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3159 Study Matches

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LuMIERE: A Phase 1/2, Multicenter, Open-label, Non-randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of 177Lu-FAP-2286 in Patients with an Advanced Solid Tumor (LuMIERE)

A Study of 177Lu-FAP-2286 in Advanced Solid Tumors (LuMIERE)

Ajit Goenka
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
2021-305200-P01-RST
21-007085
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Inclusion Criteria:


- Be ≥ 18 years of age at the time the ICF is signed.

- Consent to submission of archival tumor tissue, if available.

- Adequate bone marrow, hepatic, and renal function.

- ECOG performance status of 0 or 1.

- Life expectancy of at least 6 months.

- Measurable disease per RECIST v1.1.

Phase 1 only:

? Patients must have an advanced/metastatic solid tumor that is refractory to or has
progressed following prior treatment and has no satisfactory alternative treatment options.

Patient enrolled in Phase 2 will have one of several specific tumor types with advanced or
recurrent or metastatic disease following prior therapy.


Exclusion Criteria:


- Active second malignancy that may interfere with the safety or efficacy assessments of
this study

- Symptomatic and/or untreated central nervous system (CNS) metastases or leptomeningeal
disease or with primary tumor of CNS origin. Patients must be clinically stable for at
least 4 weeks without steroid treatment

- Received anticancer treatment ≤ 14 days prior to receiving study treatment (≤ 28 days
prior in case of checkpoint inhibitor or other antibody therapies)

- Received prior radiopharmaceutical therapy or radioembolization, or prior extensive
external beam radiation therapy (EBRT) to bone marrow or any prior EBRT to kidney, or
received any EBRT within 2 weeks prior to administration of study treatment

- Ongoing adverse effects from anticancer treatment > Grade 1, with the exception of
alopecia

- Known incompatibility with contrast media for CT or PET scans. Infection requiring
systemic antibiotics within 2 weeks prior to administration of study treatment

- Impaired cardiac function or clinically significant cardiac disease

- Severe urinary incontinence, voiding dysfunction, or urinary obstruction

- Minor surgery ≤ 5 days, or major surgery ≤ 21 days, prior to administration of study
treatment.

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

- Refusal to use highly effective method of contraception, as applicable

- Pregnant or breastfeeding

- Any other condition that may increase the risk associated with study participation or
interfere with its interpretation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/20/22. Questions regarding updates should be directed to the study team contact.

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A Phase 1/1b Study to Evaluate the Safety and Tolerability of AB308 in Combination With AB122 in Participants With Advanced Malignancies

A Study to Evaluate AB308 in Combination With AB122 in Participants With Advanced Malignancies

Thanh Ho
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305203-P01-RST
21-007097
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Inclusion Criteria:

  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • Male or female participants ≥ 18 years of age (or age ≥ regionally approved age of consent for participation in investigational clinical studies) at the time of signing the informed consent.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • Male and female participants will follow contraception guidelines. 

Disease-specific criteria for dose escalation (Parts A and B):

  • Participants may have any pathologically confirmed solid tumor type for which no standard of care therapy exists, or pathologically confirmed NHL who are refractory or have relapsed on prior chemotherapy regimen and who have not received or are unable to receive allogeneic stem cell transplant (ASCT). Prior autologous stem cell transplant is allowed, but not prior CAR-T therapy;
  • Participants may have received up to and including 5 lines of prior systemic anti-cancer therapies for advanced/recurrent and PD (an unlimited number of prior hormonal therapies) is allowed.

Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):

  • Histologically confirmed, treatment naive, locally advanced or metastatic (stage IIIB ─ IV per AJCC version 8), squamous or non-squamous NSCLC; and
  • Documented high PD-L1 expression with a TPS ≥ 50% (TPS50) by an FDA-approved assay.

Disease-specific criteria for dose-expansion Cohort 2 (melanoma):

  • Histologically confirmed metastatic melanoma; and
  • Have received at least 1 line of prior systemic anticancer therapy (2L+); and
  • Have relapsed following prior PD-L1 therapy.

Disease-specific criteria for dose-expansion Cohort 3 (GI):

  • Histologically confirmed metastatic gastric, GEJ or esophageal cancer with a CPS ≥ 1 (CPS1) by an FDA-approved assay; and
  • Have received at least 1 line of chemotherapy (2L+); and
  • Have not received PD-L1 therapy.

Disease-specific criteria for dose-expansion Cohort 4 (Gyn):

  • Histologically confirmed recurrent or metastatic cervical cancer with CPS1 by an FDA-approved assay; and
  • Have received at least 1 line of chemotherapy (2L+); and
  • Have not received PD-L1 therapy.

Disease-specific criteria for dose-expansion Cohort 5 (DLBCL):

  • The following histologically confirmed DLBCL subtypes as defined per 2016 WHO criteria (Swerdlow, 2016):
    • DLBCL, not otherwise specified (NOS);
    • Germinal center B-cell type (GCB);
    • Activated B-cell type (ABC/non-GCB);
    • Epstein-barr virus (EBV+);
    • Human herpes virus-8 (HHV8+);
    • Primary cutaneous DLBCL;
    • DLBCL with chronic inflammation;
    • High-grade B-cell lymphoma, NOS with MYC and BCL2 and/or BCL6 rearrangements (ie, double-triple-hit lymphomas);
    • Must have received at least two prior lines of systemic therapy (3L+); and
    • Have not received or are unable to receive ASCT. Prior autologous stem cell transplant and CAR-T therapy are allowed.

Disease-specific criteria for dose-expansion Cohort 5 (MM):

  • Documented MM as defined by monoclonal plasma cells in the bone marrow ≥ 10% or presence of a biopsy-proven plasmacytoma;
  • Relapsed or refractory MM after having received at least 3 prior lines of therapy (4L+) that include a proteasome inhibitor, an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody and for which no established therapy for MM is appropriate and available, or intolerant to established therapies;
  • Have not received or are unable to receive ASCT. Prior autologous stem cell transplant and CAR-T therapy are allowed;
  • Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) guidance (Version 1.1) for solid tumor indications, or 1 measurable lesion per Lugano Classification criteria for NHL. The measurable lesion must be outside of a radiation field if the participant received prior radiation.
  • Participants with R/R MM must have measurable disease as defined by at least 1 of the criteria below:
    • Serum M-protein ≥1 g/dL;
    • Urine M-protein ≥ 200 mg/24 h;
    • Serum free light chain (FLC) level ≥ 10 mg/dL provided serum FLC ratio is abnormal.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
  • Confirmation that the most recent archival tissue sample (FFPE block or freshly cut slides) is available that is representative of the cancer under investigation and adequate for central lab testing of PD-L1 expression by immunohistochemistry. If freshly cut slides or FFPE block is not available, archival unstained slides < 12 months old may be used. If archival tissue is not available as described above, participants will be requested to consent to undergo a fresh biopsy of a tumor lesion not previously irradiated (tumors progressing in a prior site of radiation may be considered after sponsor consultation). The biopsy must not put participants at undue risk and the procedure must not be more invasive than a core biopsy as documented in the medical record by the investigator.
  • Participants who received prior immunotherapy will be allowed to participate in this study if:
    • Any Grade 1 to 2 immune-related AE (irAE) that occurred during treatment with antiPD-1 or anti-PD-L1 therapy improved to ≤ Grade 1 and/or is stably controlled on repletion hormonal therapy or physiologic doses of corticosteroids (not to exceed 10 mg/day prednisone equivalent). Steroid therapy and/or immunosuppressive therapy for irAEs has been discontinued for > 30 days prior to study enrollment;
    • Grade 3 irAEs of laboratory abnormalities (asymptomatic) improved to ≤ Grade 1 or baseline and steroid therapy and/or immunosuppressive therapy for irAEs has been discontinued for > 30 days prior to study enrollment.
  • Participants who harbor genomic aberrations for which FDA-approved targeted therapy exists must have received such therapy prior to enrollment, unless such therapy is deemed inappropriate in the opinion of the investigator (e.g., EGFR+/ALK+).
  • Participants with previously treated brain or meningeal metastases must meet the following criteria:
  • No evidence of progression by magnetic resonance imaging (MRI) for at least 4 weeks prior to the first dose.
  • Neurologic symptoms returned to baseline.
  • Carcinomatous meningitis, which is excluded regardless of clinical stability.
  • Prior radiation therapy must have been completed as follows:
  • Prior systemic radiation or whole brain radiation at least 4 weeks before investigational product administration.
  • Prior focal radiotherapy at least 2 weeks before investigational product administration.
  • No radiopharmaceuticals (e.g., strontium, samarium) may have been administered.
  • Negative tests for hepatitis B surface antigen, hepatitis C virus antibody (or hepatitis C qualitative RNA [qualitative]), and HIV-1 and HIV-2 antibody at screening.
    • Note: Participants with treated hepatitis B and/or C with no evidence of active infection may be enrolled.
  • Adequate organ and marrow function, as defined below:
    • Neutrophils ≥ 1500/μL (in absence of growth factor support);
    • Platelets ≥ 100 × 10^3/μL;
    • Hemoglobin ≥ 9.0 g/dL;
    • Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 30 mL/min as determined by Cockcroft-Gault equation (Cockcroft, 1976);
    • AST ≤ 2.5 × ULN without hepatic metastasis and ≤ 5 × ULN with hepatic metastasis;
    • ALT ≤ 2.5 × ULN without hepatic metastasis and ≤ 5 × ULN with hepatic metastasis;
    • Bilirubin ≤ 2 × ULN (except participants with Gilbert’s syndrome who must have total bilirubin < 3.0 mg/dL);
    • Platelets ≥ 75 × 10^3/μL, neutrophils ≥ 1000/μL, and hemoglobin ≥ 8 g/dL (dose-expansion Cohort 5 only).


Exclusion Criteria:

  • Use of any live vaccines against infectious diseases (e.g., influenza, varicella) within 4 weeks (28 days) of initiation of investigational product.
  • Underlying medical conditions that, in the investigator’s or sponsor’s opinion, will make the administration of investigational product hazardous (e.g., interstitial lung disease, active infections requiring antibiotics, recent hospitalization with unresolved symptoms) or obscure the interpretation of toxicity determination or AEs, or concurrent medical condition requiring the use of immunosuppressive medications or immunosuppressive doses of systemic or absorbable topical corticosteroids.
  • History of trauma or major surgery within 28 days prior to the first dose of investigational product.
    • Note that placement of central venous access catheter (e.g., port or similar) is not considered a major surgical procedure.
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and antitumor necrosis factor-α agents) administered at > 10 mg/day prednisone or equivalent within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressant medication during study treatment, with the following exceptions:
    • Participants who received low dose (≤ 10 mg/day prednisone or equivalent), systemic immunosuppressant medications or a 1-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after medical monitor approval has been obtained;
    • Participants who received mineralocorticoids (e.g., fludrocortisone), inhaled or intranasal corticosteroids for chronic obstructive pulmonary disease or asthma, or low dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study after medical monitor approval has been obtained.
  • Participants with NHL who have current or history of CNS lymphoma, or current eligibility for ASCT.
  • Participants with R/R MM with primary or secondary plasma cell leukemia, current or history of CNS involvement or received prior ASCT.
  • Prior treatment with an anti-TIGIT monoclonal antibody.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Positive serum pregnancy test at screening and prior to dosing on Cycle 1 Day 1 (WOCBP only).
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the pre-screening or screening visit through 90 days after the last dose of AB308 in combination with zimberelimab.
  • Any active or documented history of autoimmune disease including, but not limited to, inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis, within 3 years of the first dose of study treatment, except for the following:
    • Type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders such as vitiligo, or alopecia not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger;
    • Endocrinopathies where the participant is stable on hormone replacement therapy;
    • History of Hashimoto syndrome within 3 years of the first of study treatment that resolved to hypothyroidism alone.
  • History of a syndrome that required systemic steroids or immunosuppressive medications, except for vitiligo, or resolved childhood asthma/atopy. Participants with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study.
  • Prior malignancy active within the previous year except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast, or prostate cancer.
  • Prior chemotherapy, targeted small-molecule therapy, immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer), or biologic agents, or use of other investigational drugs (drugs not marketed for any indication) within 28 days or at least 5 half-lives (whichever is shorter) before investigational product administration.
  • Adverse events from prior anti-cancer therapy that have not improved to baseline or Grade 1 (excluding irAEs, ≤ Grade 2 alopecia, or ≤ Grade 2 neuropathy).
  • History of discontinuation of immunotherapy (e.g., anti-PD-1, anti-PD-L1, or anti CTLA-1 antibody) for ≥ CTCAE Grade 3 irAEs.

Eligibility last updated 3/29/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug
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Mayo Clinic — Rochester, MN

Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection (VS)

Enhancing Facial Nerve Neuroprotection and Regeneration Through Omega-3 Supplementation Following Vestibular Schwannoma Resection

Michael Link
All
18 years and over
ERROR
This study is NOT accepting healthy volunteers
2021-305208-H01-RST
21-007120
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Inclusion Criteria:

  • All patients 18 of age or greater.
  • VS on final pathology report.
  • Surgical intervention (RS, MF, TL, other).
  • Primary and revision cases included, including prior radiation.

Exclusion Criteria;

  • History of liver disease or abnormal liver function tests.
  • Diabetic patients with specific contraindication to omega-3 supplementation.
  • History of bleeding disorder, or recommended use of anticoagulation (not including anti-platelets or NSAIDs) during the treatment period.
  • Age less than 18 years.
  • Neurofibromatosis 1 or 2, or schwanomatosis disorders.
  • Non-VS pathology.
  • Patients already taking fish oil/omega-3 supplementation.
Dietary Supplement, Other
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Mayo Clinic — Rochester, MN

Assessing Renal Health in Patients with Chronic Liver Disease with Multiparametric Hepatorenal MRE/MRI (Hepatorenogram) (Magnetic Resonance Elastography (MRE))

Liver and Kidney Magnetic Resonance Elastography Study

Meng Yin
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305211-H01-RST
21-006654
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Inclusion Criteria:

  • Primary liver diseases.
  • Diagnosis of suspected kidney function insufficient with laboratory test.
  • Age ≥ 18 years.


Exclusion Criteria:
 

  • Patients with kidney congenital diseases, such as renal agenesis, hypoplasia, horseshoe kidney, abnormal location kidney, etc.
  • Patients with transplant kidney.
  • Patients with HIV infection (lower immune activity).
  • History of liver transplantation or hepatic resection.
  • Absolute contraindications to MRI including pacemaker, AICD device, cochlear implant, VP shunt, aneurysm clip, a deep brain stimulator, and severe claustrophobia.
  • Women who are pregnant or breastfeeding.
  • Any severe medical condition that, in the opinion of the Principal Investigator, would serve as exclusion criteria for study enrollment.
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Mayo Clinic — Rochester, MN

Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial (BREATHE)

Burnout Reduction and Engagement App-based Trial of Headspace (BREATHE): A Randomized Clinical Trial

Candace Granberg
All
21 years and over
Not Applicable
This study is NOT accepting healthy volunteers
2021-305218-H01-RST
21-007153
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Inclusion Criteria:

  • Being a health-professional at the Urology Department of Mayo Clinic, RST
  • Sign the informed consent and agreed to share data from the app to the research team.
  • *(Participants can withdraw a specific category of data directly from their smartphone) ** (patients who decline enrollment will be invited to take surveys coinciding with trial surveys).


Exclusion Criteria:

  • Using an alternate app designed with the same purpose at the beginning, part and/or entire duration of the study.
  • Not provide any data despite being included in the study​​​​​​​
Other
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Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Pilot Trial (MC211003)

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy

Stephan Thome
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305219-P01-MAIJ
21-011969
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • English speaking.
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
  • At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
  • Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Able to provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • No evidence of residual cancer.
  • Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
      • Platelet count > 100,000/mm^3;
      • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
      • Hemoglobin > 11 g/dL;
      • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
      • Alkaline phosphatase ≤ 1.2 x ULN;
      • Serum creatinine ≤ 1.2 x ULN.

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
  • 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.
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
  • Use of other cannabis products within 30 days prior to registration.
  • History of allergy to cannabis products.

Crossover Re-Registration –

Inclusion Criteria:

  • Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Behavioral, Drug, Other
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Mayo Clinic Health System — Mankato, MN

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy: A Randomized Placebo-controlled Pilot Trial (MC211003)

Topical Cannabidiol (CBD) for the Treatment of Chemotherapy-induced Peripheral Neuropathy

Stacy D'Andre
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305219-P01-RST
21-011969
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Registration

Inclusion Criteria:

  • Age ≥ 18 years.
  • English speaking.
  • Cancer diagnosis of any tumor type with chemotherapy-induced neuropathy.
  • At least 4 out of 10 severity of neuropathy pain and/or tingling per appendix IV.
  • Stable for at least 7 days prior to registration [SJB1] [LCLM2] [GAM3] on medications for neuropathy, if any are being used.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If a urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Able to provide written informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • No evidence of residual cancer.
  • Required Initial Laboratory Values: Following completion of chemotherapy, patients must have had a CBC and serum chemistries, including the following:
      • Platelet count > 100,000/mm^3;
      • Absolute neutrophil count (ANC) ≥ 1,000/mm^3;
      • Hemoglobin > 11 g/dL;
      • Serum transaminase [ALT or AST] ≤ 1.2 x upper limit of normal (ULN);
      • Alkaline phosphatase ≤ 1.2 x ULN;
      • Serum creatinine ≤ 1.2 x ULN.

Registration


Exclusion Criteria:

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons;
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Any medical condition that would prohibit use of a topical cream (skin infection or open wound in the area of the neuropathy).
  • 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.
  • Pre-existing neuropathy prior to chemotherapy that would confuse the issue of CIPN.
  • Currently on chemotherapy or received chemotherapy treatment within the prior 3 months.
  • Use of other cannabis products within 30 days prior to registration.
  • History of allergy to cannabis products.

Crossover Re-Registration –

Inclusion Criteria:

  • Treatment cannot begin prior to registering to the crossover phase and will ideally begin ≤ 7 days after registration for the crossover phase.

Eligibility last updated 1/18/22. Questions regarding updates should be directed to the study team contact.

 

Drug, Other, Behavioral
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Mayo Clinic — Rochester, MN

Starstim: Safety and Therapeutic Measures of Transcranial Cathodal Direct Current Stimulation (TDCS) in Patients with Refractor Focal Epilepsy (Starstim)

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

Brian Lundstrom
All
9 years and over
Not Applicable, Pivotal
This study is NOT accepting healthy volunteers
2021-305228-P01-RST
21-008120
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Inclusion Criteria:


1. 9 years old or older

2. Diagnosis of epilepsy with focal seizures with or without focal to bilateral tonic
clonic seizures (International League Against Epilepsy classification). Diagnosis
established by both clinical history and an electroencephalogram (EEG) consistent with
focal seizures. Note: A normal interictal EEG is consistent with focal seizures if
other data is adequate to provide localization.

3. Epilepsy is refractory to treatment, defined as: failure to achieve adequate seizure
control despite demonstrated compliance, according to medical records, on at least two
(2) FDA-approved ASDs at a daily dose considered therapeutic for the patient's
demographic according to package labeling, within approximately the last 3 years.

4. Seizure frequency >= 3 per month over the past year.

5. Currently on at least 1 ASD, with no changes in antiepileptic drug doses in the 3
weeks prior to baseline visit in the study and no planned dose changes during the
trial. Changes after baseline visit are permitted only if clinically necessary.

6. An MRI scan of the brain using 1.5 Tesla magnet, or greater, with T1, T2, and FLAIR
sequences, performed within the past 3 years and more recently than any craniotomy or
skull burr hole procedure.

7. Seizure focus that allows design of an appropriate stimulation montage Note: Seizure
focus can be identified within a lobe, or 2 adjacent lobes. Identification of the
border of the seizure focus can be approximate (+/- 2 gyri).

8. Available seizure history and supporting data

9. All female study subjects of child-bearing age are required to have a pregnancy test.
Additionally, all females of childbearing potential will be required to use an
effective method of birth control (defined as having a documented failure rate of ≤1%;
for women using enzyme-inducing ASDs hormonal contraceptives will not be considered as
effective).

10. Written informed consent obtained from study subject or subject's legal representative
and ability for study subject to comply with the requirements of the study.

11. Assent from pediatric subjects when appropriate.


Exclusion Criteria:


1. Presence of a condition or abnormality that in the opinion of the Investigator would
compromise the safety of the subject or the integrity of the data.

2. Evidence for more than one seizure focus. (NOTE: For this study, a seizure focus is
defined as a cortical region confined to one hemisphere and either one lobe or on a
junction of two adjacent lobes from which seizures arise, as documented by scalp or
intracranial EEG, that is either supported or not refuted by MRI, and either supported
or not refuted by clinical semiology). If the interictal EEG is normal, a seizure
focus may be identified by the combination of structural findings on MRI and clinical
signs/symptoms associated with the subject's seizures.

3. Seizure focus is one of: interhemispheric, cingulate, or orbitofrontal

4. Seizure focus is hemispheric or poorly defined

5. History of psychogenic non-epileptic seizures in past 2 years, or physiologic
nonepileptic seizures and non-epileptogenic events, including suspicion for or a
significant history of syncope, and any non-epileptic events must be clearly
differentiable from subject's focal seizures based on previously recorded video EEG
showing distinct clinical and electrographic features of the subject's PNES compared
to their epileptic seizures.

6. Seizures of generalized onset

7. Status epilepticus in the last 12 months

8. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may compromise interfere, limit, affect or reduce the subject's
ability to complete a study of 24 weeks duration.

9. Presence of any disease, medical condition or physical condition that, in the opinion
of the Investigator, may adversely impact the safety of the subject or the integrity
of the data.

10. Damaged skin on scalp that may interfere with tDCS stimulation.

11. Pregnant, or unwilling to practice birth control during participation in the study.

12. Nursing mothers.

13. Any cranial metal implants (excluding ?1 mm thick epicranial titanium skull plates and
dental fillings) or medical devices (i.e. cardiac pacemaker, deep brain stimulator,
medication infusion pump, cochlear implant, vagus nerve stimulator).

14. Previous surgeries opening the skull leaving skull defects capable of allowing the
insertion of a cylinder with a radius greater or equal to 5 mm.

15. A history of addiction to, dependence on, abuse of, misuse of, distribution of, or use
of any illicit substance.

 

Eligibility last updated 7/1/22]. Questions regarding updates should be directed to the study team contact.

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A Prospective Registry for the Study of Outcomes and Predictors in Pouchitis and Pouch-Related Disorders (PROP-RD)

PROP-RD: A Prospective Registry for Pouch-Related Disorders

Laura Raffals
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305251-P01-RST
21-007286
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Inclusion Criteria:

  • Patients with pouch-related conditions.
  • Chronic antibiotic refractory pouchitis (CARP).
  • Crohn’s disease (CD) of the pouch.


Exclusion Criteria:

  • None.

 

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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-921352 as Adjunctive Therapy in Subjects with SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE) (SCN8A-DEE)

Study to Evaluate NBI-921352 as Adjunctive Therapy in Subjects With SCN8A Developmental and Epileptic Encephalopathy Syndrome (SCN8A-DEE)

Lily Wong-Kisiel
All
2 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
2021-305257-P01-RST
21-009966
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Inclusion Criteria:

  • Written or oral pediatric assent from the subject if deemed capable of providing assent, and written informed consent from the subject’s parent(s) or legal guardian(s) for subjects < 18 years of age and for subjects ≥ 18 years of age who are not capable of providing consent in accordance with the governing Independent Ethics Committees (IEC)/Institutional Review Boards (IRB) and according to local laws and regulations. Subjects who are ≥ 18 years of age and capable of providing consent should sign an Informed Consent Form (ICF). Informed consent/assent may be done remotely, if allowed and remote consenting procedures are in place.
  • Be a male or female 2 to 21 years of age, inclusive.
  • Have a diagnosis of SCN8A-DEE supported by both clinical and genetic findings outlined as follows:
  • Clinical findings
    •required:
    • Seizure onset prior to 18 months of age;
    • Developmental delay which may have occurred either prior to or with onset of seizures or after.
  • Supportive (not required):
    • Multiple seizure types which include focal seizures (including focal to bilateral tonic-clonic), tonic-clonic seizures, epileptic/infantile spasms, tonic seizures;
    • History or ongoing motor abnormalities including hypotonia, dystonia, choreoathetosis, ataxia, spasticity, hyperekplexia;
    • Episodes of convulsive and nonconvulsive status epilepticus;
    • Beneficial response to sodium channel blockers such as phenytoin, valproate, carbamazepine, lacosamide, lamotrigine, rufinamide, and oxcarbazepine.
  • Genetic findings (both required):
    • Pathological gain of function (GOF) mutation in SCN8A defined as either a previously identified GOF mutation or a presumed pathological GOF mutation. Presumed pathological GOF mutations must be either a missense mutation that is not seen in either parent (de novo) OR a mutation which leads to a hyperfunctioning channel in in vitro function tests. Presumed pathological GOF mutations must not be nonsense mutations or other mutations likely to lead to a truncated protein;
    • No other pathogenic mutation in an additional gene that is known to cause epilepsy and is more likely to cause the epilepsy experienced by the subject.  

Genetic findings required for SCN8A-DEE diagnosis may be based on genetic testing performed previously. The genetic mutation in the subject’s SCN8A gene (b[i]) and the absence of other pathogenic mutations that are more likely to cause the epilepsy experienced by the subject (b[ii]) must be confirmed at screening as part of the comprehensive epilepsy panel genotyping.

  • Have SCN8A-DEE diagnosis confirmed by the DCP.
  • In the 90 days before screening, have a history of on average at least 4 countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per month.
  • Have on average at least 1 countable motor seizure (defined as GTCS, tonic, atonic or FOS with noticeable motor component) per week (4 per 28-day period) and not be seizure-free for more than 20 consecutive days per 28-day period during the baseline period.
  • Have at least 4 weeks of reliably and consistently completed baseline seizure diary data.
  • Being treated with at least 1 other ASM, but no more than 4 ASMs. Epidiolex®/Epidyolex® will be considered an ASM. The dose should be stable for at least 5 half-lives at screening. Vagus nerve stimulator (VNS) and ketogenic diet are not counted as ASMs.
  • Have failed to achieve seizure freedom with at least 2 ASMs.
  • The subject, if using a VNS, must have had the VNS placed at least 3 months prior to screening with stable settings for ≥ 30 days before screening; settings must remain stable throughout the duration of the study.
  • The subject, if on a ketogenic diet, must have started the ketogenic diet at least 30 days prior to screening; diet must be stable, and continue through the duration of the study.
  • Must be using a nocturnal alerting system or practice consistent with standards of care at the time of screening and continue to use this for the duration of the study. Acceptable nocturnal alerting systems or practices include but are not limited to:
    • Parent/caregiver sleeps in the same room as subject;
    • Video- and/or acoustic-based monitoring (e.g., use of baby monitor);
    • Device intended as a seizure alert system (e.g., bracelet devices).
  • Must have an adequate rescue medication regimen per the investigator’s judgment in place at the time of screening and for the duration of the study.
  • Female subjects of childbearing potential must agree to use contraception consistently from screening until the final study visit or 30 days after the last dose of study treatment, whichever is longer.

A female subject of childbearing potential is defined as a female capable of becoming pregnant, which includes subjects who have had their first menstrual cycle (ie, menarche) and are not surgically sterile (ie, bilateral oophorectomy, hysterectomy or bilateral tubal ligation for at least 3 months prior to screening). A male subject of childbearing potential is defined as a subject who has reached spermarche and has not been vasectomized for at least 3 months prior to screening.

  • Highly effective methods of contraception are required for female subjects of childbearing potential:
    • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS);
    • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (which may be oral, intravaginal, or transdermal) initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Progestogen-only hormonal contraception associated with inhibition of ovulation, which may be oral, injected, or implanted initiated and used in accordance with medical direction for at least 3 months prior to screening;
    • Bilateral tubal ligation;
    • Total abstinence from sexual intercourse (periodic abstinence is not acceptable);
    • Sexual partner(s) who had been vasectomized at least 3 months prior to screening with medically confirmed successful procedure;

Male subjects must agree to use effective barrier contraception consistently from screening until 30 days after the last dose of study treatment. The acceptable method of contraception for male subjects is condom with spermicide (cream, spray, foam, gel, suppository, or polymer film).

  • Have a body weight of at least 10 kg.
  • Be able to carry out all the appropriate assessments and take the study treatment with the help of the parent/caregiver in the opinion of the investigator.
  • Te subject’s parent/caregiver is able to accurately identify seizure types, especially countable motor seizures (defined as GTCS, tonic, atonic or FOS with noticeable motor component) and is able to complete seizure diary.


Exclusion Criteria:

  • Have previously been enrolled in this study and received blinded treatment.
  • Have participated in an interventional clinical trial <30 days prior to screening.
  • Have symptoms that would be more consistent with another epilepsy disorder such as Dravet syndrome (e.g., fever-induced episodes of status epilepticus, frequent myoclonic seizures, worsening on sodium channel blockers).
  • Are currently receiving cannabinoids or medical marijuana except Epidiolex/Epidyolex, unless approved by the Sponsor.
  • Are currently taking systemic steroids (excluding inhaled medication for asthma treatments) such as adrenocorticotropin hormone (ACTH), high dose prednisolone for epileptic spasms.
  • If subject has received these medications in the past, must be off these medications for at least 3 months prior to the screening visit and these drugs may not be initiated during the duration of the study. Intermittent steroids to treat nonepilepsy related diseases (such as allergies or dermatological conditions) are not exclusionary.
  • Are taking strong CYP3A4 inhibitor (e.g., ketoconazole, erythromycin, ritonavir) or inducer (e.g., rifabutin, rifampin, St. John's Wort) other than concurrent ASMs.
  • Have a history of severe drug allergy or hypersensitivity to NBI-921352 or its excipients.
  • Have a previous exposure to NBI-921352.
  • Have any other disorder for which the treatment takes priority over treatment of SCN8A-DEE or is likely to interfere with study treatment or impair treatment compliance.
  • Have a history of moderate or severe head trauma or other neurological disorders or systemic medical diseases that are, in the investigator’s opinion, likely to affect nervous system functioning.
  • Have a clinically significant medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, significant malabsorption, hematologic, pulmonary, psychiatric, or endocrine disease) that in the opinion of the investigator would preclude the subject from participating in and completing the study or that could confound interpretation of study outcome.
  • Are taking or have received disallowed concomitant medication or it is anticipated that the subject will require treatment with at least one of the disallowed concomitant medications during the study.
  • Have clinically significant abnormal vital signs at the screening visit as determined by the investigator.
  • Have one or more clinical laboratory test values outside the reference range, based on blood samples taken at the screening visit, that are of potential risk to the subject’s safety as determined by the investigator, or have at the screening visit:
    • A serum creatine value > 1.5 times the upper limit of the reference range;
    • A total bilirubin value > 1.5 times the upper limit of the reference range;
    • A serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value > 2.5 times the upper limit of the reference range. For subjects on valproate, ALT or AST values up to 3 times the upper limit of the reference range are acceptable, if these values have remained stable over the past 3 months based on investigator judgement.
  • Have, at the screening visit, an ECG finding of a corrected QT interval using Fridericia’s formula (QTcF) > 450 msec or presence of any significant cardiac abnormality.
  • The subject or subject’s parent/caregiver, in the investigator’s opinion, is unlikely to comply with the protocol, including the requirement to travel to the study sites for study visits, or is unsuitable for any reason.
  • Have attempted suicide within the last year or are at significant risk of suicide (either in the opinion of the investigator or defined as a “yes” to suicidal ideation questions 4 or 5 or “yes” to suicidal behavior on the C-SSRS within the past 12-months).
  • Females who are pregnant or currently breastfeeding.
  • Have a history of a positive hepatitis A virus immunoglobulin M (HAV-IgM), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus antibody (HIV-Ab) test results at screening. Subject with positive hepatitis C antibody (HCV-Ab) and confirmatory positive polymerase chain reaction (PCR) reflex test results at screening will be allowed to participate in the study provided that the subject is asymptomatic as assessed by the investigator and does not have exclusionary liver function test abnormalities (ALT, AST, and total bilirubin).
  • Have ingested grapefruit juice or grapefruit products within a 7-day period before Day -1.
Drug, Drug therapy
Encephalopathy, Epilepsy, Grand mal seizure, Seizure
NBI-921352, Nervous system, SCN8A-related epilepsy with encephalopathy
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Mayo Clinic — Rochester, MN

A Phase 3, Double-Blind, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by a Long-Term Safety Extension Period in Children (Ages≥ 2 Years to < 12 Years) With Atopic Dermatitis ((TRuE-AD3) (TRuE-AD3)

A Study to Assess the Efficacy and Safety of Ruxolitinib Cream in Children With Atopic Dermatitis (TRuE-AD3)

Megha Tollefson
All
2 years to 11 years old
Phase 3
This study is NOT accepting healthy volunteers
2021-305264-P01-RST
21-007324
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Inclusion Criteria:

  • Participants diagnosed with Atopic Dermatitis (AD) as defined by the Hanifin and Rajka criteria.
  • Participants with AD duration of at least 3 months (participant/parent/guardian may verbally report signs and symptoms of AD with onset at least 3 months prior).
  • Participants with IGA score of 2 to 3 at the screening and baseline visits.
  • Participants with % BSA (excluding scalp) of AD involvement of 3% to 20% at screening and baseline visits.
  • For children aged 6 years to < 12 years, baseline itch NRS score ≥ 4.
  • Participants/guardians who agree to discontinue all agents used by the participant to treat AD from the screening visit through the final safety follow-up visit.
  • Participants with at least 1 target lesion that measures at least 5 cm^2 at the screening and baseline visits. The target lesion must be representative of the participant's disease state but not located on the hands, feet, or genitalia.
  • Willingness to avoid pregnancy or fathering a child for the duration of study participation.


Exclusion Criteria:

  • An unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator over the previous 4 weeks before the baseline visit. -Concurrent conditions and history of other diseases as follows:
    • Immunocompromised;
    • Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit;
    • Active acute bacterial, fungal, or viral skin infection within 1 week before the baseline visit;
    • Any other concomitant skin disorder, pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of AD lesions or compromise participant safety;
    • Presence of AD lesions only on the hands or feet without prior history of involvement of other classic areas of involvement such as the face or the flexural folds;
    • Other types of eczema;
    • Chronic asthma requiring more than 880 µg of inhaled budesonide or equivalent high dose of other inhaled corticosteroids.
  • Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Use of any of the following treatments within the indicated washout period before the baseline visit:
    • 5 half-lives or 12 weeks, whichever is longer – biologic agents (e.g., dupilumab);
    • 4 weeks – systemic corticosteroids or adrenocorticotropic hormone analogues, cyclosporin, methotrexate, azathioprine, or other systemic immuno-suppressive or immunomodulating agents (e.g., mycophenolate or tacrolimus);
    • 2 weeks – immunizations with live-attenuated vaccines; sedating antihistamines unless on a long-term stable regimen (nonsedating antihistamines are permitted).
    • Note: Live-attenuated vaccines are not recommended during the VC period. Note: COVID-19 vaccination is allowed;
    • 1 week – use of topical treatments for AD (other than bland emollients; e.g., Aveeno® creams, ointments, sprays, soap substitutes), such as topical antipruritics (e.g., doxepin cream), corticosteroids, calcineurin inhibitors, PDE4 inhibitors, coal tar (shampoo), topical antibiotics, or antibacterial cleansing body wash/soap.
    • Note: Diluted sodium hypochlorite "bleach" baths are allowed as long as they do not exceed 2 baths per week and their frequency remains the same throughout the study.
  • Participants who have previously received JAK inhibitors, systemic or topical.
  • Ultraviolet light therapy or prolonged exposure to natural or artificial sources of UV radiation (e.g., sunlight or tanning booth) within 2 weeks prior to the baseline visit and/or intention to have such exposure during the study, which is thought by the investigator to potentially impact the participant's AD.
  • Positive serology test results at screening for HIV antibody.
  • Current treatment or treatment within 30 days or 5 half-lives (whichever is longer) before the baseline visit with another investigational medication or current enrollment in another investigational drug protocol.
  • In the opinion of the investigator, unable or unlikely to comply with the administration schedule and study evaluations.
  • Employees of the sponsor or investigator or otherwise dependents of them.

Eligibility last updated 5/9/22. Questions regarding updates should be directed to the study team contact.

Drug
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Mayo Clinic — Rochester, MN

LOXO-BTK-20022, A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322) (BRUIN CLL-322)

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Yucai Wang
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305267-P01-RST
21-007472
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Inclusion Criteria:

  • Age 18 and older at time of enrollment.
  • Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria.
  • Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor.
  • Platelets ≥ 50 x 10⁹/liter (L), hemoglobin ≥ 8 grams/deciliter (g/dL) and absolute neutrophil count ≥ 1.0 x 10⁹/L.
  • Adequate organ function.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.
  • Estimated creatinine clearance ≥ 30 milliliters per minute (mL/min).


Exclusion Criteria:

  • Known or suspected Richter's transformation at any time preceding enrollment.
  • Prior therapy with a non-covalent (reversible) BTK inhibitor.
  • Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
  • Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers and/or strong P-glycoprotein (P-gp) inhibitors.
  • Prior therapy with venetoclax.
  • Central nervous system (CNS) involvement.
  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection.
  • Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count.
  • Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days.
  • Active hepatitis B or hepatitis C.
  • Known active cytomegalovirus (CMV) infection.
  • Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA).
  • Significant cardiovascular disease.
  • Vaccination with a live vaccine within 28 days prior to randomization.
  • Patients with the following hypersensitivity:
    • Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax;
    • Prior significant hypersensitivity to rituximab;
    • Known allergy to allopurinol and inability to take uric acid lowering agent.
Drug, Behavioral
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Mayo Clinic — Rochester, MN

NEOD001-301 A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Birtamimab Plus Standard of Care vs. Placebo Plus Standard of Care in Mayo Stage IV Subjects With Light Chain (AL) Amyloidosis (AFFIRM-AL)

A Study to Evaluate the Effectiveness and Safety of Birtamimab in Mayo Stage IV Patients With AL Amyloidosis

Morie Gertz
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305269-P01-RST
21-007322
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Key

Inclusion Criteria:


- Aged ≥18 years and legal age of consent according to local regulations

- Newly diagnosed and AL amyloidosis treatment-naïve with cardiac involvement

- Confirmed diagnosis of AL amyloidosis

- Confirmed Mayo Stage IV AL Amyloidosis as defined by NT-proBNP ≥1800 pg/mL and
Troponin-T >0.03 ng/mL and dFLC ≥18 mg/dL

- Planned first-line chemotherapy contains bortezomib administered subcutaneously
weekly.

Key
Exclusion Criteria:


- Non-AL amyloidosis.

- NT-proBNP >8500 pg/mL.

- Meets the International Myeloma Working Group (IMWG) definition of multiple myeloma

- Subject is eligible for and plans to undergo ASCT or organ transplant during the
study.

- Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular
arrhythmias, or ECG evidence of acute ischemia, within 6 months prior to the Month
1-Day 1 Visit.

- Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2)
or severe congenital heart disease.

- ECG evidence of acute ischemia or active conduction system abnormalities

- Prior treatment with hematopoietic growth factors, transfusions of blood or blood
products within 1 week of Month 1-Day 1.

- Prior radiotherapy within 4 weeks of Month 1-Day 1.

- Prior treatment with plasma cell-directed chemotherapy, birtamimab, daratumumab, 11-
1F4, anti-serum amyloid P antibody, doxycycline for amyloid, or other investigational
treatment directed at amyloid .

- Waldenström's macroglobulinemia and/or immunoglobulin M monoclonal gammopathy

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

 

Biologic/Vaccine, Other
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Mayo Clinic — Rochester, MN

Ex-vivo Surfaceomics of Patient-Derived Tumors for Next-Generation Cancer Immunotherapies (EVST)

Study of Cell-surface Proteins in Renal Tumors for Future Exploration of New Anticancer Therapies

Fabrice Lucien-Matteoni
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305283-H01-RST
21-006091
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Inclusion Criteria:

  • Age 18+.
  • Able to give informed consent.
  • Newly diagnosed clear-cell renal cell carcinoma.
  • Eligible for radical nephrectomy.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • No previous systemic therapy.
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PISTACHIO (PREEMPTIION OF DISRUPTIVE BEHAVIOR IN CHILDREN) REAL-TIME MONITORING OF SLEEP AND BEHAVIOR OF CHILDREN 3-7-YEAR-OLD RECEIVING PARENT CHILD INTERACTION THERAPY AUGMENTED WITH ARTIFICIAL INTELLIGENCE RANDOMIZED CONTROLLED TRIAL. (PISTACHIO)

Monitoring of Sleep and Behavior of Children 3-7 Years Old Receiving Parent-Child Interaction Therapy with the Help of Artificial Intelligence

Paul Croarkin
All
3 years to 99 years old
Phase 1
This study is NOT accepting healthy volunteers
2021-305294-H01-RST
21-007403
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Inclusion Criteria
•Children:

  • Ages 3-7.
  • Outpatients or Inpatients.
  • Any gender, race or ethnicity.
  • Able to provide developmentally appropriate informed assent, and legal guardians able to provide informed consent .
  • EBP Severity rated above the clinically significant range (≥120; T-score ≥ 60) (Eyberg Child Behavior Inventory- ECBI; Eyberg & Pincus, 1999).
  • Need for more intensive behavioral treatments such as ER visit for behavioral dyscontrol or hospitalization will not be exclusionary or exit criteria.
  • Families approached for participation will be asked to commit to complete the treatment.
  • At least one primary caregiver and the identified child will have to be able to speak and understand English.   

 Exclusion Criteria
•Children:

  • Formal diagnosis of Severe Intellectual disability, Autistic Spectrum Disorder Level 3, or a psychotic disorder for the child.
  • Parents not consenting to the study.
  • Parents or child is not able to adhere to the study protocol.
  • A Child who is reasonable expected to be unable to tolerate wearing the Garmin device for at least 70% of the time during the day and night 70% of the days during the treatment (12 weeks). This is based on the principal investigator’s discretion.
  • Unable to speak and understand English. 
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
  • Children in foster care.

Inclusion Criteria
•Adults:

  • Agree to wear Garmin watch.
  • Ages 18-99.
  • Any gender, race, ethnicity.
  • Able to provide informed consent.

Exclusion Criteria
•Adults:

  • Unable to speak and understand English. 
  • Refusal or withdrawal of consent, inability, or unwillingness to adhere to study procedures.
Behavioral
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Home Visual Acuity Testing (X06)

Home Visual Acuity Testing

Erick Bothun
All
3 years to 17.5 years old
This study is NOT accepting healthy volunteers
2021-305312-P01-RST
21-007441
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Inclusion Criteria:

  • Age 3 to 17.5 years.
  • If the child wears contact lenses, the child must be able to perform all testing (in office and at home) in spectacle correction without contact lenses.

Eligible families will:

  • Have an iPhone 6 or a later version (excluding first generation iPhone SE) with them at the office visit.
  • The iPhone screen must not have cracks or damage that would decrease legibility of the letters presented (The screen will be checked by a study team member to assure there is no screen damage that would affect legibility of optotypes).
  • Be able to successfully download the age appropriate (ATS-HOTV or e-ETDRS) iPhone application to their iPhone, with assistance from office staff, if needed.
  • Successfully perform the phone-based VA test at the enrollment visit with the participant wearing his/her current optical correction (if worn), with assistance from office staff, if needed.
  • Be able to use the same iPhone to measure VA at home.
  • Be able to have the same adult administer the home VA test for all required home VA tests.
  • Be able and willing to test VA at home 3 days after enrollment (Home test 1) and 1 day after Home test 1 (Home test 2).
  • Be willing to test VA at home within 2 days prior to a subsequent return office visit 3 months after enrollment.
  • Be willing to return for a 3-month office visit.

Participant


Exclusion Criteria:

  • Use of atropine in the last 30 days, including the day of enrollment.
  • Use of atropine expected in the upcoming four months.
  • Aphakia (one or both eyes).
  • Dilation and cycloplegia within 48 hours of the first in-office VA measure.
  • Any cognitive or physical limitations of the participant or parent that would limit their.
  • Ability to perform the phone-based testing at home or in-office testing.

 

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Mayo Clinic — Rochester, MN

Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic (OHD)

Observational Study of Wearable Health Monitoring Device

Eric Vargas Valls
All
22 years to 60 years old
This study is NOT accepting healthy volunteers
2021-305321-H01-RST
21-007489
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Inclusion Criteria:
  

  • Age 22 to 60.
  • Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
  • Commitment to wear device without removing for entire study period.
  • Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
  • Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT&T.
  • Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.


Exclusion Criteria:
   

  • Unable to give consent.
  • Unwillingness to utilize email address for device instructions, surveys, and reminders.
  • Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
  • Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
  • Subjects with a pacemaker or an implanted electronic device.
  • Subjects scheduled or likely to conduct MRI within the study period.
  • Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
  • Patients with severe systemic diseases.

Eligibility last updated 2/24/22. Questions regarding updates should be directed to the study team contact.

 

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Profiling of Tumor-Derived Extracellular Vesicles and Circulating CD8+-T cells for Prediction of Response to Immunotherapy in Metastatic Renal Cell Carcinoma (RCCEV)

Predicting Immunotherapy Response in Metastatic Kidney Cancer

Fabrice Lucien-Matteoni
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305346-H01-RST
21-006090
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Inclusion Criteria:

  • Age 18+.
  • Able to give informed consent.
  • Newly diagnosed metastatic renal cell carcinoma.
  • Eligible for immunotherapy.


Exclusion Criteria:

  • Unable of unwilling to provide informed consent.
  • Previous systemic therapy.

Eligibility last updated 8/11/21. Questions regarding updates should be directed to the study team contact.

 

 

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BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA), 10402 (BAY 1895344)

BAY 1895344 Plus Topoisomerase-1 (Top1) Inhibitors in Patients with Advanced Solid Tumors, Phase I Studies with Expansion Cohorts in Small Cell Lung Carcinoma (SCLC), Poorly Differentiated Neuroendocrine Carcinoma (PD-NEC) and Pancreatic Adenocarcinoma (PDA)

Thorvardur Halfdanarson
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2021-305360-P01-RST
21-007668
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Inclusion Criteria:


- DOSE ESCALATION COHORTS: Patients must have a biopsy-proven solid tumor that is
metastatic or unresectable and has progressed on at least one line of standard therapy

- DOSE ESCALATION COHORTS: Patients must have a solid tumor for which irinotecan or
topotecan is considered standard of care

- DOSE EXPANSION COHORTS: Patients must have biopsy proven metastatic or unresectable
small cell lung cancer (SCLC), poorly differentiated neuroendocrine carcinoma (PD-NEC)
(any extrapulmonary neuroendocrine carcinoma with small cell or large cell histology)
or pancreatic adenocarcinoma (PDA) and have progressed on at least one line of
standard therapy

- DOSE EXPANSION COHORTS: Patients must have at least one measurable lesion outside of
the lesion to be biopsied

- Patients must be able to swallow pills

- Age >= 18 years. Because no dosing or adverse event data are currently available on
the use of BAY 1895344 in combination with irinotecan or topotecan in patients < 18
years of age, children are excluded from this study

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Hemoglobin > 9 g/dL

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 100,000/mcL

- Total bilirubin =< 2 x institutional upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 x institutional ULN

- Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2

- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months are eligible for this trial

- 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

- Patients with treated brain metastases are eligible if follow-up brain imaging after
central nervous system (CNS)-directed therapy shows no evidence of progression.
Furthermore, these patients must be asymptomatic from previously treated brain
metastases (e.g. not on steroids for neurologic symptoms within 30 days of study
enrollment)

- Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial

- Patients with known history or current symptoms of cardiac disease, or history of
treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac
function using the New York Heart Association Functional Classification. To be
eligible for this trial, patients should be class 2B or better

- The effects of BAY 1895344 on the developing human fetus are unknown. For this reason
and because DNA-damage response inhibitors as well as other therapeutic agents used in
this trial are known to be teratogenic, women of child-bearing potential and men must
agree to use adequate contraception (hormonal or barrier method of birth control;
abstinence) prior to study entry and for the duration of study participation and for 6
months after completion of BAY 1895344 administration. Should a woman become pregnant
or suspect she is pregnant while she or her partner is participating in this study,
she should inform her treating physician immediately. Men treated or enrolled on this
protocol must also agree to use adequate contraception prior to the study, for the
duration of study participation, and 6 months after completion of BAY 1895344
administration

- Patient must have the ability to understand and the willingness to sign a written
informed consent document. Participants with impaired decision-making capacity (IDMC)
who have a legally-authorized representative (LAR) and/or family member available will
also be eligible


Exclusion Criteria:


- Patients who have previously been treated with irinotecan will not be eligible to
participate in the irinotecan arm and patients who have previously been treated with
topotecan will not be eligible to participate in the topotecan arm. However, patients
who previously received irinotecan may be treated with topotecan (and vice versa)
should the other agent be considered a possible standard of care for their disease.
Patients who have previously been treated with BAY 1895344 will be excluded from the
study

- Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
nitrosoureas or mitomycin C) prior to entering the study

- Patients who have not recovered from adverse events due to prior anti-cancer therapy
(i.e., have residual toxicities > grade 1) with the exception of alopecia and
endocrinopathies from prior immunotherapy

- Patients who are receiving any other investigational agents

- The investigator(s) must state a medical or scientific reason if patients who have
brain metastases will be excluded from the study

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to BAY 1895344 or other agents used in study

- Patients receiving any medications or substances that are substrates of CYP3A4 with a
narrow therapeutic window, or strong inhibitors/inducers of CYP3A4 are ineligible, if
they cannot be transferred to alternative medication. Because the lists of these
agents are constantly changing, it is important to regularly consult a
frequently-updated medical reference. As part of the enrollment/informed consent
procedures, the patient will be counseled on the risk of interactions with other
agents, and what to do if new medications need to be prescribed or if the patient is
considering a new over-the-counter medicine or herbal product

- Patients with uncontrolled intercurrent illness

- Patients with psychiatric illness/social situations that would limit compliance with
study requirements

- Pregnant women are excluded from this study because BAY 1895344 is agent with the
potential for teratogenic or abortifacient effects. Because there is an unknown but
potential risk for adverse events in nursing infants secondary to treatment of the
mother with BAY 1895344, breastfeeding should be discontinued if the mother is treated
with BAY 1895344. These potential risks may also apply to other agents used in this
study

- Patients with an uncontrolled infection requiring IV antibiotics will not be eligible
to participate in the study

- Patients on strong CYP3A4 inhibitors must discontinue them at least 1 week prior to
starting irinotecan therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.

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EA8192, A Phase II/III Trial of MEDI4736 (Durvalumab) and Chemotherapy for Patients With High Grade Upper Tract Urothelial Cancer Prior to Nephroureterectomy

Testing the Addition of MEDI4736 (Durvalumab) to Chemotherapy Before Surgery for Patients With High-Grade Upper Urinary Tract Cancer

Lance Pagliaro
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305361-P01-RST
21-007652
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Inclusion Criteria:

  • Patient must have the ability to understand and the willingness to sign a written informed consent document.
  • Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.
  • Patient must have a diagnosis of high grade upper tract urothelial carcinoma proven by biopsy within 60 days prior to registration with one of the following:
    • Upper urinary tract mass on cross-sectional imaging; or
    • Tumor directly visualized during upper urinary tract endoscopy before referral to medical oncology;
      • NOTE: Biopsy is standard of care (SOC) and required for enrollment to study. This is vital for best practice.
    • Leukocytes ≥ 3,000/mcL (obtained ≤ 14 days prior to registration);
    • Platelets ≥ 100,000/mcL (obtained ≤ 14 days prior to registration);
    • Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (or ≤ 2.5 x ULN for patients with Gilbert's disease) (obtained ≤ 14 days prior to registration);
    • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x institutional ULN (obtained ≤ 14 days prior to registration);
    • Hemoglobin (Hgb) ≥ 9 g/dL (obtained ≤ 14 days prior to registration);
      • NOTE: Packed red blood transfusion is allowed to achieve this parameter as per treating investigator.
    • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial;
      • NOTE: These patients must be stable on their anti-retroviral regimen with evidence of at least two undetectable viral loads within the past 6 months on the same regimen; the most recent undetectable viral load must be within the past 12 weeks. They must have a CD4 count of greater than 250 cells/mcL over the past 6 months on this same anti-retroviral regimen and must not have had a CD4 count < 200 cells/mcL over the past 2 years, unless it was deemed related to the cancer and/or chemotherapy induced bone marrow suppression. They must not be currently receiving prophylactic therapy for an opportunistic infection and must not have had an opportunistic infection within the past 6 months.
      • NOTE: For patients who have received chemotherapy in the past 6 months, a CD4 count < 250 cells/mcL during chemotherapy is permitted as long as viral loads were undetectable during this same chemotherapy. They must have an undetectable viral load and a CD4 count ≥ 250 cells/mcL within 7 days of registration.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
    • NOTE: Testing for HIV, hepatitis B or hepatitis C is not required unless clinically indicated.
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and have undetectable viral load. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.
  • Patient must have a body weight of > 30 kg.
  • Patient must have a life expectancy of ≥ 12 weeks.
  • Patient must have a creatinine clearance > 15 ml/min as by Crockroft-Gault or 24-hour creatinine clearance within 28 days prior to registration.
    • NOTE: Patients will be assigned to cisplatin-ineligible and cisplatin-eligible cohorts based on their creatinine clearance, Eastern Cooperative Oncology Group (ECOG) performance status, and grade (if any) of peripheral neuropathy and hearing loss in keeping with SOC cisplatin contraindications.
  • Patients that are cisplatin-eligible will be randomized to either Arm A or Arm B.
  • Patients that meet the following criteria will be assigned to the cisplatin-ineligible Arm C:
    • Creatinine clearance of > 15 ml/min and ≤ 50 ml/min;
    • Patient must have an absolute neutrophil count (ANC) ≥ 1,000/mcL obtained ≤ 14 days prior to registration;
    • Patient must have ECOG performance status 0-2.
  • Patients that meet the following criteria will be randomized to cisplatin-eligible Arm A or Arm B:
    • Patient must have an absolute neutrophil count (ANC) ≥ 1,500/mcL obtained ≤ 14 days prior to randomization;
    • Patient must have ECOG performance status 0-1;
    • Patient must have left ventricular ejection fraction (LVEF) ≥ 50% by (either multigated acquisition scan [MUGA] or 2-D echocardiogram) obtained within 28 days prior to randomization;
    • Patient must not have peripheral neuropathy ≥ grade 2 or hearing loss ≥ grade 3.


Exclusion Criteria:

  • Patients must not have any component of small cell carcinoma. Other variant histologic types are permitted provided the predominant (≥ 50%) subtype is urothelial carcinoma.
  • Patients must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy. A patient of childbearing potential is defined as any patient, 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);
    • Patients of childbearing potential and sexually active patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse from the time of registration, while on study treatment and for at least 6 months after the last dose of protocol treatment.
  • Patient must have no evidence of metastatic disease or clinically enlarged lymph nodes (≥ 1.0 cm short axis) on imaging required within 28 days prior to registration (solitary slightly enlarged lymph node with negative biopsy is allowed).
    • NOTE: Patients with elevated alkaline phosphatase, calcium or suspicious bone pain/tenderness should also undergo baseline bone scans to evaluate for bone metastasis.
  • Patient must not have another active (or within 2 years) second malignancy other than resected non-melanoma skin cancers, resected in situ breast, cervical or other in situ carcinoma, and either clinically insignificant per the investigator (e.g., ≤ Gleason 3+4) on surveillance or previously treated prostate cancer with no rising prostate specific antigen (PSA) and no plan to treat.
    • NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients in whom concomitant or prior bladder/urethra predominant (≥ 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed.
  • Patient must not have any uncontrolled illness including, but not limited to, ongoing or active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), symptomatic congestive heart failure (CHF), myocardial infarction (MI) in last 3 months, or unstable angina pectoris, significant uncontrolled cardiac arrhythmia, liver cirrhosis, interstitial lung disease, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Patient must not have received prior radiation therapy to ≥ 25% of the bone marrow for other diseases.
  • Patient must not have received prior systemic anthracycline therapy.
    • NOTE: Patients who have received prior intravesical chemotherapy at any time for non-muscle invasive urothelial carcinoma of the bladder are eligible.
  • Patient must not have an active autoimmune disease requiring immunosuppressive therapy within 2 years prior to registration or a history of inflammatory bowel disease (inflammatory bowel disease [IBD], colitis, or Crohn's disease), systemic lupus erythematosus, Sarcoidosis syndrome, Wegener syndrome or immune-related pneumonitis or interstitial lung disease.
  • Patients with well-controlled hyper/hypothyroidism, celiac controlled by diet alone, diverticulosis, diabetes mellitus type I, vitiligo, alopecia, psoriasis, eczema, lichen planus, or similar skin/mucosa condition.
  • Patient must not be on or have used immunosuppressive medication within 14 days prior to the first dose of MEDI4736 (MEDI4736 (durvalumab). The following are exceptions to this criterion:
    • Intranasal, inhaled, intra-auricular, topical steroids, or local steroid injections (e.g., intra-articular injection;
    • Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent at the time of enrollment;
    • Steroids as premedications for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication);
    • Patient must not have a concomitant primary urothelial carcinoma of the bladder and/or urethra;
    • NOTE: Patients in whom concomitant or prior bladder/urethra predominant (≥ 50%) urothelial carcinoma have been surgically resected and demonstrated to be only non-invasive cancer (< cT1N0) are eligible regardless of time elapsed.
  • Patient must not have prior history of muscle-invasive urothelial carcinoma with or without systemic chemotherapy (T2-4a and/or N1) within 2 years prior to registration.
    • NOTE: Patients who have no evidence of disease (NED) for more than 2 years from the latest therapy (surgery, radiation, chemotherapy, or clinical trial).
  • Patient must not have received live attenuated vaccine within 30 days prior to the first dose of MEDI4736 (durvalumab), while on protocol treatment and within 30 days after the last dose of MEDI4736 (durvalumab).
  • Patient must not have had a major surgical procedure (as defined by the Investigator) within 28 days prior to registration.
  • Patient must not have a history of allogenic organ transplantation.
Biologic/Vaccine, Drug, Procedure/Surgery
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HS-19-657, A Randomized, Multi-center, Open-label, Active-controlled Phase 3 Trial to Assess the Efficacy and Safety of Octreotide Subcutaneous Depot (CAM2029) Versus Octreotide LAR or Lanreotide ATG in Patients With GEP-NET (SORENTO)

A Trial to Assess Effectiveness and Safety of Octreotide Subcutaneous Depot in Patients With GEP-NET

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305363-P01-RST
21-007673
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Inclusion Criteria:

  • Male or female patient ≥ 18 years old.
  • Histologically confirmed, advanced (unresectable and/or metastatic), and well-differentiated NET of GEP or presumed GEP origin.
  • At least 1 measurable, somatostatin receptor-positive lesion according to RECIST 1.1 determined by multiphasic CT or MRI (performed within 28 days before randomization).
  • ECOG performance status of 0 to 2.


Exclusion Criteria:

  • Individuals < 18 years old.
  • Documented evidence of disease progression while on treatment (including SSAs) for locally advanced unresectable or metastatic disease.
  • Known central nervous system metastases.
  • Consecutive treatment with long-acting SSAs for more than 6 months before randomization.
  • Carcinoid symptoms that are refractory to treatment (according to the Investigator's judgement) with conventional doses of octreotide LAR or lanreotide ATG and/or to treatment with daily doses of ≤600 µg of octreotide IR.
  • Previous treatment with more than 1 cycle of targeted therapies such as mTOR inhibitors or vascular endothelial growth factor inhibitors, or more than 1 cycle of chemotherapy or interferon for GEP-NET
  • Treatment of GEP-NET with trans-arterial chemoembolization or trans-arterial embolization within 12 months before screening.
  • Previously received radioligand therapy (PRRT) at any time..

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

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Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Patient Preferences for Second-line Type 2 Diabetes Medication Treatment Outcomes

Rozalina McCoy
All
21 years and over
This study is NOT accepting healthy volunteers
2021-305377-H01-RST
21-007688
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Inclusion Criteria:

  • ≥ 21 years old.
  • Diagnosis of Type 2 diabetes.
  • Use of ≥ study drug (GLP-1RA, SGLT2i, DPP-4i, SU).


Exclusion Criteria:

  • Insulin use.
  • Cognitive impairment.
  • Terminal or advanced illness.
  • Non-English speaking.
  • Residency in a long-term care setting.
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A Prospective, Multi‐Center Study of the Medtronic Braive™ Growth Modulation System When Used in the Treatment of Pediatric Patients Diagnosed with Juvenile or Adolescent Idiopathic Scoliosis (BRAIVE IDE Study) (BRAIVE IDE)

Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis (BRAIVE IDE)

Annalise Larson
All
9 years to 16 years old
This study is NOT accepting healthy volunteers
2021-305386-P01-RST
21-007823
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Inclusion Criteria:

  • Has a diagnosis of juvenile or adolescent idiopathic scoliosis.
  • Is skeletally immature with a Sanders Score of ≥ 2 to ≤ 5.
  • Has failed conservative care as per investigator’s assessment.
  • Has a main thoracic Cobb angle between 30 and 60 degrees.
  • Has a Lenke Classification of 1A, 1B, or 1C.
  • Has kyphosis ≤ 40 degrees with a sagittal thoracic modifier N or negative.
  • Informed Consent Form/Assent and Authorization to Use and Disclose Health Information (if applicable) have been signed by parent/legal guardian and/or patient/participant per local requirement.


Exclusion Criteria:

  • Has undergone previous spinal fusion procedure(s) at the affected levels.
  • Is pregnant or plans to become pregnant within the first 24‐months of the study.
  • Has a curve that requires instrumentation below L1.
  • Has spinal MRI abnormalities (e.g., CHIARI malformation, Syrinx greater than 4mm, tethered cord).
  • Has any type of non‐idiopathic scoliosis.
  • Has a left‐sided curve.
  • Has an associated syndrome.
  • Has a history of malignant hyperthermia.
  • Has an active or significant risk of infection (immunocompromised).
  • Has inadequate tissue coverage over the operative site as per investigator’s assessment.
  • Has a suspected or documented allergy or intolerance to implant materials.
  • Has a major psychiatric disorder/ history of drug abuse that would interfere with the subject’s ability to comply with study instructions or might confound the study interpretation as per investigator’s assessment (DSM‐5 can be used as a reference).
  • Is a ward of the court/state.
  • Has had prior ipsilateral or contralateral chest surgery.
  • Has severe chronic lung disease (e.g., asthma, bronchiectasis).
  • Has poor bone quality, as determined by the investigator, that may limit anterior fixation.
  • Is unwilling or unable to return for follow‐up visits and/or follow intra‐operative and/or postoperative instructions.
  • Concurrent participation in another clinical study that may add additional safety risks and/or confound study results*.
  • Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study.

*Subjects in concurrent studies can only be enrolled with permission from Medtronic. Please contact Medtronic’s study manager to determine if the subject can be enrolled in the BRAIVE IDE Study. 

Eligibility last updated 11/16/21. Questions regarding updates should be directed to the study team contact.

 

 

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Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Sex Differences in The Objective Assessment of Frailty in Subjects Undergoing Early Outpatient Cardiac Rehabilitation: A Pilot Study

Carmen Terzic
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305396-H01-RST
21-007783
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Inclusion Criteria:

  • Adult 18 years and older.
  • English speaking.
  • Able to provide consent.
  • Has a qualifying indication for cardiac rehabilitation (e.g., Acute coronary syndrome, myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, and stable angina, heart valve disease) and able to participate in cardiac rehabilitation.
  • Olmsted County MN residents. 


Exclusion Criteria:

  • Individuals < 18 years of age.
  • Unwilling to provide consent.
  • Unable to participate in cardiac rehab.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

 

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Optimizing Outcomes of Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

A Study Patients with Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging

Nguyen Tran
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305399-P01-RST
21-007799
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Inclusion Criteria:

  • Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies.
  • Have radiographically measurable disease by RECIST.
  • Eligible for atezolizumab/bevacizumab front line therapy.
  • Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent.


Exclusion Criteria:

  • Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan.
  • Patients with higher than the weight/size limitations of PET/CT scanner.
Behavioral, Drug, Radiation
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Describing the Determinants and Effects of Variation in the Adoption and Use of the NOHARM Pain Management Intervention Among Diverse Surgical Practices

NOHARM Aim 3

Andrea Cheville
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305410-H01-RST
21-007898
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Inclusion Criteria:

  • Participants eligible for this study will be patients on the NOHARM trial registry (e.g., patients that were automatically assigned to receive the NOHARM intervention as part of their surgical care) and/or their charts and members of their care teams, including nurses, doctors, physical therapists, nurse practitioners and physician assistants, and medical assistants.  


Exclusion Criteria:

  • Individuals not on the NOHARM trial registry.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

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A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-401) Administered to Patients with Acute Myeloid Leukemia (AML) following Hematopoietic Stem Cell Transplantation (ARTEMIS) (MRKR-19-401-01)

AML: Treatment of Relapse after Transplant or Extended Maintenance of Remission – Investigational Study (ARTEMIS) Effectiveness of MT-401 in Patients with AML Following Stem Cell Transplant

Mithun Shah
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
2021-305430-P01-RST
21-007911
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Inclusion Criteria:

  • Eligible to receive donor-derived MT-401 following first allogeneic HSCT, are in ≤ second complete remission (CR2), and are MRD negative prior to transplant (including matched sibling, matched unrelated donor with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
    • Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD; or
    • Treatment for relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
      • First relapse (MRD+ or frank relapse) post-HSCT;
      • Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post-HSCT.
    • Safety Lead-in (Cohorts I and II) and Cohort III defined as patients who fit a majority of the criteria described above for Group 2 only (as determined by the Sponsor).
      • Note: Engraftment must be confirmed post-transplant (absolute neutrophil count > 1000/m^3 without granulocyte colony-stimulating factor for 7 days, donor chimerism ≥ 50%).
    • Are ≥ 18 years of age prior to administration of MT-401.
    • Patients must have donor-derived cells available to make MT-401.
    • Karnofsky/Lansky score of ≥ 60.
    • Life expectancy ≥ 12 weeks.
    • Adequate blood, liver, and renal function.
    • Blood: Hemoglobin ≥ 7.0 g/dL (can be transfused).
    • Liver: Bilirubin ≤ 1.5 X upper limit of normal; aspartate aminotransferase ≤ 3 X upper limit of normal.
    • Renal: Serum creatinine ≤ 2 X upper limit of normal or measured or calculated creatinine clearance ≥ 45mL/min.
    • Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period.
    • Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant
    • In Group 2, patients may receive bridging therapy at the investigators’ discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit (particularly in cases of high tumor burden) for ≤ 6 months as long as the following criteria are met:
      • Disease assessment including bone marrow biopsy to be performed within 14 days prior to administration of MT-401 (patients may receive MT-401 even if CR is achieved post-bridging therapy but will be analyzed separately; additionally, patients must have ≤ 50% bone marrow blasts);
      • At least 4 half-lives or 1 week has passed after administration of bridging therapy whichever is longer.


Exclusion Criteria:

  • Clinically significant or severely symptomatic intercurrent infection.
  • Pregnant or lactating.
  • For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401.
  • For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401.
  • Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401.
  • Taking systemic corticosteroids (exception: physiological doses of steroids allowed).
  • On other investigational therapy post-HSCT.
  • Anti-thymocyte globulin or Campath within 28 days of MT-401 infusion.

Donor

Inclusion Criteria:

Donors for allogeneic stem cell transplants must be considered suitable for and consent to stem cell donation, as per the stem cell transplant program's standard operating procedures. If a donor has been chosen for the transplant, that same donor will also be used for T cell generation provided that there are no new reasons for ineligibility since the stem cell collection. The donor clearance by the National Marrow Donor Program (NMDP) is acceptable or the donors will be evaluated as per standard institutional guidelines. Leukapheresis material will be collected from the same HSCT donor to manufacture MT-401 for the patient.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

 

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Cardiolipin Profiling for Barth Syndrome Screening and Characterization (CPfBSSaC)

Cardiolipin Profiling for Barth Syndrome Screening and Characterization

Devin Oglesbee
All
Not specified
This study is NOT accepting healthy volunteers
2021-305433-H01-RST
21-007892
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Inclusion Criteria:

  • Specimens (dried blood spots, whole blood, or retrospectively available cultured cells) from Barth subjects and controls identified by the Barth Syndrome Foundation and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.
  • Residual specimens from the Mayo Clinic Biochemical Genetics Laboratory:
    • Up to 1,000 control subjects from pediatric and adult populations through age 99 on date of relevant specimen collection.
  • Data collected as part of the Barth Syndrome Foundation Registry and Biorepository and/or clinical testing at the Mayo Clinic Biochemical Genetics Laboratory.


Exclusion Criteria:

  • None.

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

 

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Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Effectiveness and Safety of the Dexcom G6 Continuous Glucose Monitoring System in Non-Critically Ill Patients in the Inpatient Setting

Yogish Kudva
All
18 years and over
This study is NOT accepting healthy volunteers
2021-305450-P01-RST
21-007993
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Inclusion Criteria:


- 18 years of age and older

- Admitted to the hospital in a non-ICU bed or once transferred out of ICU

- Anticipate at least 48 hours of hospital stay

- On treatment for glucose control.

- Willingness to complete the study.

- Willingness to wear up to 3 CGM systems simultaneously. Two in the abdomen and one on
the back of the arm or one on each arm and one on the abdomen.

- Subject and/or caretaker are able to speak, read, and write English


Exclusion Criteria:


- Presence of extensive skin changes/diseases at sensor wear site(s) that preclude
wearing the sensor(s) on normal skin (e.g., extensive psoriasis, recent burns or
severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis
herpetiformis)

- Currently in an intensive care unit (ICU) of the following type (does not apply to
participants placed in an ICU bed due to space issues in the non-ICU areas)

- Known allergy to medical-grade adhesives

- Pregnancy, demonstrated by a positive test (for subjects of childbearing potential)

- Women admitted to give birth or any other admission related to pregnancy

- Patients receiving Hydroxyurea

- Bleeding disorder

- Participants that are currently being treated for malignancies, cancer

- Participant that are hospitalized to receive an organ transplant

- Require a Magnetic Resonance Imaging (MRI) scan

- End stage renal disease and currently managed by dialysis or anticipating initiating
dialysis during the study wear period

- Current participation in another investigational study protocol (If a subject has
recently completed participation in another drug study, the subject must have
completed that study at least 7 days prior to being enrolled in this study.)

- Any condition that, in the opinion of the Investigator, would interfere with their
participation in the trial or pose an excessive risk to study staff (e.g., known
history of hepatitis B or C)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/2/22. Questions regarding updates should be directed to the study team contact.

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Mayo Clinic — Rochester, MN

DP-1111-02CT: A Prospective, Randomised, Controlled, Open-label, Multicentre Study to Evaluate Efficacy, Safety and Patient-Reported Outcomes of Peptide Receptor Radionuclide Therapy (PRRT) With 177Lu-Edotreotide Compared to Best Standard of Care in Patients With Well-differentiated Aggressive Grade 2 and Grade 3, Somatostatin Receptor-Positive (SSTR+), Neuroendocrine Tumours of GastroEnteric or Pancreatic Origin (COMPOSE)

Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE)

Thorvardur Halfdanarson
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
2021-305452-P01-RST
21-008020
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Inclusion Criteria:

  • Patients aged ≥ 18 years.
  • Histologically confirmed diagnosis of unresectable, well-differentiated GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs). measurable site of disease per RECIST v1.1 (Response evaluation criteria in solid tumors) using contrast computed tomography (CT) / magnetic resonance imaging (MRI).
  • Somatostatin receptor-positive (SSTR+) disease.


Exclusion Criteria:

  • Known hypersensitivity to Lutetium 177Lu, edotreotide, DOTA (dodecane tetraacetic acid), any of the comparators, or any excipient or derivative (e.g., rapamycin).
  • Prior (Peptide Receptor Radionuclide Therapy) PRRT.
  • Any major surgery within 4 weeks prior to randomization in the trial.
  • Therapy with an investigational compound and/or medical device within 30 days or 7 half-life periods (whichever is longer) prior to randomization.
  • Other known malignancies.
  • Serious non-malignant disease.
  • Renal, hepatic, cardiovascular, or hematological organ dysfunction, potentially interfering with the safety of the trial treatments.
  • Pregnant or breastfeeding women.
  • Patients not able to declare meaningful informed consent on their own or any other vulnerable population to that sense (e.g., persons institutionalized, incarcerated etc.).

Eligibility last updated 8/13/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
I'm interested
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Location Contacts
Mayo Clinic — Rochester, MN