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:

Active, not recruiting

Sponsor:

Celgene

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There are 53 Locations for this study

See Locations Near You

Mayo Clinic Hospital
Phoenix Arizona, 85054, United States
HonorHealth
Scottsdale Arizona, 85258, United States
University of California San Francisco
San Francisco California, 94143, United States
Local Institution - 106
Aurora Colorado, 80045, United States
University of Colorado Cancer Center
Aurora Colorado, 80045, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Emory University
Atlanta Georgia, 30322, United States
Local Institution - 107
Atlanta Georgia, 30342, United States
Northside Hospital
Atlanta Georgia, 30342, United States
Northwestern University-Feinberg School of Medicine
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
Massachusetts General Hospital / Dana-Farber Cancer Institute
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Barbara Ann Karmanos Cancer Center
Detroit Michigan, 48201, United States
Local Institution - 119
Detroit Michigan, 48201, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Local Institution - 103
Rochester Minnesota, 55905, United States
Mayo Clinic - Rochester
Rochester Minnesota, 55905, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Local Institution - 121
Hackensack New Jersey, 07601, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Local Institution - 125
Charlotte North Carolina, 28204, United States
University of Oklahoma Peggy and Charles Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
Oregon Health and Science University
Portland Oregon, 97239, United States
Hillman Cancer Institute at UPMC
Pittsburgh Pennsylvania, 15232, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
The University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Virginia Commonwealth University
Richmond Virginia, 23298, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Local Institution - 350
Gent , 9000, Belgium
University Hospital Ghent
Ghent , 9000, Belgium
CHRU-Hopital Claude Huriez
Lille , 59037, France
Institut Paoli Calmette Hematologie
Marseille cedex , 13273, France
Centre Hospitalier Lyon Sud
Pierre Benite , 69495, France
Gustave Roussy
Villejuif CEDEX , 94805, France
Local Institution - 455
Dresden Saxony, 01307, Germany
Local Institution - 451
Berlin , 13125, Germany
Robert-Rössle-Klinik im HELIOS Klinikum Berlin-Buch Klinik für Hämatologie, Onkologie u. Tumorimmuno
Berlin , 13125, Germany
Universitaetsklinikum Carl Gustav Carus
Dresden , 01307, Germany
Universitaetsklinik Hamburg - Eppendorf
Hamburg , 20246, Germany
Universitat zu Koln
Köln , 50937, Germany
Universitatsklinik Muenster
Muenster , 48149, Germany
LMU Klinikum der Universitat
München , 81377, Germany
La Sapienza, University of Rome
Rome , 00161, Italy
Istituto Clinico Humanitas
Rozzano (MI) , 20089, Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino
Torino , 10126, Italy
Local Institution - 203
Osaka Osaka-shi, 545-8, Japan
Local Institution - 200
Chuo-ku Tokyo, 104-0, Japan
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
Bunkyo-ku , 113-8, Japan
National Cancer Center Hospital
Chuo-ku , 104-0, Japan
Toranomon Hospital
Minato-ku , 105-8, Japan
Osaka City University Hospital
Osaka , 545-8, Japan
Erasmus Medical Center-Daniel den Hoed
Rotterdam , 3075 , Netherlands
Local Institution - 550
Rotterdam , 3075 , Netherlands
Hospital Clinic i Provincial de Barcelona - ICMHO
Barcelona , 08036, Spain
Hospital Universitario 12 de Octubre
Madrid , 28041, Spain
Karolinska Universitetssjukhuset - Huddinge
Stockholm , SE-14, Sweden
Inselspital Bern
Bern , CH-30, Switzerland
University College Hospital Macmillan Cancer Centre
London , WC1E , United Kingdom
Local Institution - 751
Southampton , SO16 , United Kingdom
University Hospital Southampton NHS Foundation Trust - Southampton General Hospital
Southampton , SO16 , 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:

Active, not recruiting

Sponsor:


Celgene

How clear is this clinincal trial information?

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