Non Hodgkin Lymphoma Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Subject is ≥ 18 years and ≤ 75 years of age at the time of signing the informed consent form (ICF).
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
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.
Refractory or relapsed within 12 months from CD20 antibody and anthracycline containing first line therapy.
[18F] fluorodeoxyglucose (FDG) positron emission tomography (PET) positive lesion at screening. (Deauville score 4 or 5)
Adequate organ function
Participants must agree to use effective contraception

Exclusion Criteria:

Subjects not eligible for hematopoietic stem cell transplantation (HSCT).
Subjects planned to undergo allogeneic stem cell transplantation.
Subjects with, primary cutaneous large B-cell lymphoma, EBV (Epstein-Barr virus) positive DLBCL, Burkitt lymphoma or transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma (Richter transformation).

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
Treatment with any prior gene therapy product.
Subjects who have received previous CD19-targeted therapy.
Subjects with active hepatitis B, or active hepatitis C are excluded. Subjects with negative polymerase chain reaction (PCR) assay for viral load for hepatitis B or C are permitted. Subjects positive for hepatitis B surface antigen and/or anti-hepatitis B core antibody with negative viral load are eligible and should be considered for prophylactic antiviral therapy. Subjects with a history of or active human immunodeficiency virus (HIV) are excluded.
Subjects with uncontrolled systemic fungal, bacterial, viral or other infection (including tuberculosis) despite appropriate antibiotics or other treatment.
Active autoimmune disease requiring immunosuppressive therapy.
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.
History or presence of clinically relevant central nervous system (CNS) pathology
Pregnant or nursing (lactating) women.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

184

Study ID:

NCT03575351

Recruitment Status:

Completed

Sponsor:

Celgene

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There are 54 Locations for this study

See Locations Near You

Local Institution - 129
Scottsdale Arizona, 85258, United States
Local Institution - 116
Scottsdale Arizona, 85259, United States
Local Institution - 115
San Francisco California, 94143, United States
Local Institution - 106
Aurora Colorado, 80045, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Local Institution - 126
Tampa Florida, 33612, United States
Local Institution - 108
Atlanta Georgia, 30322, United States
Local Institution - 107
Atlanta Georgia, 30342, United States
Local Institution - 122
Chicago Illinois, 60611, United States
Loyola University Medical Center Cardinal Bernardin Cancer Center
Maywood Illinois, 60153, United States
Local Institution - 102
Boston Massachusetts, 02114, United States
Local Institution - 104
Boston Massachusetts, 02215, United States
Local Institution - 120
Ann Arbor Michigan, 48109, United States
Local Institution - 119
Detroit Michigan, 48201, United States
Local Institution - 112
Minneapolis Minnesota, 55455, United States
Local Institution - 103
Rochester Minnesota, 55905, United States
Local Institution - 100
Omaha Nebraska, 68198, United States
Local Institution - 121
Hackensack New Jersey, 07601, United States
Local Institution - 111
Buffalo New York, 14263, United States
Local Institution - 117
New York New York, 10065, United States
Local Institution - 125
Charlotte North Carolina, 28204, United States
Local Institution - 127
Oklahoma City Oklahoma, 73104, United States
Local Institution - 101
Portland Oregon, 97239, United States
Local Institution - 123
Pittsburgh Pennsylvania, 15232, United States
Local Institution - 109
Dallas Texas, 75246, United States
Local Institution - 124
Houston Texas, 77030, United States
Local Institution - 114
Richmond Virginia, 23298, United States
Local Institution - 110
Seattle Washington, 98109, United States
Local Institution - 350
Gent , 9000, Belgium
Local Institution - UNK 25
Helsinki , 00029, Finland
Local Institution - 401
Lille , 59037, France
Local Institution - 400
Marseille cedex , 13273, France
Local Institution - 403
Pierre Benite , 69495, France
Local Institution - 402
Villejuif CEDEX , 94805, France
Local Institution - 455
Dresden Saxony, 01307, Germany
Local Institution - 451
Berlin , 13125, Germany
Local Institution - 452
Hamburg , 20246, Germany
Local Institution - 450
Köln , 50937, Germany
Local Institution - 454
Muenster , 48149, Germany
Local Institution - 453
München , 81377, Germany
Local Institution - 500
Rome , 00161, Italy
Local Institution - 501
Rozzano (MI) , 20089, Italy
Local Institution - 502
Torino , 10126, Italy
Local Institution - 203
Osaka Osaka-shi, 545-8, Japan
Local Institution - 200
Chuo-ku Tokyo, 104-0, Japan
Local Institution - 201
Minato-ku Tokyo, 105-8, Japan
Local Institution - 202
Bunkyo-ku , 113-8, Japan
Local Institution - 550
Rotterdam , 3075 , Netherlands
Local Institution - 600
Barcelona , 08036, Spain
Local Institution - 601
Madrid , 28041, Spain
Local Institution - 650
Stockholm , SE-14, Sweden
Local Institution - 700
Bern , 3010, Switzerland
Local Institution - 751
Southampton Hampshire, SO16 , United Kingdom
Local Institution - 750
London , WC1E , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

184

Study ID:

NCT03575351

Recruitment Status:

Completed

Sponsor:


Celgene

How clear is this clinincal trial information?

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