NCT06313996WithdrawnPhase 3
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)
Source: ClinicalTrials.gov · Last updated 18 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 26 Feb 2024
- Start date
- 29 Mar 2024
- Primary completion date
- 16 Oct 2031
- Lead sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- Diseases
- Follicular lymphoma
- NCT number
- NCT06313996
- EudraCT number
- 2023-507477-18
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.