Clinical trial · Interventional
A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
A Global Randomized Multicenter Phase 3 Trial to Compare the Efficacy and Safety of Lisocabtagene Maraleucel (JCAR017/BMS-986387) to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma (TRANSFORM FL)
NCT06313996CI-TRIAL-00105914withdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Replaced with another clinical trial.
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the efficacy and safety of Liso-cel compared to standard of care in adults with Relapsed or Refractory Follicular Lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bendamustine | Drug | Bendamustine | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Liso-cel | Drug | — | UNRESOLVED |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm A
- description
- Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
- interventionNames
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Rituximab
- Drug: Prednisone
- Drug: Bendamustine
- Drug: Lenalidomide
- type
- EXPERIMENTAL
- label
- Arm B
- description
- Lisocabtagene Maraleucel
- interventionNames
- Drug: Fludarabine
- Drug: Liso-cel
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria * Participants must have measurable disease. * Participants must have previously been treated with certain defined anti-cancer therapies and their disease must have come back or must have not responded to the previous or last treatment. * Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Participants that have histologically confirmed Follicular Lymphoma (FL) (Grade 1, 2, or 3a) corresponding to the most recent relapse prior to screening. * Participants that have Relapsed or refractory FL, as assessed by the Investigator. * Participants that have received at least one prior line and no more than three prior lines of systemic therapy including a combination of an anti-CD20 antibody and an alkylating agent. * Participants that received one prior line of systemic therapy are eligible if they present with high risk features. Exclusion Criteria * Participants must not have any history of heart problems. * Participants must not have any bleeding disorders. * Participants must not have any Central Nervous System involvement by Follicular Lymphoma or other brain conditions. * Other protocol-defined Inclusion/Exclusion criteria apply.
References
Publications (0)
Data not yet available
No reference posted for this study.