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MULTICENTER SINGLE-BLIND RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION FOR TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE IN PATIENTS REQUIRING HIATAL HERNIA REPAIR (TIF vs LNF)

A Study to Compare Safety and Effectiveness of Transoral Incisionless Fundoplication versus Laparoscopic Partial Fundoplication to Treat Gastroesophageal Reflux Disease Patients with Hiatal Hernia

Barham Abu Dayyeh
All
22 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
2020-300765-P01-RST
19-005226
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Inclusion Criteria:

  • 22
    •80 years of age.
  • Subjects have GERD with hiatal hernia < 5 cm, and Hill grade III or IV.
  • Pathologic reflux while off PPI based on Lyon criteria by either of the following:
    • Conclusive evidence for pathologic reflux defined as acid exposure time (AET) > 6% or LA grade C or D esophagitis;
    • Borderline evidence of pathologic reflux defined as presence of one of the following parameters: AET 4-6%, LA grade A or B, and signed informed consent.
  • Commitment to long-term study.
  • Ability to give consent individually or by a legally authorized representative.


Exclusion Criteria:

  • Hiatal hernia > 5 cm.
  • Evidence of a major motility abnormality defined by the Chicago classification version 3.0 (achalasia, absent contractility, esophagogastric junction outflow obstruction, distal esophageal spasm, or hypertensive peristalsis).
  • Pregnancy (in females) at time of procedure.
  • Previous anti-reflux procedure, have contraindications to the procedure will be excluded from participation.
  • Subjects requiring mesh treatment at time of procedure.
  • Provider discretion.
  • BMI > 35.
Procedure/Surgery
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LS1981: Phase Ib Trial of Low-Dose Selinexor (KPT-330) in Combination With Choline Salicylate (CS) for the Treatment of Patients With Non-Hodgkin Lymphoma (NHL), Hodgkin Lymphoma, Histiocytic/Dendritic Cell Neoplasms, or Multiple Myeloma

Low-Dose Selinexor and Choline Salicylate for the Treatment of Patients With Non-Hodgkin Lymphoma or Histiocytic/Dendritic Cell Neoplasms

Jonas Paludo
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
2020-300780-P01-RST
19-009349
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Inclusion Criteria:


- Biopsy-proven relapsed and/or refractory non-Hodgkin lymphoma or histiocytic/dendritic
cell neoplasms. Relapsed is defined as a relapse that occurred after having a response
to the last therapy that lasted > 26 weeks. Refractory is no response (stable disease
or progressive disease while on therapy) or relapse within 6 months. Refractoriness to
autologous stem cell transplant will be defined as disease progression within 52 weeks
following transplant.

- Most recent tumor biopsy must be < 26 weeks prior to registration

- Measurable or assessable disease: Measurable disease is defined as measurable by
computed tomography (CT) (dedicated CT or the CT portion of a positron emission
tomography [PET]/CT) or magnetic resonance imaging [MRI]: To be considered measurable,
there must be at least one lesion that has a single diameter of >= 1.5 cm. NOTE: Skin
lesions can be used if the area is >= 1.5cm in at least one diameter and photographed
with a ruler. Patients with assessable disease by PET/CT are also eligible as long as
the assessable disease is biopsy proven lymphoma

- Patients must have previously been treated with at least 2 lines of therapy

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2

- Absolute neutrophil count (ANC) >= 1,000/mm^3 (obtained =< 14 days prior to
registration)

- Platelet count >= 100,000/mm^3 (obtained =< 14 days prior to registration)

- Hemoglobin >= 8.5 g/dL (may be transfused to reach criteria) (obtained =< 14 days
prior to registration)

- Total bilirubin < 2 x upper limit of normal (ULN) (or total bilirubin =< 3.0 x ULN
with direct bilirubin =< 1.5 x ULN in patients with well-documented Gilbert's
syndrome) (obtained =< 14 days prior to registration)

- Aspartate transaminase (AST) =< 2.5 x ULN and alanine aminotransferase (ALT) =< 2.5 x
ULN (obtained =< 14 days prior to registration)

- Calculated creatinine clearance must be >= 35 ml/min using the Cockcroft Gault formula
(obtained =< 14 days prior to registration)

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

- Female of childbearing potential (FCBP*) must commit to take highly effective
contraceptive precautions** without interruption during the study and continue for at
least 12 weeks after the last dose of selinexor and CS. FCBP must refrain from
breastfeeding and donating oocytes during the course of the study. Males must use an
effective barrier method of contraception without interruption during the study and
continue for at least 12 weeks after the last dose of selinexor and CS. They must
refrain from donating sperm during the study participation.

- *FCBP defined as sexually mature women who have not undergone bilateral tubal
ligation, bilateral oophorectomy, or hysterectomy; or who have not been
postmenopausal (i.e., who have not menstruated at all) for at least 1 year

- Highly effective forms of birth control are methods that achieve a failure
rate of less than 1% per year when used consistently and correctly. Highly
effective forms of birth control include: hormonal contraceptives (oral,
injectable, patch, and intrauterine devices), male partner sterilization, or
total abstinence from heterosexual intercourse, when this is the preferred
and usual lifestyle of the patient NOTE: The double-barrier method (e.g.,
synthetic condoms, diaphragm, or cervical cap with spermicidal foam, cream,
or gel), periodic abstinence (such as calendar, symptothermal,
post-ovulation), withdrawal (coitus interruptus), lactational amenorrhea
method, and spermicide-only are not acceptable as highly effective methods
of contraception

- Provide written informed consent

- Willing to return to enrolling institution for follow-up (during the Active Monitoring
Phase of the study)

- Willingness to provide mandatory blood specimens per protocol for Pharmacokinetics
(PKs) and banking, and mandatory tissue samples for correlative research. NOTE: If an
institution is not able to provide the tissue, it does not cause the patient to be
ineligible; however, the collection of these tissues is strongly recommended


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 women

- Nursing women

- 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

- Patients known to have active hepatitis B, or C infection, or known to be positive for
hepatitis C virus (HCV) ribonucleic acid (RNA) or hepatitis B surface antigen (HBsAg)
(hepatitis B virus [HBV] surface antigen). Patients known to be human immunodeficiency
virus (HIV) positive, except those with CD4+ T-cell (CD4+) counts >= 350 cells/uL and
on an established antiretroviral therapy (ART) for at least twelve weeks and have an
HIV viral load less than 400 copies/mL prior to enrollment

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Life expectancy of < 6 months

- Active gastrointestinal (GI) dysfunction interfering with the ability to swallow
tablets, or any GI dysfunction that could interfere with absorption of study treatment

- Known intolerance to or contraindications for choline salicylate therapy. Patients
with known allergy to acetylsalicylic acid (ASA) are not eligible

- Prior exposure to a selective inhibitors of nuclear export (SINE) compound, including
selinexor

- Receiving any other investigational agent which would be considered as a treatment for
the primary neoplasm

- Active second malignancy requiring treatment that would interfere with the assessment
of the response of the lymphoma to this protocol therapy. Patients with treated
malignancies on hormonal therapy (for example breast or prostate cancer) are eligible

- History of myocardial infarction =< 6 months, or congestive heart failure requiring
use of ongoing maintenance therapy for life-threatening ventricular arrhythmias

- Radiation, chemotherapy, or immunotherapy or any other anticancer therapy =< 2 weeks
prior to registration. NOTE: Exception: patients on any BTK inhibitor (ibrutinib,
zanabrutinib, acalabrutinib, etc), or venetoclax, or corticosteroids (any dose) may
continue therapy up until the new regimen has started at investigator discretion.
After the start of protocol therapy, corticosteroids can be used at investigator's
discretion and tapered to lowest possible dose

- Active graft versus (vs.) host disease (after allogeneic stem cell transplantation) at
registration

- Major surgery (including bowel resection) =< 3 weeks prior to registration

- Must not be currently eligible or have declined high-dose therapy with autologous stem
cell transplantation rescue or chimeric antigen receptor (CAR)-T cell therapy

- Primary mediastinal (thymic) large B-cell lymphoma (PMBL)

- Known active central nervous system (CNS) lymphoma. Patients with previous CNS
involvement can enroll if the CNS component is inactive

- Patients who are on active anticoagulant therapy with direct oral anticoagulants
(DOACs), aspirin or warfarin are not eligible due to potential bleeding. EXCEPTIONS:
Patients who are on aspirin (81 mg) for primary prevention of cardiovascular disease
can enroll, but the ASA needs to be held while on this protocol therapy

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

Eligibility last updated 8/3/22. Questions regarding updates should be directed to the study team contact

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CureGN: Cure Glomerulonephropathy Network

A Registry and Biospecimen Collection to Advance the Diagnosis and Care of Patients with Glomerular Diseases

Fernando Fervenza
All
Not specified
This study is NOT accepting healthy volunteers
2020-300830-P01-RST
19-012484
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Inclusion Criteria

  • Diagnosis of MCD, FSGS, MN, or IgAN on first diagnostic kidney biopsy, per specified pathology definitions.
  • First diagnostic kidney biopsy within 5 years of study enrollment.
  • Access to first kidney biopsy report and/or slides.
  • All ages.
  • Willing to comply with study requirements, including intention to fully participate in protocol-specified follow-up at a clinical study site.
  • Informed consent and, where age appropriate, informed assent.

 Exclusion Criteria

  • ESKD, defined as chronic dialysis or kidney transplant.
  • Institutionalized.
  • Solid organ or bone marrow transplant recipient at time of first kidney biopsy.
  • Diagnosis of any of the following at the time of first diagnostic kidney biopsy:
    • Diabetes mellitus;
    • Histopathologic findings of diabetic glomerulosclerosis;
    • Systemic lupus erythematosus;
    • HIV infection;
    • Active malignancy, except for non-melanoma skin cancer;
    • Active Hepatitis B or C infection, defined as positive viral load.
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Therapeutic and Side Effects of Invasive and Noninvasive Brain Stimulation

A Study to Evaluate Therapeutic and Side Effects of Brain Stimulation

Brian Lundstrom
All
1 years to 99 years old
This study is NOT accepting healthy volunteers
2020-302381-H01-RST
19-002063
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Key Inclusion Criteria:

  • Patients that receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes and brain tumors.

Key Exclusion Criteria

  • Patients that do not receive brain stimulation for evaluation or treatment of neurological diseases including intractable epilepsy, chronic pain syndromes, and brain tumors.

     

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A071801, Phase III Trial of Post-Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared With Fractionated SRS for Resected Metastatic Brain Disease (SRS FSRS)

A Study to Compare Single Fraction Stereotactic Radiosurgery Compared with Fractionated Stereotactic Radiosurgery in Treating Patients With Resected Metastatic Brain Disease

Elizabeth Yan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100419-P01-RST
19-010587
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Inclusion Criteria:

PRE-REGISTRATION

  • Pathology from the resected brain metastasis must be consistent with a non-central nervous system primary site. Patients with or without active disease outside the nervous system are eligible (including patients with unknown primaries), as long as the pathology from the brain is consistent with a non-central nervous system primary site.
  • Three or fewer (i.e., 0 to 3) unresected brain metastases (as defined on the post operative magnetic resonance imaging [MRI]) at the time of screening.
    • Note: Dural based metastases (e.g., commonly seen in breast cancer) are eligible.
  • Unresected lesions must measure < 4.0 cm in maximal extent on the contrasted post-operative treatment MRI brain scan. The unresected lesions will be treated with SRS as outlined in the treatment section of the concept. 
    • Note: The metastases size restriction does not apply to the resected brain metastasis. 
  • One brain metastasis must be completely (gross total resection) resected ≤ 30 days prior to pre-registration. 
    • NOTE: May not have had resection of more than one brain metastasis. 
  • The resected brain metastasis must measure 2 cm or larger on the pre-operative MRI. 
  • Resection cavity must measure < 5.0 cm in maximal extent and the resection must be complete (gross total resection) on the post-operative MRI obtained ≤ 30 days prior to pre-registration. 
  • Karnofsky performance status of ≥ 60.
  • For women of childbearing potential only, a negative urine or serum pregnancy test done ≤ 7 days prior to pre-registration is required. 
  • Men and women of childbearing potential must be willing to employ adequate contraception throughout the study and for men for up to 3 months after completing treatment. 
  • A female of childbearing potential is a sexually mature female who:
    • has not undergone a hysterectomy or bilateral oophorectomy; or 
    • has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 
  • Ability to complete an MRI of the head with contrast.
  • The brain metastasis must be located > 5 mm of the optic chiasm and outside the brain stem.
  • Must be fluent in English, Spanish, or French.

REGISTRATION

  • Completion of all baseline electronic patient-reported outcome (ePRO) quality of life measures (or booklet quality of life measures) and Montreal Cognitive Assessment (MoCA).


Exclusion Criteria:

  • Must not have any prior whole brain radiation therapy.  Past radiosurgery to other lesions is allowed. 
    • NOTE: The surgically resected lesion cannot be the same location treated in the past with radiosurgery (i.e., repeat radiosurgery to the same location/lesion is not allowed on this protocol). 
  • May not have primary germ cell tumor, small cell carcinoma, or lymphoma. 
  • No evidence of leptomeningeal metastasis (LMD). 
    • NOTE: For the purposes of exclusion, LMD is a clinical diagnosis, defined as positive cerebrospinal fluid (CSF) cytology and/or equivocal radiologic or clinical evidence of leptomeningeal involvement. Patients with leptomeningeal symptoms in the setting of leptomeningeal enhancement by imaging (MRI) would be considered to have LMD even in the absence of positive CSF cytology, unless a parenchymal lesion can adequately explain the neurologic symptoms and/or signs. In contrast, an asymptomatic or minimally symptomatic patient with mild or nonspecific leptomeningeal enhancement (MRI) would not be considered to have LMD. In that patient, CSF sampling is not required to formally exclude LMD, but can be performed at the investigator's discretion based on level of clinical suspicion.

 

Other, Procedure/Surgery, Radiation
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NRG-GY018, A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

A Study to Test the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101089-P01-RST
19-007266
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Inclusion Criteria:
 

  • Women and minorities may be included.
  • Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
  • Pathology report showing results of institutional MMR IHC testing.
  • Histologic confirmation of the original primary tumor is required (submission of pathology report[s] is required). Patients with the following histologic types are eligible:
    • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.). 
  • Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
  • In patients with measurable disease (stage III and IVA), lesions will be defined and monitored by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be 15 mm in short axis when measured by CT or MRI. 
  • Patients may have received:
    • NO prior chemotherapy for treatment of endometrial cancer; OR 
    • Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed  ≥ 12 months prior to STEP 2 registration. 
  • Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, and/or intravaginal brachytherapy. All radiation therapy must be completed at least 4 weeks prior to STEP 2 registration. 
  • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to STEP 2 registration. 
  • Age ≥ 18 years.
  • Performance status of 0, 1 and 2. 
  • Hematologic Function:
    • Platelets ≥ 100,000/mcl;
    • Absolute neutrophil count (ANC) ≥ 1,500/mcl.
  • Renal Function:
    • Creatinine ≤ 1.5 x institutional/laboratory upper limit of normal (ULN).
  • Hepatic Function:
    • Total serum bilirubin level ≤ 1.5 x upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled);
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN. 
  • Thyroid stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy). 
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are eligible for this trial. 
  • For patients of child bearing potential: negative urine or serum pregnancy test within 72 hours prior to Step 2 registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. 
  • Administration of study drugs (pembrolizumab, paclitaxel, carboplatin) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from up to 14 days prior to Step 2 registration (for oral contraceptives), during treatment, and for 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either: 
    • Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy;In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR 
    • Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to Step 2 registration; OR 
    • Have a congenital or acquired condition that prevents childbearing. 
  • Patients with a prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessent of the investigational regimen are eligible for this trial
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.


Exclusion Criteria:
 

  • Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
  • Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients.
  • Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration.
  • Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration:
    • Patients who have received steroids as CT scan contrast premedication may be enrolled;
    • The use of inhaled or topical corticosteroids is allowed;
    • The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed;
    • The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step 2 registration and remain clinically stable.
  • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
  • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
  • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
  • Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
  • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated UTI), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis:
    • 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.
  • Pregnant or lactating patients.
Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Endometrial cancer, Recurrent cancer
Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Infinnium, Medical Oncology, Pembrolizumab [USAN:INN], Primary malignant neoplasm of endometrium, Recurrent malignant neoplastic disease, Reproductive system, carboplatin, paclitaxel, pembrolizumab
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S1826; A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age ≥ 12 Years) With Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

A Study to Compare Nivolumab or Brentuximab Vedotin Plus Combination Chemotherapy to Treat Patients with Newly-diagnosed Stage III-IV Classic Hodgkin Lymphoma

Stephen Ansell
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101111-P01-RST
19-009998
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Inclusion Criteria:

  • All patients must be ≥ 12 years of age.
  • All patients must have histologically confirmed newly diagnosed, previously untreated stage III or IV classical Hodgkin lymphoma (nodular sclerosing, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified [NOS]). Nodular lymphocyte predominant Hodgkin lymphoma is not eligible. 
  • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter ≥ 1.5 cm) documented on the Lymphoma Baseline Tumor Assessment Form in Rave. 
  • Patients must have a whole body or limited whole body PET-CT scan performed within 42 days prior to registration. (A contrast-enhanced [diagnostic] CT, magnetic resonance imaging [MRI] or MRI-PET is acceptable in event that PET-CT is contraindicated, however the same modality must be utilized through the trial.) NOTE: All images from PET-CT, CT, MRI or MR-PET scans performed as standard of care to assess disease (within 42 days prior to registration) must be submitted and associated radiology reports must be submitted.
  • Patients must not have received any prior chemotherapy, radiation, or antibody-based treatment for classical Hodgkin lymphoma. Steroid pre-treatment is permitted. 
  • Patients must not have had prior solid organ transplant. 
  • Patients must not have had prior allogeneic stem cell transplantation. 
  • Patients must not have received a live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, Bacillus Calmette-Guerin [BCG], oral polio vaccine, and oral typhoid).
  • At registration, investigator must declare intent-to-treat with residual PET radiation therapy (residual PET RT- RPRT) to be administered after patient completes 6 cycles of therapy if, after end of treatment, the patient meets criteria specified for receiving RT). Patients will be stratified by investigator's intent-to-treat with residual PET RT. 
  • All patients enrolled by Children's Oncology Group (COG) investigators will be considered intent-to-treat with residual PET RT. 
  • Patients must have a performance status corresponding to Zubrod scores of 0, 1 or 2. Use Lansky for patients ≤ 17 years of age. *The conversion of the Lansky to Eastern Cooperative Oncology Group (ECOG) scales is intended for National Cancer Institute (NCI) reporting purposes only. 
  • Adults (age 18 or older):
    • Creatinine clearance ≥ 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight.
    • Estimated creatinine clearance = (140
      •age) x weight in kg † 72 x creatinine* (mg/dl).
    • Multiply this number by 0.85 if the participant is a female.

† The kilogram weight is the participant weight with an upper limit of 140% of the ideal body weight (IBW).

* Actual lab serum creatinine value with a minimum of 0.7 mg/dL.

  • Pediatric Patients (age 12-17), the following must have been obtained within 14 days prior to registration:
    • Measured or calculated creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 ml/min/1.73 m^2; or 
    • Serum creatinine ≤ 1.5 x institutional upper limit of normal (IULN), or a serum creatinine (SCr) based on age/gender as follows:
    • Age < 13 maximum serum creatinine:
      • Male 1.2 mg/dL;
      • Female 1.2 mg/dL.
    • Age 13 to < 16 maximum serum creatinine:
      • Male 1.5 mg/dL;
      • Female 1.4 mg/dL.
    • Age 16-17 maximum serum creatinine:
      • Male 1.7 mg/dL;
      • Female 1.4 mg/dL.
    • Total bilirubin ≤ 2 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]).
  • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome.
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x IULN (must be documented within 28 days prior to registration for adults [age 18 or older]; must be documented within 14 days prior to registration for pediatric patients [age 12-17]). 
  • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
    • Patients must have an echocardiogram (ECHO), multigated acquisition (MUGA), or functional cardiac imaging scan with a left ventricular ejection (LVEF) fraction ≥ 50% or a shortening fraction of ≥ 27%.
  • For adults (age 18 or older), the ECHO or MUGA be performed within 42 days prior to registration.
  • For pediatric patients (age 12-17), the ECHO, MUGA, or functional cardiac imaging scan must be performed within 14 days prior to registration. 
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable or unquantifiable viral load within 6 months prior to registration are eligible for this trial.
  • Patients must not have known active hepatitis B (HBV) or hepatitis C virus (HCV) at date of registration. Patients with previously treated HBV or HCV that have an undetectable viral load and no residual hepatic impairment are eligible. 
  • Patients must not have any known central nervous system lymphoma. 
  • Patients must not have a history of or active interstitial pneumonitis or interstitial lung disease.
  • Patients must not have had a diagnosis of inherited or acquired immunodeficiency. 
  • Patients must not have any known uncontrolled intercurrent illness including, but not limited to symptomatic congestive heart failure, unstable angina pectoris, hemodynamically unstable cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 
  • Patients must not have a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to registration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued prior to cycle 1, day 1. 
  • Patients with peripheral neuropathy must have < grade 2 at date of registration. 
  • Patients must not have active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, immunosuppressive drugs, or corticosteroids with doses higher than prednisone 10 mg or equivalent). Autoimmune diseases include but are not limited to autoimmune hepatitis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), as well as symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis or glomerulonephritis). Vitiligo, alopecia, hypothyroidism on stable doses of thyroid replacement therapy, psoriasis not requiring systemic therapy within the past 2 years are permitted.
  • No second prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, any in situ cancer or other cancer for which the patient has been disease free for two years. 
  • Females of childbearing potential must not be pregnant or nursing, and have a negative pregnancy test within 28 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method while receiving study drug and for women until 6 months after receiving the last dose of study drug or, for men, until 7 months after receiving the last dose of study drug. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures. 
Biologic/Vaccine, Drug, Radiation, Other
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Electronic Validation of Online Methods to Predict and Monitor Cognitive Decline (e-VAL) (e-VAL)

Electronic Validation of Online Methods to Predict and Monitor Cognitive Decline (e-VAL)

Ronald Petersen
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122270-H01-RST
19-005653
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Inclusion Criteria:

      1. Participants will be eligible to participate provided they meet the following criteria:
        1. Adults age 55 years and older
        2. Fluent in English
        3. Able to give informed consent at baseline
        4. Access and the ability to use the internet
        5. Access to a computer either at home or wherever they have quiet, uninterrupted access to the internet
        6. Availability of an eligible study partner
      2. Study partners will be eligible to participate provided they meet the following criteria:
        1. Adults age 18 years and older
        2. Have regular and frequent interaction (in person or by telephone or online contact) with the participant
        3. Fluent in English
        4. Able to give informed consent
        5. Access and the ability to use the internet
        6. Access to a computer either at home or wherever they have quiet, uninterrupted access to the internet


Exclusion Criteria:
 

      1. Participants will be excluded from participation if any of the following are present:
        1. Unable to give consent and/or unable to consent online at baseline (determined by online screening questionnaire in the Brain Health Registry)
        2. Evidence or diagnosis of dementia – Clinical Dementia Rating (CDR) greater than 1 at baseline. Participants who transition to Dementia or become untestable while in the study will be asked to remain in the study and continue to be followed. 
        3. Evidence of acute or uncontrolled medical illness
        4. Recent history (< 6 months) of abuse or dependence of drugs and/or alcohol
      2. Participants completing the supervised portion of the study, will be excluded for any of the following:
        1. Opinion of the Investigator that the participant is otherwise unsuitable for study
      3. Additionally, at the study sites that are already collecting the CDR, the study staff will gather reasons for why participants choose to decline or are excluded from completing the eCDR, as well as track the number of participants who complete the CDR but are excluded from this study. This information will be de-identified and shared with collaborators.
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Elucidating the Relationship Between Autonomic Nervous System Regulation and Cognitive Performance

A Study to Clarify the Relationship Between Autonomic Nervous System Regulation and Cognitive Performance

David Holmes
All
18 years to 30 years old
This study is NOT accepting healthy volunteers
0000-122481-H01-RST
19-007665
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Inclusion Criteria:

  • Participants between 18-30 years of age.
  • Healthy individuals that have participated in a routine physical activity in the past 12 months. 


Exclusion Criteria:
 

  • Participants under the age of 18 or over the age of 30.
Cognitive disorder, Cognitive Disorder
Disorder of autonomic nervous system
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Clinico-Pathologic-Genetic-Imaging Studies of Neurodegenerative and Related Disorders (AND1)

A Study to Assess Imaging Studies of Neurodegenerative and Related Disorders

Keith Josephs
All
21 years and over
This study is NOT accepting healthy volunteers
0000-122713-P01-RST
19-009999
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Inclusion Criteria:

  • All subjects will be over the age of 21.
  • Must have symptoms suggestive of a neurodegenerative and/or related disorder;  i.e., patients must have one or more neurological symptom that is insidious in onset and has worsened over time in nature.

Exclusion Criteria:

  • Subjects will be excluded if they have any concurrent illnesses that could account for all of their symptoms, such as traumatic brain injury, encephalitis, strokes or developmental syndromes.
  • Women that are pregnant or post-partum and breast-feeding will be excluded.
  • All women who can become pregnant must have a pregnancy test before the PET/CT scan.
  • Subjects will be excluded if they have any of the following genetic conditions which can increase the chance of cancer:
    • Cowden disease;
    • Lynch syndrome;
    • Hypogammaglobulinemia;
    • Wiskott-Aldrich syndrome;
    • Down’s syndrome.
  • Subjects will be excluded from undergoing the MRI if it is contraindicated (metal in head, cardiac pace maker, etc), if there is severe claustrophobia, if there are conditions that may confound brain imaging studies (e.g., structural abnormalities, including subdural hematoma, intracranial neoplasm or large cortical infarcts), or if they are medically unstable or are on medications that might affect brain structure or metabolism (e.g., chemotherapy).
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Supervised Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated into the iAPS in Pregnant Patients with Type 1 Diabetes with Extension into Outpatient at Home

Evaluation of the Zone-MPC Control Algorithm Integrated into the iAPS in Pregnant Patients with Type 1 Diabetes

Yogish Kudva
Female
18 years to 45 years old
This study is NOT accepting healthy volunteers
0000-123020-P01-RST
19-012342
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Inclusion Criteria:

  • Age ≥ 18 and ≤ 45 years at the time of screening.
  • Clinical diagnosis of type 1 diabetes.
  • Currently using an insulin pump at the time of screening.
  • HbA1c ≤ 9%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit.
  • Pregnant 140/7 to 326/7 weeks gestation.
  • Singleton pregnancy without any other significant known complications, such as preeclampsia, premature rupture of membranes, 2nd/3rd trimester bleeding, fetal growth or fluid abnormalities.
  • No proven or suspected fetal malformations diagnosed in the current pregnancy.
  • Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
  • Willing to switch to Novolog or Humalog, or continue Novolog or Humalog for the duration of closed-loop use.
  • Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
  • Willing to abide by the study protocol and use study-provided devices.
  • Have a care partner with the following responsibilities: knowing subject whereabouts and being promptly available for contact by study staff during the day and night, residing in the same dwelling as subject during the night, being agreeable to all device training during the supervised HCL session and additional training on hyper- and hypoglycemia treatment, and assisting with emergency care if needed, such as transportation to the hospital or emergency department.


Exclusion Criteria:

  • Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
  • Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, Pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
  • Hemophilia or any other bleeding disorder.
  • Prior history of Preterm Premature Rupture of Membranes (PPROM).
  • Significant hyperemesis interfering with carbohydrate intake.
  • Laboratory results:
    • A1C > 9%;
    • Abnormal liver or renal function (Transaminase > 2 times the upper limit of normal, creatinine > 1.5 mg/dL);
    • Liver and renal function testing drawn at screening visit or within three months prior to screening (for other purposes) will suffice for enrollment purposes,
  • Dermatological conditions that would preclude wearing a CGM sensor or infusion site.
  • Any condition that could interfere with participating in the trial, based on investigator judgment.
  • Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
  • Having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.
  • History of severe hypoglycemia in the past 6 months.
  • History of DKA requiring hospitalization in the past 6 months.
  • Significant chronic kidney disease (eGFR < 60) or hemodialysis.
  • Significant liver disease.
  • History of adrenal insufficiency.
  • History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated.
  • History of high dose steroid use in the past 8 weeks.
Device
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A Phase I Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity o f Ascending Doses of PT0I (Pegtomarginase) in Subjects With Advanced Malignancies (PT01)

A Study to Assess the Safety and Dose Escalation of Pegtomarginase (PT01)for Subjects with Advanced Malignancies

Wen Wee Ma
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101155-P01-RST
19-009924
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Inclusion Criteria:

  • Able to understand and voluntarily sign an informed consent form (ICF).
  • Male and female adults ≥ 18 years of age at the time of informed consent 
  • Advanced solid malignancies for which no standard therapy is available. Subjects in whom available standard therapy is contraindicated may be eligible. 
  • For Dose Expansion Phase
    •Expansion Group A:
    • Histologically confirmed unresectable locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma for which no standard therapy is suitable. 
  • At least 1 measurable site of disease as defined per RECIST v1.1 criteria (Dose Expansion Phase) or evaluable disease (Dose Escalation Phase only).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
  • Life expectancy of > 12 weeks.
  • Adequate hematologic status within 28 days prior to dosing as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: 
    • Absolute neutrophil count (ANC) ≥1.5 × 109/L
    • Platelet count ≥ 100 × 10^9/L 
    • Hemoglobin ≥ 90 g/L.
  • Adequate liver function as demonstrated by:
    • Serum bilirubin < 2 × the upper limit of normal (ULN);
    • Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in subjects with liver metastases;
    • Gamma-glutamyl transferase ≤ 5 × ULN ;
    • Alkaline phosphatase ≤ 3 × ULN or ≤ 5 × ULN if bone or liver metastasis is present,
  • Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 50 mL/min according to the Cockcroft-Gault formula.
  • Prothrombin time (PT) (or International Normalized Ratio [INR]) and activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN or within the intended therapeutic range within 72 hours before the first dose of study drug in subjects receiving anticoagulant therapy.
  • Willing and able to comply with scheduled visits, treatment plan, and laboratory tests.
  • Absence of any other malignancy which has been active or treated within the past 3 years, except for cervical intraepithelial neoplasia, and nonmelanoma skin cancers (basal cell and squamous cell carcinomas).
  • Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 90 days following last dose of PT01.
  • Female subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie,by hysterectomy and/or bilateral oophorectomy) or must be using highly effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 90 days after their last dose of PT01.
  • Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 72 hours prior to the first dose.
  • Peripheral forearm veins suitable for venous access including cannulation for infusion of PT01 and multiple blood sampling


Exclusion Criteria:

  • Received prior arginase or arginine deiminase therapy.
  • Received recent anticancer therapy defined by: 
    • Chemotherapy, immunotherapy, hormonal therapy, and monoclonal antibodies (but excluding nitrosourea, mitomycin-C, targeted therapy) ≤ 28 days prior to starting study drug or who have not recovered from side effects of such therapy to Grade≤1 (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v4.03) except for subjects with alopecia; subjects receiving luteinizing hormone-releasing hormone agonists may be considered for enrollment after discussion with the Sponsor;
    • Last administration of nitrosourea or mitomycin-C ≤ 42 days prior to starting study drug or who have not recovered from the side effects of such therapy to Grade ≤ 1;
    • Targeted therapy (e.g., sunitinib, sorafenib, pazopanib) ≤ 14 days prior to starting study drug, or who have not recovered from the side effects of such therapy to Grade ≤ 1; 
    • Radiotherapy ≤ 28 days prior to starting study drug or ≤ 14 days prior to starting study drug in the case of localized radiotherapy (e.g., for analgesic purpose or for lytic lesions at risk of fracture) or who have not recovered from radiotherapy toxicities to Grade ≤ 1.
  • Undergone major surgery (e.g., intrathoracic, intraabdominal, or intrapelvic), open biopsy, or significant traumatic injury ≤ 28 days prior to starting study treatment; subjects who have had minor procedures, percutaneous biopsies, or placement of vascular access device ≤ 7 days prior to starting study drug; or subjects who have not recovered from side effects of such procedure or injury.
  • Uncontrolled concurrent illness including, but not limited to, ongoing or active serious infection requiring systemic antimicrobials (within 14 days prior to first dose), uncontrolled arterial hypertension (>160/100 mm Hg on antihypertensive medications), chronic pulmonary disease requiring oxygen, known bleeding disorders, uncontrolled endocrine diseases, altered mental status, or psychiatric illness/social situations that would limit compliance with protocol requirements.
  • Significant cardiac or pulmonary disease defined by New York Heart Association Class III or IV, history of myocardial infarction within 6 months prior starting study drug, significant unstable arrhythmia, or evidence of ischemia on ECG.
  • Symptomatic or uncontrolled brain metastases requiring current treatment (fewer than 28 days from last cranial radiation or from last steroids use).
  • Healing or open wound(s).
  • Lack of recovery of prior AEs to Grade ≤ 1 severity (except alopecia or lymphopenia) due to medications administered prior to the first dose of study drug.
  • Any other condition or finding (including social situation) that, in the opinion of the Investigator, may render the subject to be either at excessive risk for treatment complications or not able to provide evaluable outcome information.
  • Pregnant or breast-feeding women.
  • Known allergy to any of the formulation components of PT01.
Biologic/Vaccine
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Phase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor Telaglenastat (CB-839) HCl in Combination With Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma

A Study to Evaluate CB-839 HCl in Combination With Carfilzomib and Dexamethasone in Treating Patients With Recurrent or Refractory Multiple Myeloma

Wilson Gonsalves
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100861-P01-RST
19-000142
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Inclusion Criteria:
 

  • Patients must have relapsed and/or refractory myeloma and be experiencing disease relapse.
  • Patients must have measurable disease by International Myeloma Working Group (IMWG) criteria (any of the following):
    • Serum M-protein ≥ 0.5 g/dL or for IgA myeloma, an elevated IgA level by quantitative IgA nephelometry;
    • Urine M-protein ≥ 200 mg in a 24-hour collection; 
    • Serum free light chain level ≥ 10 mg/dL with an abnormal free light chain ratio;
    • Measurable plasmacytoma by cross sectional imaging (computed tomography [CT], magnetic resonance imaging [MRI] or [18F]-fluorodeoxyglucose positron emission tomography with CT [FDG PET/CT]); 
    • 20% or more light chain restricted, clonal plasma cells in the bone marrow.
  • At least two prior lines of therapy and all patients should have at least been exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky >= 60%).
  • Leukocytes ≥ 3,000/mcL.
  • Absolute neutrophil count ≥ 1,000 cells/mm3 without growth factors (within 14 days of enrollment). 
  • Hemoglobin ≥ 8 g/dL (within 14 days of enrollment)
  • Platelets ≥ 50,000 cells/mm3 (≥ 30,000 cells/mm3 if bone marrow plasma cells ≥ 50% at enrollment).
  • Total bilirubin ≤ 1.5 x 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.
  • Creatinine ≤ institutional ULN OR glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Willingness to undergo interim bone marrow biopsy/aspiration for clinical purposes.
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only. 
    • The effects of CB-839 HCl on the developing human fetus are unknown. For this reason and because carfilzomib caused embryo-fetal toxicity in pregnant rabbits at doses lower than the recommended dose, women of child-bearing potential and men must agree to use two effective methods of contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone 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 4 months after completion of CB-839 HCl, carfilzomib, and dexamethasone administration.
  • Ability to understand and the willingness to sign a written informed consent document.


Exclusion Criteria:
 

  • Patients who are refractory or intolerant to carfilzomib (prior carfilzomib exposure accepted).
  • Patients who have received recent prior chemotherapy with:
    • alkylators (e.g., melphalan, cyclophosphamide) and anthracyclines ≤ 14 days prior to registration;
    • high dose corticosteroids and immunomodulatory drugs (thalidomide or lenalidomide) ≤ 7 days prior to registration; or
    • monoclonal antibodies ≤ 14 days prior to registration.
  • Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1 except peripheral neuropathy).
  • Patients who are receiving any other investigational agents.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to CB-839 HCl (telaglenastat), carfilzomib, or dexamethasone.
  • Patients with uncontrolled intercurrent illness.
  • Any of the following: 
    • Pregnant women or women of reproductive ability who are unwilling to use two effective methods of contraception from the time of signing the informed consent form through 4 months after the last dose of study drug, nursing women, and men who are unwilling to use birth control while taking the drug and for 4 months after stopping treatment;
    • Pregnant women are excluded from this study because carfilzomib is a PI with the potential for abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with CB-839 HCl (telaglenastat), carfilzomib, and dexamethasone, breastfeeding should be discontinued if the mother is treated with this drug combination.
  • Adverse cardiac history (unstable angina, myocardial infarction less than 4 months, New York Heart Association [NYHA] class III or IV congestive heart failure [CHF], ejection fraction [EF] <40%, uncontrolled arrhythmias).
  • Concomitant high dose corticosteroids other than what is part of treatment protocol (concurrent use of corticosteroids).
    • EXCEPTION: Patients may be on chronic steroids (maximum dose 10 mg/day prednisone equivalent) if they are being given for disorders other than myeloma; e.g., adrenal insufficiency, rheumatoid arthritis, etc.
  • Central nervous system (CNS) involvement.
  • Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other AEs.
  • Concurrent amyloid light-chain (AL) amyloidosis.
  • No history of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years with the following exceptions:
    • Adequately treated in situ carcinoma of the cervix uteri or the breast;
    • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
    • Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels not receiving any current therapy; or
    • Previous malignancy with no current evidence of disease, and which was confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
  • Patient has ≥ grade 3 peripheral neuropathy or grade 2 with pain on clinical examination during the screening period.
  • Major surgery within 14 days before study registration.
  • On concurrent treatment with an HIV protease inhibitor. HIV protease inhibitors can affect the unfolded protein response in myeloma cells as well as the activity of PIs.
  • Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
  • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of CB-839 HCl (telaglenastat) including difficulty swallowing, refractory vomiting, gastric resection or bypass, or duodenal/jejunal resection.

 

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Multiple myeloma, Plasma cell disorders, Recurrent cancer
CB-839, Cancer treatment, Carfilzomib, Dexamethasone, Hematopoietic system, Immune system, Medical Oncology, Multiple myeloma, Targeted drug therapy, carfilzomib, dexamethasone
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A Single-Arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma

A Study to Evaluate Gemcitabine, Cisplatin, and Nab-Paclitaxel to Treat Patients with High-Risk Liver Bile Duct Cancer Before Surgery

Amit Mahipal
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-122154-P01-RST
19-004561
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Inclusion Criteria:

  • Diagnosis of intrahepatic cholangiocarcinoma.
  • High-quality cross-sectional imaging by computerized tomography (CT) or magnetic resonant imaging (MRI) performed within 6 weeks prior to enrollment and showed a resectable, but high-risk, IHCCA confined to the liver, bile duct, and /or regional lymph nodes. Tumors will be considered high-risk if the high-quality, contrast-enhanced CT and/or MRI +/- positron emission tomography (PET) scan showed (must meet at least one of the criteria below):
    • T-stage ≥ Ib (Ib – IV);
    • Solitary lesion > 5 cm;
    • Multifocal tumors or satellite lesions present confined to the same lobe of the liver as the dominant lesion but still technically resectable;
    • Presence of major vascular invasion but still technically resectable;
    • Suspicious or involved regional lymph nodes (N1).
  • No distant extrahepatic disease (M0).
  • Adults ≥ 18 years of age.
  • Able to give informed consent.
  • Able to adhere to study visit schedule and other protocol requirements.
  • ECOG performance status of 0-1.
  • Adequate bone marrow reserves as evidenced by:
    • ANC ≥ 1,500 cells/μl; and
    • Platelet count ≥100,000 cells/μl; and
    • Hemoglobin ≥ 9 g/dL.
  • Adequate hepatic function as evidenced by:
    • Serum total bilirubin ≤ 1.5 x ULN; and
    • AST and ALT ≤ 2.5 x ULN; and
    • Albumin ≥ 3 g/dl.
  • Adequate renal function as evidenced by:
    • Ccreatinine ≤ 1.5 x ULN.
  • Male, or a non-pregnant and non-lactating female.
  • Women of child-bearing potential (defined as a sexually mature woman who:
    • has not undergone hysterectomy [the surgical removal of the uterus] or bilateral oophorectomy [the surgical removal of both ovaries]; or 
    • has not been naturally postmenopausal for at least 24 consecutive months [i.e., has had menses at any time during the preceding 24 consecutive months]) must commit to true abstinence from heterosexual contact, or agree to use, and be able to comply with, effective contraception without interruption for 28 days prior to starting gemcitabine/cisplatin/nab- paclitaxel (including dose interruptions) until treatment with gemcitabine/cisplatin/nab-paclitaxel is complete.
  • Male subjects must practice true abstinence or agree to use a condom during sexual contact with a female of childbearing potential or a pregnant female while on treatment (including during dose interruptions) with gemcitabine/cisplatin/nab-paclitaxel and for 6 months followinggemcitabine/cisplatin/nab- paclitaxel discontinuation, even if he has undergone a successful vasectomy.


Exclusion Criteria:

  • < 18 years of age.
  • Peripheral neuropathy of grade 2 or greater by Common Terminology Criteria for Adverse Events (CTCAE) 4.0. In CTCAE version 4.0, grade 2 sensory neuropathy is defined as “moderate symptoms; limiting instrumental activities of daily living (ADLs).”
  • Concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study such as unstable angina, myocardial infarction within 6 months, unstable symptomatic arrhythmia, symptomatic congestive heart failure, uncontrolled diabetes, serious active, uncontrolled infection after inadequate biliary drainage if tumor obstructing bile duct, or psychiatric illness/social situations.
  • Pregnancy (positive pregnancy test) or lactation.
  • Known CNS disease, except for treated brain metastasis.Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed.Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician.Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded.
  • Previous (within the past 5 years) or concurrent presence of other cancer, except non-melanoma skin cancer and in situ carcinomas.
  • History of allergy or hypersensitivity to any of the study drugs.
  • Current abuse of alcohol or illicit drugs.
  • Inability or unwillingness to sign the informed consent form.
Drug
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A Phase I study of intra-arterial delivery of mesenchymal stem cells for luminal Ulcerative Colitis (MSC UC)

A Study to Evaluate Intra-arterial Delivery of Mesenchymal Stem Cells for Luminal Ulcerative Colitis

William Faubion
All
18 years to 65 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-121736-P01-RST
19-000826
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Inclusion Criteria:

  • Males and females, 18-65 years of age.
  • Moderate to Severe medically refractory inflammatory ulcerative colitis:
    • as defined by a an Adapted Mayo Score of 5 to 9 points;
    • including an endoscopic sub-score of 2 or 3.
  • Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, anti-TNF, and anti-integrin therapy are permitted.
  • To meet the definition of refractory UC, all patients must have failed at least 2 standard FDA approved medications for the treatment of UC:
    • Current standard therapy includes 5-ASA products, thiopurines, anti-TNF therapy, ustekinumab, vedolizumab, and tofacitinib (i.e., all FDA approved therapies for UC);
    • Refractory and failure to response is defined as continued symptoms despite 12 weeks of therapy at FDA approved doses by product necessitating change in medical strategy or referral for colectomy.
  • All patients should have undergone a colonoscopy in last 12 months to rule out malignant or premalignant condition.
  • Female subjects that are of child bearing potential must to agree to use effective contraception method(s) for the duration of the study.
  • Hemoglobin must be greater than 8.
  • INR must be less than 1.5.
  • Ability to comply with protocol.
  • Competent and able to provide written informed consent..


Exclusion Criteria:

  • Inability to give informed consent.
  • Clinically significant medical conditions within the six months before administration of MSC; e.g., myocardial infarction, active angina, congestive heart failure or other conditions that would, in the opinion of the investigators, compromise the safety of the patient.
  • Specific exclusions: Known history of hepatitis B, C, or HIV.
  • Patients that have had a partial colectomy.
  • Patients that have underlying vasculitis or have been diagnosed with an underlying condition that predisposes to developing blood clots.
  • History of cancer including melanoma (with the exception of localized skin cancers).
  • Investigational drug within thirty (30) days of baseline.
  • History of clinically significant auto-immunity (other than UC) or any previous example of fat-directed autoimmunity:
    • Please note that auto-immunity is defined as a systemic immune mediated disease for which the antigen is known or unknown. Autoimmune diseases other than UC are excluded. Extraintestinal manifestations of UC (specifically joint inflammation, eye inflammation, PSC, skin manifestations; i.e., pyoderma gangrenosum, erythema nodosum) will be allowable.
  • Allergic to local anesthetics.
  • Pregnant patients or trying to become pregnant or breast feeding.
  • Neoplasia of the colon and preoperative biopsy.
  • C. Difficile infection within 30 days of study injection.
  • Diagnosis of indeterminate colitis or suspicion of CD.
  • Subjects with fulminant colitis, toxic megacolon, with ostomy, or ileoanal pouch.
  • History or demonstration of pathology related to adipose tissue
  • Any other indication determined by the PI to be counter indicated for participation on this trial.
Intra-arterial infusion of therapeutic substance, Drug
Inflammatory bowel disease, Ulcerative colitis
Cellular therapy, Digestive system, Moderate chronic ulcerative colitis, Regenerative medicine therapy, Severe chronic ulcerative colitis, Stem cell therapy
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A Community-Based Prospective Cohort Study to Assess the Burden of Respiratory Syncytial Virus Infections in Older Adults in a North American Community

A Study to Assess the Burden of Respiratory Syncytial Virus Infections in Older Adults in a North American Community

Young Juhn
All
50 years and over
This study is NOT accepting healthy volunteers
0000-122113-H01-RST
19-004142
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Inclusion Criteria:

  • Southeast Minnesota (SEMN: Olmsted County and nearby counties including Dodge, Goodhue, Mower, Fillmore, Winona, and Wabasha,) residents (residency established at least one year prior to consent) aged 50 years or above at the time of consenting.
  • Those who have primary care physician at Mayo Clinic and a history of primary care visits to Mayo Clinic.
  • Those who authorizes use of their medical record for research.
  • Those who provide written consent to participate in the study.


Exclusion Criteria:
 

  • Subjects without authorization for use of medical records for research.
  • Those who do not reside in SEMN at the time of enrollment.
  • Those who may go to health care providers other than Mayo Clinic Rochester (eg, Mayo Kasson, Olmsted Medical Center).
  • (This will not be applicable to Phase II study). Those who develop ARI after October 1, 2019 but prior to enrollment and are not able to come in for enrollment and swabbing within 7 days of symptoms.
  • Those who opt out for swab test and other study procedures.
  • Those who cannot ambulate or those who are bedridden (absolute or perhaps relative contraindications to the 6 minute walk such as uncontrolled/unstable cardiovascular, pulmonary, renal, endocrine, immunological or hepatic disorders).
  • Those with known cognitive impairment.
  • Those who had evidence of an ongoing systemic bacterial, fungal, or viral infection within 7 days prior to enrollment.
  • Those who reside out of Olmsted, Dodge, Goodhue, Mower, Fillmore, Winona, and Wabasha County, MN > 2 weeks during winter season the RSV season (Oct-April) and/or > 4 weeks during summer season (May-Sep).
  • Any reason in the opinion of the study PIs that someone would not be able to complete the requirements of the study for safety or other reasons.
General infectious diseases, Respiratory syncytial virus infection
Human metapneumovirus infection, Respiratory syncytial virus infection, Respiratory system
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Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients with Ulcerative Colitis (PROPHETIC Study) (PROPHETIC Study)

Pharmacokinetics and Pharmacodynamic Biomarkers of Janus Kinase Inhibitor Therapy in Patients with Ulcerative Colitis (PROPHETIC Study)

William Faubion
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-123052-P01-RST
19-012700
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Inclusion Criteria:

  • 18 years of age or older.
  • Male or nonpregnant, nonlactating females.
  • Diagnosis of ulcerative colitis (UC) for at least 3 months prior to screening.
  • Moderately to severely active ulcerative colitis (UC) (total MCS ≥ 6), with objective evidence of inflammation defined by a Mayo endoscopic subscore (MES) ≥ 2 and disease extending > 15 cm from the anal verge.
  • Physician plans to administer Janus Kinase Inhibitor Therapy for at least 8 weeks as part of standard of care (SOC).
  • Documentation of a negative test result for latent tuberculosis within the last 12 months, or according to routine clinical practice.
  • Able to participate fully in all aspects of this clinical trial, including collection of tissue biopsies.
  • Written informed consent must be obtained and documented.


Exclusion Criteria:

  • Diagnosis of Crohn’s disease or indeterminate colitis.
  • An active, serious infection, including localized infections.
  • Concomitant administration of biological therapies for UC or potent immunosuppressants, such as azathioprine and cyclosporine. Subjects with previous exposure to these treatments should undergo an appropriate washout period according to local practice prior to starting tofacitinib, in keeping with routine clinical practice.
  • Hematology laboratory results that meet the following:
    • absolute lymphocyte count < 500 cells/mm3.
    • absolute neutrophil count < 1000 cells/mm3.
    • hemoglobin < 9 g/dL.
  • Interval between live vaccinations and initiation of tofacitinib therapy should be in accordance with current vaccination guidelines regarding immunosuppressive agents.
  • Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject’s ability to participate fully in the study.
  • Prior enrollment in the current study and having received tofacitinib.
Drug
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ARRAY 818-201, A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis (POLARIS)

A Study to Evaluate a Standard-dose and High- dose Regimen of Encorafenib + Binimetinib in Patients with BRAFV600-mutant Melanoma Brain Metastasis

Yiyi Yan
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100987-P01-RST
19-004829
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Inclusion Criteria:
 

  • Able to provide written informed consent. Adult patients under guardianship may participate if permitted by local regulations with the consent of their legally authorized guardian. All local regulations concerning patients under guardianship must be followed.
  • Age ≥ 18 years at the time of informed consent.
  • Histologically confirmed diagnosis of cutaneous melanoma with metastases to the brain.
  • Presence of BRAFV600 mutation in tumor tissue previously determined by a local PCR or NGS-based assay at any time prior to Screening or by a central laboratory during Screening.
  • Patients are required to submit archival or fresh tumor tissue and a blood sample prior to enrollment. Tissue samples will be used to determine BRAFV600-mutation status by central laboratory.
  • Must have at least 1 parenchymal brain lesion ≥ 0.5 cm and ≤ 4 cm, defined as an MRI contrast-enhancing lesion that may be accurately measured in at least 1 dimension. Note: Measurable intracranial lesions that have been previously irradiated and have not been shown to be progressing following irradiation should not be considered as target lesions.
  • Patients may have received the following prior therapies.

Safety Lead-in, Phase 2 Randomized, Phase 2 Arm A Cohort 1:

  • May have received prior local therapy for brain metastases including but not restricted to brain surgery, whole brain radiotherapy (WBRT), stereotactic radiotherapy or stereotactic radiosurgery (e.g., gamma knife, linear-accelerated-based radiosurgery, charged particles, and CyberKnife). Multiple local (brain) therapies or combinations of local therapies are allowed. For patients receiving local therapy to all brain lesions (including WBRT), progression of pre-existing lesions based on RECIST 1.1 (> 20% increase in longest diameter on baseline scan) or new measurable lesions are required. For patients receiving local therapy for some but not all lesions, disease progression based on RECIST 1.1 is not required as long as there are remaining brain lesions that are measurable and not previously treated.

Phase 2 Arm A Cohort 2:

  • Received no prior local therapy (e.g., brain surgery, craniotomy, SRS or SRT) for brain metastases;
  • All patients (Safety Lead-In and Phase 2): May have received prior immunotherapy;
  • All patients (Safety Lead-In and Phase 2): If receiving concomitant corticosteroids must be on a stable or decreasing dose (up to a total daily dose of 4 mg of dexamethasone or equivalent) for at least 2 weeks prior to first dose of study treatment.
  • An ECOG PS of 0 or 1 and Karnofsky score ≥ 80 (see Section 7.2.5).
  • Adequate bone marrow, organ function and laboratory parameters:
    • ANC ≥ 1.5 × 10^9 /L;
    • Hemoglobin ≥ 9 g/dL with or without transfusions;
    • Platelets ≥ 100 × 10^9 /L;
    • AST and ALT ≤ 2.5 × ULN; in patients with liver metastases ≤ 5 × ULN;
    • Total bilirubin ≤ 1.5 × ULN.
      • Note: Patients with documented Gilbert syndrome or hyperbilirubinemia due to non-hepatic cause (e.g., hemolysis, hematoma) may be enrolled following discussion and agreement with the Sponsor Medical Monitor.
      • Serum creatinine ≤ 1.5 × ULN; OR calculated creatinine clearance > 50 mL/min by Cockcroft-Gault formula; OR estimated glomerular filtration rate > 50 mL/min/1.73m^2.
  • Female patients of childbearing potential must have a negative serum β-HCG test result.
  • Female patients of childbearing potential must agree to protocol-approved methods of contraception and to not donate ova from Screening until 30 days after the last dose of study drug.
  • Male patients must agree to use methods of contraception that are highly effective or acceptable and to not donate sperm from Screening until 90 days after the last dose of study drug.
  • The patient is deemed by the Investigator to have the initiative and means to comply with scheduled visits, treatment plan and study procedures.


Exclusion Criteria:

  • ​​​​​​​Patients with symptomatic brain metastasis (e.g., have neurologic symptoms related to brain metastases).
  • Prophylactic or preventive anti-epileptic therapy.
    • Note: Anti-epileptic therapy indicated in order to prevent neurologic symptoms caused by a preexisting condition and not related to brain metastasis is allowed.
  • Known hypersensitivity or contraindication to any component of study treatment or their excipients.
  • Inability to swallow and retain study treatment.
  • Uveal or mucosal melanoma.
  • History of or current leptomeningeal metastases.
  • Treatment with SRS or craniotomy within 14 days prior to start of study treatment, or treatment with whole-brain radiation within 28 days prior to study treatment. Patients who received local therapy should have complete recovery with no neurological sequelae.
  • Either of the following:
    • Radiation therapy to non-brain visceral metastasis within 2 weeks prior to start of study treatment;
    • Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown).
  • Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
  • Is currently participating in a study and receiving an investigational agent; has received an investigational agent or used an investigational device within 14 days prior to start of study treatment.
  • Patients who have undergone major surgery (e.g., inpatient procedure with regional or general anesthesia) ≤ 6 weeks prior to start of study treatment. For minor surgical procedures ≤ 6 weeks prior to start of study treatment, consult the Sponsor Medical Monitor.
  • Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and patients with these may enroll.
  • Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, the following:
    • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to Screening;
    • Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
    • An LVEF < 50% as determined by MUGA or ECHO; d. Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;
    • History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia); f. Triplicate average baseline QTcF interval ≥ 480 msec.
  • Continuous or intermittent small-molecule therapeutics or investigational agents within 5 half-lives of the agent (or within 4 weeks prior to start of study treatment, when half-life is unknown). 9. Patients treated in the adjuvant setting with BRAF or MEK inhibitor(s) < 6 months prior to enrollment. Patients who received BRAF or MEK inhibitors in the metastatic setting are excluded.
  • Is currently participating in a study and receiving an investigational agent; has received an investigational agent or used an investigational device within 14 days prior to start of study treatment.
  • Patients who have undergone major surgery (e.g., inpatient procedure with regional or general anesthesia) ≤ 6 weeks prior to start of study treatment. For minor surgical procedures ≤ 6 weeks prior to start of study treatment, consult the Sponsor Medical Monitor.
  • Patient has not recovered to ≤ Grade 1 from toxic effects of prior therapy before starting study treatment. Note: Stable chronic conditions (≤ Grade 2) that are not expected to resolve (such as neuropathy, myalgia, alopecia, prior therapy-related endocrinopathies) are exceptions and patients with these may enroll.
  • Impaired cardiovascular function or clinically significant cardiovascular disease including, but not limited to, the following:
    • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting) < 6 months prior to Screening;
    • Congestive heart failure requiring treatment (New York Heart Association Grade ≥ 2);
    • An LVEF < 50% as determined by MUGA or ECHO;
    • Uncontrolled hypertension defined as persistent systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg despite current therapy;
    • History or presence of clinically significant cardiac arrhythmias (including resting bradycardia, uncontrolled atrial fibrillation or uncontrolled paroxysmal supraventricular tachycardia);
    • Triplicate average baseline QTcF interval ≥ 480 msec.
  • Other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study treatment administration or that may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient an inappropriate candidate for the study.
Drug, Administration of antineoplastic agent, Combination therapy, Drug therapy, RET proto-oncogene mutation analysis
Brain lesions, Brain metastasis, Brain tumor, Cancer, Melanoma, Skin cancer
Binimetinib [USAN:INN], Cancer treatment, Encorafenib [USAN:INN], Genetic mutation, Integumentary system, Lesion of brain, Medical Oncology, Metastatic malignant melanoma, Nervous system, Secondary malignant neoplasm of brain, Targeted drug therapy, binimetinib, encorafenib
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A Phase 2b/3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 12 Month Clinical Trial to Evaluate the Efficacy and Safety of MN-166 (Ibudilast) Followed by an Open-Label Extension Phase in Subjects With Amyotrophic Lateral Sclerosis

A Study to Evaluate MN-166 (Ibudilast) for 12 Months Followed by an Open-label Extension for 6 Months in Patients with Amyotrophic Lateral Sclerosis (ALS)

Bjorn Oskarsson
All
18 years to 80 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-122926-P01-RST
19-011368
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Inclusion Criteria:
 

  • Written or verbal informed consent is obtained.
  • Male or female subjects age 18 to 80 years, inclusive.
  • Diagnosis of familial or sporadic AL as defined by the El Escorial-Revised (2000) research diagnostic criteria for ALS [clinically definite, clinically probable, probable-laboratory supported].
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • ALS onset of ≤ 18 months from first clinical signs of weakness prior to screening.
  • If currently using riluzole, subject must be on a stable dose for at least 30 days prior to initiating study drug.
  • If currently using edaravone, subject should have completed the first 14 days of their initial treatment cycle prior to initiating study drug.
  • Documented ALS history of location of disease onset (i.e., bulbar onset, limb onset).
  • A total ALSFRS-R score of at least 35 overall at screening and:
    • No more than one of the 12 ALSFRS-R individual component items have a score of 1 or less at screening;
    • For limb onset subjects, ALSFRS-R score of ≥ 3 on item #1 (speech), #2 (salivation) and #3 (swallowing).
  • ALSFRS-R progression rate from onset of the first symptom of weakness to the ALSFRS-R score at Screening of ≥ 0.3 points and ≤ 1 point per month calculated as:
    • ALSFRS-R score at onset of first symptom of weakness (assume 48) minus ALSFRS-R score at Screening divided by number of months since onset of first symptom of weakness.
  • Documented pulmonary function test (PFT) result within the last 6 months (i.e., slow vital capacity or forced vital capacity) must be ≥ 70% of predicted. If subject does not have a documented PFT result within the last 6 months, they will be administered a PFT.
  • Female subjects of childbearing potential must use one or more effective methods of contraception throughout the entire study period and for 30 days after study drug discontinuation.
  • Male subjects agree to practice contraception (e.g., condom use and contraception by female partner) unless partner is post-menopausal or unable to conceive throughout the entire study period and for 30 days after study drug discontinuation.
  • Able to swallow study medication capsules.
  • Willing and able to comply with the protocol assessments and visits, in the opinion of the Investigator.
  • No known allergies to the study drug or its excipients.
  • At clinical sites where the pneumococcal vaccine is available and administered as standard of care, has received pneumococcal vaccine within 6 years prior to starting clinical trial.

Exclusion Criteria;

  • Confirmed hepatic insufficiency or abnormal liver function (AST and/or ALT > 3 times the upper limit of normal).
  • Currently has a clinically significant psychiatric disorder or dementia which would preclude evaluation of symptoms.
  • Has a clinically significant medical condition (other than ALS) including the following: neurological, metabolic, hepatic including clinically significant chronic hepatitis, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urological disorder, central nervous system infection or other active infection including a history of HIV (human immunodeficiency virus) that would pose a risk to the subject if they were to participate in the study or that might confound the results of the study.
  • Female subject is lactating, pregnant or planning pregnancy at Screening or Baseline.
  • History of malignancy < 5 years prior to signing the informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Resting pulse < 50 bpm, SA or AV block, uncontrolled hypertension, or repeated demonstration of a QTc interval of > 450 ms in males and > 470 ms in females.
  • Past or current use of ibudilast.
  • Current use or treated with parenteral (intravenous or intramuscular) high-dose (> 25 mg/week) vitamin B12 (i.e., methylcobalamin, hydroxylcobalamin, cyanocobalamin, adenosyl cobalamin) within 30 days prior to study drug administration.
  • History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug.
  • History of alcohol or substance abuse (DSM-5 criteria) ≤ 3 months prior to screening or alcohol or substance dependence (DSM-5 criteria) ≤ 12 months prior to screening.
  • Poor peripheral venous access that will limit the ability to draw blood as judged by the Investigator.
  • Currently participating, or has participated in, a study with an investigational or marketed compound or device within 30 days or 5 half-lives, whichever is shorter, prior to signing the informed consent.
  • Unable to cooperate with any study procedures, unlikely to adhere to the study procedures and keep appointments, in the opinion of the Investigator.
  • Use of tracheostomy or > 22/24h ventilatory support.

Eligibility last updated 10/13/21. Questions regarding updates should be directed to the study team contact.

Drug, Other
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Erector Spinae Plane Block for Rib Fractures: A Pilot Study

A Study to Evaluate Ultrasound-guided Erector Spinae Plane Blocks

Daniel Stephens
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122499-H01-RST
19-007896
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Inclusion Criteria:

  • Patients 18 years old or older.
  • Patients with one or more acute traumatic rib fractures.


Exclusion Criteria:

  • Individuals under 18 years of age.
  • Inability to position appropriately.
  • Unconscious or heavily sedated.
  • Patients who are critically ill such that care should not be delayed for regional anesthesia.
  • Vulnerable populations including prison inmates and pregnant patients.
  • Overlying skin infection, wound, or dressing/equipment (i.e., chest tube).
  • Inability to visualize target anatomy or by ultrasound or anatomy prohibitive for other reasons to perform procedure successfully.
  • Known or documented allergy to ropivacaine or other amide local anesthetic.
Care of intensive care unit patient, Emergency treatment, Ultrasonography guided erector spinae plane block, Other
Broken rib, Broken ribs, Fracture
Fracture of rib, Musculoskeletal system, Nerve block, Traumatic fracture of bone, Ultrasound-guided injection
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Isolation, Activation and Expansion of Mutation Reactive T-cells

A Study to Analyze Isolation, Activation and Expansion of Mutation Reactive T-cells

Dennis Wigle
All
18 years and over
This study is NOT accepting healthy volunteers
0000-122959-H01-RST
19-011642
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Inclusion Criteria:

  • Adults, ≥ 18 years old.
  • Adults with lung disease undergoing lung resection surgery.


Exclusion Criteria:
 

  • < 18 years old.
Cancer, Lung cancer
Cell-free DNA test, Disorder of lung, Medical Oncology, Respiratory system, Somatic mutation, Wedge resection of lung
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Toward a Learning Healthcare System for Distressed Children with Complex Disease

A Study to Develop a Learning Healthcare System for Distressed Children with Complex Disease

Sarah McCarthy
All
7 years and over
This study is NOT accepting healthy volunteers
0000-122608-H01-RST
19-008940
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Inclusion Criteria
•Patient:

  • Children aged 18 and younger at the time of consent with C-CD.
  • Actively being followed by the Mayo Clinic Complex Care Clinic (ComPACT) with at least one visit in the past year.
  • English speaking.

Inclusion Criteria
•Parent or Caregiver:

  • Parents, guardians, and caregivers of participating children with C-CD.
  • Aged 18 or older at time of consent.
  • English speaking.

Inclusion Criteria
•Clinician Stakeholder:

  • ComPACT-affiliated physicians, nurse practitioners, nurses, social workers.

 

Inclusion Criteria
•Health System Stakeholder:

 

  • Desk staff, administrators, clinical leaders, information technology staff within pediatrics or related practices.

 

Exclusion Criteria - Patient:

  • Clinical condition that would interfere with their ability to participate in an interview (e.g., severe developmental delay or other cognitive impairment).

Exclusion Criteria
•Parent or Caregiver:

  • Clinical condition that would interfere with their ability to participate in an interview (e.g., severe developmental delay or other cognitive impairment).

Exclusion Criteria
•Clinician/Health System Stakeholder:

  • None.

 

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ICP-CL-00107: A Phase I/II, Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

A Study of Tyrosine Kinase Inhibitor ICP-022 in Patients With r/r B-Cell Malignancies

Yucai Wang
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101044-P01-RST
19-011461
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Inclusion Criteria:

  • Signed Informed Consent.
  • All subjects must meet criteria for requiring therapy at time of enrollment (see treatment indications below).
  • Age ≥ 18 years.
  • Patients with histologically confirmed relapsed or refractory B-cell malignancies, including only patients with Grades 1-3a FL, MZL, MCL, and CLL/SLL.
  • Patient must had received ≥1 or ≤ 4 prior therapies with documented failure to achieve at least partial response, or disease progression after the most recent systemic treatment.
  • Patient must have ≥ 1 measurable lesion site on CT scan (nodal lesions must have an LDi > 15 mm; extranodal lesions must have an LDi > 10 mm). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead (Subjects with spleen-only disease are considered as not having measurable disease).
  • Electrocorticogram(ECOG) performance status of 0 ~1.
  • Life expectancy (in the opinion of the investigator) of ≥ 4 months.
  • Adequate liver function at time of screening: Total bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) (Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible); Aspartate aminotransferase (AST)/ Alanine Aminotransferase (ALT) ≤ 2.5 × ULN.
  • Coagulation test: at time of screening, international normalized ratio (INR) ≤ 1.5, and the activated partial thromboplastin time (APTT) ≤ 1.5× ULN.
  • Adequate hematological function at time of screening: complete blood count tests should be independent of support therapies (i.e., growth factors, or transfusion) and fulfill these criteria: neutrophil count ≥ 1.5 × 10^9 /L, platelet count ≥ 75 × 10^9/L, hemoglobin ≥ 80 g/L; if presence of bone marrow infiltration, neutrophil count ≥ 1.0 × 10^9 /L and platelet count ≥ 50× 10^9 /L.
  • Adequate renal function at time of screening: serum creatinine ≤ 1.5 × ULN or creatinine clearance by Cockcroft-Gault formula ≥ 60 mL/min.
  • Negative test results for Hepatitis B Virus(HBV) ([HBsAg (-)] and non-active HBV or Hepatitis C Virus(HCV) infection:
    • Patients who are positive for anti-Hepatitis B Virus core(anti-HBc) antibody must be negative for HBV DNA by Polymerase Chain Reaction (PCR) to be eligible for study participation;
    • Patients who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation.
  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential and who are considered to be postmenopausal (≥ 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test.
  • Patients must agree to either remain completely abstinent or to use two effective contraceptive methods that result in a failure rate of < 1 % per year from screening until (a) 1 month if the patient is a male or (b) 2 months if patient is a female after the last dose of Innocare Pharma-022(ICP-022).


Exclusion Criteria:

  • Pregnant or breast-feeding or intending to become pregnant during the study.
  • Prior treatment with systemic immunotherapeutic agents, including but not limited to cytokine therapy and anti-CTLA4, anti-Programmed death 1(anti-PD1) and anti- Programmed cell death 1 ligand 1(anti-PDL1) therapeutic antibodies, within 12 weeks or five half-lives of the drug, whichever is shorter, before first dose of ICP-022.
  • Treatment with any Bruton's tyrosine kinase inhibitor(BTKi), phosphatidylinositol 3 kinase( PI3Ki) or B-cell lymphoma-2(BCL-2) inhibitor.
  • Patients with known allergies to ICP-022 or its excipients.
  • Treatment with any chemotherapeutic agent, or treatment with any other investigational therapies including but not limited to anti-cancer agent (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks prior to first dose of ICP-022.
  • History of allogeneic stem-cell (or other organ) transplantation.
  • Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
  • Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies.
  • Concurrent use of a strong Cytochrome P450 3A (CYP3A) inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half-lives of the prohibited medication.
  • Active uncontrolled infections.
  • Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug.
  • Known infection with HIV, seropositive status.
  • Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) ≤ Grade 1, or to the levels dictated in the eligibility criteria with the exception of alopecia.
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML).
  • Medically apparent central nervous system(CNS) lymphoma or leptomeningeal disease.
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease:
    • Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, are allowed;
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, abusing of alcohol or illegal drugs including non-prescribed marijuana within last 6 months from screening.
  • Major surgery or significant traumatic injury < 28 days prior to the first dose of ICP-022 (excluding biopsies) or anticipation of the need for major surgery during study treatment.
  • Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to be of low likelihood for recurrence).
  • Significant cardiovascular disease such as New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina).
  • Significant active pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease).
  • Administration of a live, attenuated vaccine within 28 days before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
  • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment < 20 mg/day prednisone or equivalent within 7 days prior to first dose of ICP-022:
    • Inhaled and topical steroids are permitted.
  • Unable to swallow tablets or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

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MC1924: SBRT with Immunotherapy for Mesothelioma (MC1924)

SBRT with Immunotherapy for Mesothelioma

Kenneth Olivier
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-101197-P01-RST
19-012226
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of pleural mesothelioma.
  • ECOG Performance Status (PS) ≤ 2.
  • Negative pregnancy test done ≤ 14 days prior to registration, for women of childbearing potential only.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide blood samples for correlative research purposes.
  • Patient has received or is planning to receive ICI for mesothelioma.


Exclusion Criteria:

  • Pregnant women.
  • Nursing women.
Biologic/Vaccine, Radiation
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J2G-MC-JZJB A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) (J2G-MC-JZJB)

A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer

John Morris
All
12 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101059-P01-RST
19-006266
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Inclusion Criteria:

  • Are of an acceptable age to provide informed consent according to local regulations and are at least 18 years of age (patients as young as 12 years of age will be allowed if permitted by local regulatory authorities and institutional review boards).
    • All patients of 12 years of age and older, after giving assent / legally designated representative/ participant written consent.
  • Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease. Patients with mixed histology (e.g., incidental papillary thyroid cancer identified at the time of resection) are eligible if MTC is the dominant histology. Prior systemic or radiation therapy in the adjuvant setting may be allowed with discussion and approval by the Lilly medical team.
  • Radiographic progressive disease per RECIST 1.1 (Eisenhauer et al. 2009) at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Patients with measurable or non-measurable but evaluable disease are eligible; however, patients with non-measurable disease may not have disease limited to bone sites only.
  • A RET gene alteration identified in a tumor, germline DNA or blood sample (e.g., cfDNA). The RET alteration result should be generated from a laboratory with CLIA, ISO/IEC, CAP, or other similar certification. Lilly should be contacted to discuss test results from labs where such certification is not clearly demonstrated to determine eligibility; if certification is not required in the patient’s country, the Sponsor may allow enrollment using a result from a non-certified lab if sufficient evidence can be provided as to the accuracy of the result. A positive germline test for a RET mutation is acceptable given the test was determined by internal institutional quality standards and performed for clinical evaluation. In all cases, a redacted Molecular Pathology Report or other report(s) describing RET (and any co-occurring findings, if applicable) alteration analysis should be submitted to Lilly or designee during/prior to eligibility.
    • Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for retrospective central analysis of RET mutation status (for confirmation). 
  • Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al. 1982) of zero to two.
  • Ability to swallow capsules and comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
  • Patients must have discontinued from previous treatments as shown below and fully recovered.  Consult with the Lilly medical team for the appropriate length of time prior to the first dose of study treatment on additional therapies not mentioned.
  • Patients must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements.
  • Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method (for example, intrauterine device [IUD], birth control pill, or barrier method) during treatment with study drug and for 4 months following the last dose of study drug.
    • Note: Unless not allowed by local regulations, women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males unless they agree to use contraceptive method known to be highly effective. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
  • Women of childbearing potential must:
    • have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug;
    • not be breast-feeding during treatment and for at least 4 months after the last dose of study drug.
  • Capable of giving signed informed assent/consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.


Exclusion Criteria:

  • An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
  • Symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurologically stable and without increase in steroid dose for 14 days prior to the first dose of study treatment and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment, history of Torsades de pointes, or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec on more than one ECG during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the investigator’s discretion if clinically safe to do so.  Patients who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is > 450 msec.
    • Note: Patients with implanted pacemakers may enter study without meeting QTc criteria due to nonevaluable measurement if QT changes are considered monitorable;
    • Note:  Patients with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia’s and if QT changes are considered monitorable.
  • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment, a clinical diagnosis or symptoms of interstitial lung disease, or other serious medical conditions which in the medical judgment of the investigator would prevent the patient from safely participating (screening for chronic conditions is not required).
  • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
  • Uncontrolled symptomatic hyperthyroidism or hypothyroidism
  • Uncontrolled symptomatic hypercalcemia or hypocalcemia
  • Active hemorrhage or at significant risk for hemorrhage.
  • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥ 2 years previously and not currently active.  Patients receiving adjuvant hormone therapy for breast or prostate cancer with no evidence of disease are eligible. Participants with MEN2-associated pheochromocytoma are eligible if the pheochromocytoma is, in the opinion of the investigator, documented to be stable or has been resected (and patient has fully recovered from surgery).
  • Prior systemic treatment with kinase inhibitor(s)
  • Are taking a concomitant medication that is known to cause QTc prolongation.
  • Have participated, within the last 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK), in a clinical study involving an investigational product.  If the previous investigational product has a long half-life, 5 half-lives or 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK) (whichever is longer) should have passed.  Exceptions will be considered on a case by case basis by the Lilly medical team.
  • Life expectancy ≤ 3 months
  • Have a known hypersensitivity to any of the excipients of selpercatinib, cabozantinib, or vandetanib.

Eligibility last updated 10/27/21.  Questions regarding updates should be directed to the study team contact.

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19380 - An Open-Label, Multi-Institutional Pilot Study to Assess the Use of Glucarpidase in Adult Patients With Osteosarcoma Receiving High-Dose Methotrexate

Glucarpidase After High-Dose Methotrexate in Patients With Osteosarcoma

Brittany Siontis
All
25 years and over
ERROR
This study is NOT accepting healthy volunteers
0000-100828-P01-RST
19-003941
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Inclusion Criteria:

  • All races and ethnic groups will be eligible.
  • High-risk individuals aged ≥ 40 years. 
  • Eastern Cooperative Oncology Group (ECOG) performance score 0-2.
  • Participants must have pathologically confirmed diagnosis of osteosarcoma. Participants must be newly diagnosed and previously untreated, although initiation of doxorubicin/cisplatin prior to enrollment is permitted.
  • Participants must have a recommended treatment plan for their osteosarcoma that includes:
    • Planned MTX treatment at 8-12 g/m^2;
    • Absolute neutrophil count (ANC) ≥ 1,000/mm^3 (or ≥ 1.0 x 10^9/L);
    • Platelet count 75,000/mm^3 (or ≥ 75 x 10^9/L);
    • Hemoglobin ≥ 8 g/dL;
    • Serum creatinine ≤ 1.5 x the upper limit of normal (ULN), or glomerular filtration rate (GFR) ≥ 60 ml/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) formula;
    • Total serum bilirubin ≤ 2 x ULN;
    • Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤ 2.5 x ULN.
  • Participants must be willing to use appropriate contraception for the duration of study treatment and four months after completing HDMTX therapy.
  • Ability to understand and the willingness to sign a written informed consent document.


Exclusion Criteria:

  • Malignant disease, other than those being treated in this study. Exceptions to this exclusion include the following:
    • Malignancies that were treated curatively and have not recurred within 2 years after completion of treatment;
    • Completely resected basal cell and squamous cell skin cancers;
    • Any malignancy considered to be indolent and that has never required therapy;
    • Completely resected carcinoma in situ of any type.
  • Participants with rapidly progressive disease or organ dysfunction that would prevent them from receiving planned HDMTX treatment regimen.
  • Previous MTX treatment at doses >= 3 g/m^2.
  • Previous treatment with glucarpidase.
  • Known clinically significant liver disease defined as ongoing drug-induced liver injury, chronic active hepatitis C (HCV), chronic active hepatitis B (HBV), alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, portal hypertension, or history of autoimmune hepatitis.
  • Patients who have completed curative therapy for HCV are eligible.
  • Patients with known history of human immunodeficiency virus (HIV) infection are eligible.
  • Participants with a history of hypersensitivity reactions to study agent or its excipients.
  • Participants with a history of hypersensitivity to Escherichia (E).coli-derived proteins.
  • Participants with large pleural or ascitic fluid collection.
  • Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Uncontrolled intercurrent illness, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.
  • Unable or unwilling to discontinue use of agents that interact significantly with methotrexate metabolism or excretion.
Drug, Other, Administration of antineoplastic agent, Drug therapy
Bone cancer, Cancer, Osteosarcoma, Sarcoma
Cancer treatment, Medical Oncology, Methotrexate, Musculoskeletal system, Osteosarcoma of bone, gamma-Glutamyl hydrolase, glucarpidase, methotrexate
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Incidence and Psychological Impact of Vaginal Cuff Dehiscence After Different Types of Hysterectomy

A Study to Evaluate the Incidence and Psychological Impact of Vaginal Cuff Dehiscence After Different Types of Hysterectomy

Emanuel Trabuco
Female
18 years and over
This study is NOT accepting healthy volunteers
0000-121815-H01-RST
19-001563
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Inclusion Criteria:

  • Female patients, 18 years old and above.
  • Have had total vaginal or robotic/laparoscopic hysterectomy.
  • Have benign non-prolapse hysterectomy indication.
  • Have hysterectomy indication of stage I endometrial carcinoma.
  • Have had cases performed by fellowship-trained gynecologic oncologists and urogynecologists.


Exclusion Criteria:

  • Have had history of pelvic trauma or pelvic brachytherapy.
  • Have had hysterectomy for prolapse indications.
  • Have had pelvic malignancy other than stage I endometrial carcinoma
Cancer, Endometrial cancer
Dehiscence of surgical wound, Medical Oncology, Minimally invasive hysterectomy, Reproductive system, Robotic hysterectomy, Traumatic wound dehiscence, Vaginal hysterectomy
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A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential, Adaptive, Phase 3 Study with Open-label Extension Period to Assess the Efficacy and Safety of Selexipag as an Add-on to Standard of Care Therapy in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment Chronic Thromboembolic Pulmonary Hypertension (SELECT)

A Study with to Assess the Effectiveness and Safety of Selexipag as Standard-of-Care Add-on in Subjects with Inoperable or Persistent/Recurrent After-surgical Treatment CTEPH

Hilary DuBrock
All
18 years to 85 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-122993-P01-RST
19-011966
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Inclusion Criteria:

  • Signed and dated informed consent form.
  • Male and female subjects from 18 to 85 years old (inclusive).
  • With established diagnosis of inoperable CTEPH (i.e., technically non-operable) or persistent/recurrent CTEPH after pulmonary endarterectomy (PEA) and/or balloon pulmonary angioplasty (BPA), as confirmed by the corresponding adjudication committee.
  • With pulmonary hypertension (PH) in WHO FC I-IV.
  • Subject able to perform the 6-minute walk test (6MWT) with a minimum distance of 100 m and a maximum distance of 450 m at screening visit.
  • Women of childbearing potential must have a negative pregnancy test at screening and randomization and must agree to undertake monthly urine pregnancy tests, and to use a reliable method of birth control from screening visit up to at least 30 days after study treatment discontinuation. If a hormonal contraceptive is chosen it must be taken for at least 1 month prior to randomization.


Exclusion Criteria:

  • Planned or current treatment with another investigational treatment up to 3 months prior to randomization.
  • Any co-morbid condition that may influence the ability to perform a reliable and reproducible 6MWT, including use of walking aids (cane, walker, etc.).  If a patient uses a walking aid from time to time but does not have any co-morbid condition, and is able to perform a reliable and reproducible 6MWT on their own (i.e., without any walking aids), then they can be included.
  • Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation.
  • Known concomitant life-threatening disease with a life expectancy <12 months.

 

Drug, Other
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Prospective, Randomized, Controlled, Blinded Pivotal Study In Subjects Undergoing A Transforaminal Lumbar Interbody Fusion (TLIF) At One Or Two Levels Using Infuse™ Bone Graft with an Intervertebral Body Fusion Device and Posterior Supplemental Fixation For The Treatment Of Symptomatic Degenerative Disease Of The Lumbosacral Spine (TLIF)

Transforaminal Lumbar Interbody Fusion (TLIF)

Brett Freedman
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-122998-P01-RST
19-012027
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Inclusion Criteria:


A subject must meet all of the following inclusion criteria to participate in this study:

- I.1. Has degenerative disease of the lumbosacral spine in one or two adjacent levels (L2 to S1) that results in radiculopathy secondary to nerve root compression,
manifested by:

1. History of radiating leg or buttock pain, paresthesia, numbness or weakness; or
2. History of neurogenic claudication.

- I.2. Has a history of low back pain.

- I.3. Has radiographic evidence (e.g. CT, MRI, x-ray, etc.) of degenerative lumbosacral disease including at least one of the following:

1. Instability up to and including Grade 2 spondylolisthesis/retrolisthesis based on
the Meyerding classification (Meyerding, HW, 1932), or lateral listhesis demonstrated by coronal plane translation (slippage) of the superior (cranial) vertebral body lateral to the inferior (caudal) vertebral body less than or equal
to 3mm, or

2. Stenosis, or narrowing, of the lumbar spinal canal and/or intervertebral foramen requiring significant decompression leading to segmental instability, or

3. Recurrent disc herniation

- I.4. Has preoperative Oswestry Disability Index score ≥ 35.

Has to meet either inclusion criteria 5 or 6 to qualify for the study:

- I.5. Has preoperative back and leg pain scores of (back pain ≥ 4 and leg pain ≥ 1) based on the Preoperative Back and Leg Pain Questionnaire.

- I.6. Has preoperative back and leg pain scores of (back pain ≥ 1 and leg pain ≥ 4) based on the Preoperative Back and Leg Pain Questionnaire.

- I.7. Is at least 18 years of age and skeletally mature at the time of surgery.

- I.8. Has not responded to non-operative treatment (e.g., bed rest, physical therapy, medications, spinal injections, manipulation, and/or TENS) for a period of six months.

- I.9. Is willing and able to comply with the study plan and able to understand and sign the subject Informed Consent Form.


Exclusion Criteria:


A subject will be excluded from participating in this study for any of the following reasons:

- E.1 Prior surgical procedure at the involved or adjacent spinal levels (e.g. fusion, arthroplasty, and/or other non-fusion procedures). Prior discectomy and/or laminectomy
at the target or adjacent levels is allowed.

- E.2 Significant lumbar instability defined as sagittal listhesis greater than Grade 2 at any involved level using the Meyerding Classification or lateral listhesis greater
than 3 mm at any involved level.

- E.3 Planned use of an internal or external bone growth stimulator.

- E.4 Lumbar scoliosis >30 degrees.

- E.5 Patients who had a previous diagnosis of osteoporosis with a T-score of -2.5 or below in the last 12 months existing together with a prevalent fragility fracture. (If subject has a prevalent fragility fracture and a T-score hasn't been assessed in the last 12 months, a DEXA will need to be obtained.)

- E.6 Morbidly obese, as defined by a Body Mass Index (BMI) >40.

- E.7 Presence of active malignancy or prior history of malignancy (non-invasive basal cell carcinoma of the skin and non-invasive squamous cell carcinoma localized only to
the skin is allowed).

- E.8 Overt or active bacterial infection, either local to surgical space or systemic.

- E.9 Has undergone administration of any type of corticosteroid, antineoplastic, immunostimulating, or immunosuppressive agents, or medications known to inhibit the healing of bone or soft tissue within 30 days prior to implantation of the assigned treatment.

- This includes patients ≥ 65 years of age taking warfarin with documented diagnosed osteoporosis. All other patients taking warfarin should washout for at least 5 days prior to treatment

- Use of steroidal inhalers is allowed pre- and post-operatively

- Short-term steroidal use (e.g., Medrol Dosepak) is allowed pre and post-operatively. For this clinical study, short-term use is defined as ≤ two weeks. Use of steroids for longer than two weeks post-operatively through the 24-month follow-up visit is prohibited.

- E.10 Co-morbidities, which in the investigator's opinion, precludes the subject from being a surgical candidate.

- E.11 Autoimmune disease, which in the investigator's opinion, is known to affect bone metabolism or the spine (e.g., spondyloarthropathies, juvenile arthritis, rheumatoid
arthritis, Graves' disease, Hashimoto's thyroiditis).

- E.12 Any endocrine or metabolic disorder, which in the investigator's opinion, is known to affect osteogenesis (e.g., Paget's disease, renal osteodystrophy, Ehlers-Danlos syndrome, or osteogenesis imperfecta).

- E.13 Known exposure to any recombinant proteins used for bone formation (e.g., Infuse? Bone Graft, OP-1 Putty, OP-1 Implant, AUGMENT Bone Graft, GEM21S, i-FACTOR Peptide Enhanced Bone Graft, or PepGen P-15 Synthetic Bone Graft).

- E.14 Known hypersensitivity or allergy to any components of the study treatments including, but not limited to bone morphogenetic proteins (BMPs); injectable collagen;
protein pharmaceuticals (e.g., monoclonal antibodies or gamma globulins); bovine collagen products; and/or instrumentation materials (e.g., titanium, titanium alloy,
cobalt chrome, cobalt chrome alloy, or PEEK).

- E.15 History of any allergy resulting in anaphylaxis.

- E.16 Is a prisoner.

- E.17 Is mentally incompetent. If questionable, obtain psychiatric consult.

- E.18 Treatment with an investigational therapy (drug, device, and/or biologic) targeting spinal conditions within 3 months prior to implantation surgery, treatment with any other investigational therapies within 30 days prior to implantation surgery, or such treatment is planned during the 24-month period following implantation of the study treatment.

- E.19 Pregnant or nursing. Females of child-bearing potential must agree not to become pregnant for 24 months following surgery.

- E.20 A documented diagnosis of substance use disorder as defined by the DSM-5.22 (Nicotine use is allowed.)

- E.21 Pursuing worker's compensation or active litigation for spinal fusion procedure.

- E.22 Any condition, which in the investigator's opinion, would interfere with the subject's ability to comply with study instructions, which might confound data
interpretation. 

Eligibility last updated 7/27/23. Questions regarding updates should be directed to the study team contact.

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A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors (FREEDOM-1)

A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (FREEDOM-1)

Mark Stegall
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-122826-P01-RST
19-010333
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Inclusion Criteria:

  • Written informed consent must be obtained, from recipients and donors, before any assessment is performed on the respective subject.
  • Recipient age ≥ 18 years.
  • Donor age ≥ 18 and ≤ 60 years.
  • Recipients of a first kidney transplant from a living unrelated or non-HLA identical living related donor.
  • Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and meets all local standard eligibility criteria to donate stem cells for allogeneic transplantation.
  • Donor and Recipient: COVID-19 nucleic acid test (NAT) (e.g., SARS-CoV-2 RT-PCR) negative.
  • Must be willing and able to comply with protocol-required visit schedule and visit requirements.

Exclusion Criteria
•Recipient and Donor:

  • Recipient or donor with use of other investigational drugs within 30 days (or within 5 drug half-lives) of signing informed consent.
  • Recipient or donor with history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
  • Recipient and donor who are identical twins.
  • Recipient or donor who is a pregnant or nursing (lactating) woman.
  • Recipient or donor with history of malignancy or premalignant syndrome (e.g., myelodysplastic syndrome) of any organ system (other than localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
  • Recipient or donor with known bone marrow aplasia.

Exclusion Criteria
•Recipient only:

  • Multi-organ or cell transplant recipient.
  • Panel reactive antibodies (calculated panel reactive antibody > 20% by Flow/Luminex).
  • Recipient is blood type ABO incompatible or has positive crossmatch (Flow/Luminex) vs. donor.
  • Presence of donor-specific antibodies (DSA) at any time pre-transplant.
  • Recipient who is human immunodeficiency virus (HIV) hepatitis B surface antigen (HBsAg) or hepatitis c virus (HCV) positive. Recipients with history of HCV infection may participate if there is a documented history of treatment with an antiHCV agent and either one (1) negative polymerase chain reaction (PCR) at least three (3) months after last dose of treatment, or two (2) negative PCRs at least 2 weeks apart over a maximum of 4 weeks.
  • Recipient with systemic infection, current or within the 2 weeks prior to conditioning; or history of recurrent infection (e.g., polycystic liver/kidney disease, unless native kidneys removed at time of transplant).
  • Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (e.g., autoimmune disease, asthma) throughout the course of the study.
  • Recipient who had a live attenuated vaccine administered within 2 months of planned transplant surgery.
  • Recipient with a body mass index (BMI) < 18 or > 35 kg/m^2 .
  • Recipient requiring systemic anticoagulation; e.g., for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation, that cannot be temporarily interrupted which would preclude renal biopsy.
  • Recipient with contraindication to total body irradiation (TBI) according to local radiologist; e.g., previous radiation therapy at a dose which would preclude TBI, inadequate pulmonary function.
  • Recipient with autologous or allogeneic hematopoietic progenitor cell transplant prior to signing informed consent.
  • All recipient women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to using highly effective methods of contraception during dosing of study treatment. For FCR-R WOCBP who have completely discontinued mycophenolate, contraception may be discontinued after Month 36 provided no mycophenolate is restarted. WOCBP assigned as FCR-D must maintain highly effective contraception from the time of assignment to FCR001 through 1 month after the end of the mobilization period. Highly effective contraception methods include:
    • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e,g,, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or tubal ligation at least 6 weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment;
    • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject;
    • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception.
  • In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before entering study screening.
  • Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to study screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she considered not of childbearing potential.
  • Sexually active male CTR-R must use a condom during intercourse throughout the study and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of drugs via seminal fluid. For FCR-R this requirement may be lifted at 6 weeks after MMF and tacrolimus have been discontinued.

Donor-only


Exclusion Criteria:

  • Multi-organ or cell transplant recipient.
  • Panel reactive antibodies (calculated panel reactive antibody > 20% by Flow/Luminex).
  • Recipient is blood type ABO incompatible or has positive crossmatch (Flow/Luminex) vs. donor.
  • Presence of donor-specific antibodies (DSA) (positive result) at any time pretransplant.
  • Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) positive. Recipients with history of HCV infection may participate if there is a documented history of treatment with an anti-HCV agent and have either one (1) documented negative polymerase chain reaction (PCR) at least three (3) months after last dose of treatment, or two (2) documented negative PCRs at least 2 weeks apart over a maximum of 4 weeks.
  • Recipient with systemic infection, current or within the 2 weeks prior to conditioning; or history of recurrent infection (e.g., polycystic liver/kidney disease, unless native kidneys removed at time of transplant).
  • Recipient with any baseline condition requiring or anticipated will require chronic or intermittent use of systemic steroids or other IS (e.g., autoimmune disease, asthma) throughout the course of the study.
  • Recipient who had a live attenuated vaccine administered within 2 months of planned transplant surgery.
  • Recipient with a body mass index (BMI) < 18 or > 35 kg/m^2.
  • Recipient requiring systemic anticoagulation (e.g., for hyper-coagulation disorders, deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted which would preclude renal biopsy.
  • Recipient with contraindication to total body irradiation (TBI) according to local radiologist; e.g., previous radiation therapy at a dose which would preclude TBI, inadequate pulmonary function.
  • Recipient with autologous or allogeneic hematopoietic progenitor or mesenchymal stem cell transplant prior to signing informed consent.
  • All recipient women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, who do not agree to using highly effective methods of contraception during dosing of study treatment. For FCR-R WOCBP who have completely discontinued mycophenolate, contraception may be discontinued after Month 36 provided no mycophenolate is restarted. WOCBP assigned as FCR-D must maintain highly effective contraception from the time of assignment to FCR001 through 1 month after the end of the mobilization period. Highly effective contraception methods include:
    • Total abstinence (when this is in line with the preferred and usual lifestyle of the subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
    • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment;
    • Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject;
    • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system or other forms of hormonal contraception that have comparable efficacy (failure rate < 1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before entering study screening. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age-appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks prior to study screening. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of childbearing potential.
  • Sexually active male CTR-R must use a condom during intercourse throughout the study and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of drugs via seminal fluid. For FCR-R this requirement may be lifted at 6 weeks after MMF and tacrolimus have been discontinued.

Exclusion Criteria
•Donor only:

  • Biologically unrelated female donor transplant to male recipient.
  • Donor tested positive for Zika virus (ZIKV) infection. Zika infection is excluded by negative nucleic acid testing result on either serum or urine PLUS a negative Zika IgM. Only donors with the following risk factors must be tested:
    • Medical diagnosis of ZIKV in the past 6 months;
    • Residence in, or travel to, an area with an increased risk for ZIKV transmission within the past 6 months;
    • Sex within the past 6 months with a person who has either of the risk factors listed in items (a) or (b), above.

Eligibility last updated10/4/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug therapy, Live donor renal transplant, Mycophenolate therapy, Tacrolimus therapy
Cellular therapy, History of renal transplant, Immunosuppressive drug therapy, Kidney transplant, Living donor kidney transplant, Living-donor transplant, Mycophenolic acid, Stem cell therapy, Tacrolimus, Transplanted kidney present, mycophenolate, mycophenolic acid, tacrolimus
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Location Contacts
Mayo Clinic — Rochester, MN