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
a study on Lymphoma Non Hodgkin Lymphoma
Summary
- Eligibility
- for people ages 18-75 (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
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.
Official Title
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).
Keywords
Lymphoma, Non-Hodgkin Non-Hodgkin Lymphomas DLBCL Efficacy Safety JCAR017 Liso-cel High-Risk Relapsed Refractory Lymphoma Lymphoma, B-Cell Standard of Care
Eligibility
You can join if…
Open to people ages 18-75
- 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 ≤ 2.
- Histologically proven diffuse large B-cell lymphoma (DLBCL) NOS (de novo or transformed FL), high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma [DHL/THL]) 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.
- Adequate organ function
- Participants must agree to use effective contraception
You CAN'T join if...
- Subjects not eligible for hematopoietic stem cell transplantation (HSCT).
- Subjects planned to undergo allogeneic stem cell transplantation.
- Subjects with T cell rich/histiocyte rich large B-cell lymphoma (THRBCL), primary cutaneous large B-cell lymphoma, primary mediastinal B-cell lymphoma (PMBCL), EBV(Epstein-Barr virus) positive DLBCL of the elderly and Burkitt lymphoma, transformed indolent NHL except transformed FL.
- 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.
- History of or active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)infection.
- 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.
Locations
- University of California San Francisco not yet accepting patients
San Francisco California 94143 United States - Mayo Clinic Arizona not yet accepting patients
Scottsdale Arizona 85259 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Celgene
- ID
- NCT03575351
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated
Frequently Asked Questions
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
Thank you!
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03575351.