Activity

Emma Fortune Ngufor
All
55 years and over
This study is NOT accepting healthy volunteers
0000-121763-H01-RST
19-001098
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Inclusion Criteria:

  • Currently be 55 years of age or older.
  • 50 participants:
    • Have a history of premenopausal bilateral salpingo-oophorectomy.
  • 50 participants:
    • Have no history of premenopausal bilateral salpingo-oophorectomy.
  • Participants for both cohorts must also be enrolled in another study on premenopausal bilateral salpingo-oophorectomy (IRB #18-008476).
  • Must be willing and able to complete all study activities.
  • Have provided written informed consent.


Exclusion Criteria:

  • They are younger than 55 years of age.
  • They are < 6 months post-chemotherapy.
  • They are < 6 months post-major surgery requiring general anesthesia.

 

Oophorectomy
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