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

The requested reference [13cb904dc562a5dfb008e961f85b96bfe9ae805a] no longer exists in our database. It has been replaced by the current reference: [c67c4d86e023960b324671a7c74a9a936bb57ef4]

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2018
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.
Epistemonikos ID: f95948c5ec5c205f5f74e002f75bf1139d4be204
First added on: May 21, 2024