At a glance
ClinicalIndex Comparison Record- ✓Age 18-75 years at time of informed consent
- ✓ECOG performance status ≤1
- ✓Histologically confirmed DLBCL NOS, double/triple-hit lymphoma with DLBCL histology, PMBCL, THRBCL, or follicular lymphoma grade 3B with adequate tumor material for central pathology review
- ✓Refractory or relapsed within 12 months from first-line CD20 antibody and anthracycline-containing therapy
- ✕Not eligible for hematopoietic stem cell transplantation (HSCT)
- ✕Planned allogeneic stem cell transplantation
- ✕Primary cutaneous large B-cell lymphoma, EBV-positive DLBCL, Burkitt lymphoma, or Richter transformation
- ✕Prior history of malignancies other than aggressive R/R NHL, unless disease-free for ≥2 years (except specified noninvasive malignancies)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 3 clinical trial evaluating Standard of Care and JCAR017 for Lymphoma, Non-Hodgkin. Completed, enrolled 184 participants across 54 sites in 12 countries.
Detailed 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.
Study Details
Timeline
Interventions
Standard of Care
JCAR017