Schéma : 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.


Study arms:
- Active Comparator: Arm A - Standard of Care (SOC)
Subjects should receive SOC (R-DHAP, R-ICE or R-GDP) followed by HDCT (BEAM) and HSCT. Standard of care regimen will be administered as per investigator decision.
Intervention: Drug: Standard of Care
- Experimental: Arm B - JCAR017
Lymphodepleting chemotherapy with intravenous (IV) fludarabine (30 mg/m2/day for 3 days) plus cyclophosphamide IV (300 mg/m2/day for 3 days) (flu/cy) concurrently followed by JCAR017 infusion.
Intervention: Genetic: JCAR017


Current primary outcome:
Event-free survival (EFS) [ Time Frame: Approximately 3 years ]
Time from randomization to death from any cause, progressive disease (PD), failure to achieve complete response (CR) or partial response (PR), or start of new antineoplastic therapy due to efficacy concerns, whichever occurs first

Current secondary outcomes:
- Complete response rate (CRR) [ Time Frame: Approximately 3 years ]
- Progression-free survival (PFS) [ Time Frame: Approximately 3 years ]
- Overall survival (OS) [ Time Frame: Approximately 4.5 years ]
- Overall response rate (ORR) [ Time Frame: Approximately 3 years ]
- Duration of response (DOR) [ Time Frame: Approximately 3 years ]
- PFS on next line of treatment (PFS-2) [ Time Frame: Approximately 3 years ]
- Adverse Events (AEs) [ Time Frame: Approximately 3 years ]
- HRQoL parameters assessed by European Organisation for Research and Treatment of Cancer - Quality of Life C30 questionnaire (EORTC-QLQ-C30) [ Time Frame: Approximately 3 years ]
- HRQoL parameters assessed by EQ-5D-5L [ Time Frame: Approximately 3 years ]
- HRQoL parameters assessed by FACT-Lym "Additional concerns" subscale [ Time Frame: Approximately 3 years ]
- Reasons for hospital resource utilization [ Time Frame: Approximately 3 years ]
- Rate of hematopoietic stem cell transplant (HSCT) [ Time Frame: Approximately 3 years ]
- Frequency of hospital resource utilization [ Time Frame: Approximately 3 years ]
- Hospital resource utilization (HRU) [ Time Frame: Approximately 3 years ]