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

Titre officiel

A Global Randomized Multicentre 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).

Sommaire:

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-centre 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.

Description de l'essai

Primary Outcome:

• Event-free survival (EFS)

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

Voir cet essai sur ClinicalTrials.gov