A Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas
Status: | Recruiting |
---|---|
Conditions: | Lymphoma, Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 75 |
Updated: | 3/6/2019 |
Start Date: | November 5, 2018 |
End Date: | May 20, 2023 |
Contact: | Associate Director Clinical Trial Disclosure |
Email: | clinicaltrialdisclosure@celgene.com |
Phone: | 1-888-260-1599 |
A Global Randomized Multicenter Phase 3 Trial of JCAR017 Compared to Standard of Care in Adult Subjects With High-risk, Second-line, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM).
The study will be conducted in compliance with the International Council for Harmonisation
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with
Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and
efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as
lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm
A) or to receive JCAR017 (Arm B).
All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP,
RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT)
and Hematopoietic stem cell transplant (HSCT).
Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an
EFS event.
Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by
JCAR017 infusion.
(ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use/Good
Clinical Practice (GCP) and applicable regulatory requirements.
This is a randomized, open-label, parallel-group, multi-center trial in adult subjects with
Relapsed or refractory (R/R) aggressive Non-Hodgkin lymphoma (NHL) to compare safety and
efficacy between the standard of care (SOC) strategy versus JCAR017 (also known as
lisocabtagene maraleucel or liso-cel). Subjects will be randomized to either receive SOC (Arm
A) or to receive JCAR017 (Arm B).
All subjects randomized to Arm A will receive Standard of care (SOC) salvage therapy (R-DHAP,
RICE or R-GDP) as per physician's choice before proceeding to High dose chemotherapy (HDCT)
and Hematopoietic stem cell transplant (HSCT).
Subjects from Arm A may be allowed to cross over and receive JCAR017 upon confirmation of an
EFS event.
Subjects randomized to Arm B will receive Lymphodepleting (LD) chemotherapy followed by
JCAR017 infusion.
Inclusion Criteria:
1. Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed
consent form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
3. Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or
transformed indolent NHL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6
rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]), primary
mediastinal (thymic) large B-cell lymphoma (PMBCL), T cell/histiocyte-rich large
B-cell lymphoma (THRBCL) or follicular lymphoma grade 3B. Enough tumor material must
be available for confirmation by central pathology.
4. Refractory or relapsed within 12 months from CD20 antibody and anthracycline
containing first line therapy.
5. [18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at
screening.
6. Adequate organ function
7. Participants must agree to use effective contraception
Exclusion Criteria:
1. Subjects not eligible for hematopoietic stem cell transplantation (HSCT).
2. Subjects planned to undergo allogeneic stem cell transplantation.
3. Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus)
positive DLBCL of the elderly and Burkitt lymphoma.
4. Subjects with prior history of malignancies, other than aggressive R/R NHL, unless the
subject has been free of the disease for ≥ 2 years with the exception of the following
noninvasive malignancies:
- Basal cell carcinoma of the skin
- Squamous cell carcinoma of the skin
- Carcinoma in situ of the cervix
- Carcinoma in situ of the breast
- Incidental histologic finding of prostate cancer (T1a or T1b using the TNM
[tumor, nodes, metastasis] clinical staging system) or prostate cancer that is
curative.
- Other completely resected stage 1 solid tumor with low risk for recurrence
5. Treatment with any prior gene therapy product.
6. Subjects who have received previous CD19-targeted therapy.
7. History of or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
infection.
8. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection
(including tuberculosis) despite appropriate antibiotics or other treatment.
9. Active autoimmune disease requiring immunosuppressive therapy.
10. History of any one of the following cardiovascular conditions within the past 6 months
prior to signing the ICF: Class III or IV heart failure as defined by the New York
Heart Association (NYHA), cardiac angioplasty or stenting, myocardial infarction,
unstable angina, or other clinically significant cardiac disease.
11. History or presence of clinically relevant central nervous system (CNS) pathology
12. Pregnant or nursing (lactating) women.
We found this trial at
25
sites
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1100 Fairview Avenue North
Seattle, Washington 98109
Seattle, Washington 98109
(206) 667-5000
Fred Hutchinson Cancer Research Center At Fred Hutchinson Cancer Research Center, our interdisciplinary teams of...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
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