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)
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- Progression-free survival (PFS)
Study Overview
Brief Summary
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.
Detailed Description
The purpose of this phase III study is to evaluate the clinical benefit of liso-cel for the treatment of r/r FL by comparing it to standard of care therapy in patients with r/r FL, with progression-free survival (PFS) as the primary endpoint.
The primary objective is to demonstrate superiority of the Liso-cel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by independent review committee (IRC) based on the Lugano response criteria.
Participants randomized to Arm A (Standard of Care) will receive RCHOP, BR, or R2 based on investigator choice and this has to be determined prior to randomization.
Participants randomized to Arm B (Liso-cel treatment) will receive a single infusion CAR-positive viable T-cells.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Cyclophosphamide (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Doxorubicin (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Vincristine (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Rituximab (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Prednisone (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Bendamustine (Drug)
Arm A
Active Comparators:
R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone)
B-R (bendamustine and rituximab)
R2 (rituximab and lenalidomide)
Intervention: Lenalidomide (Drug)
Arm B
Lisocabtagene Maraleucel
Intervention: Fludarabine (Drug)
Arm B
Lisocabtagene Maraleucel
Intervention: Liso-cel (Drug)
Outcomes
Primary Outcomes
Progression-free survival (PFS)
Time Frame: Up to 5 years from the last participant randomized
Defined as the time from randomization to death due to any cause or progressive disease (PD) per independent review committee (IRC) assessment using the Lugano 2014 Criteria, whichever occurs first
Secondary Outcomes
- Complete response (CR)(Up to 5 years from the last participant randomized)
- Overall survival (OS)(Up to approximately 7 years)
- Overall response (OR)(Up to 5 years from the last participant randomized)
- Number of participants with adverse events (AEs)(Up to 5 years from the last participant randomized)
- Number of participants with adverse event of special interest (AESIs)(Up to 5 years from the last participant randomized)
- Time to next anti-cancer therapy (TTNLT)(Up to 5 years from the last participant randomized)
- PFS rate(Up to 5 years from the last participant randomized)
- EFS rate(Up to 5 years from the last participant randomized)
- OS rate(Up to approximately 7 years)
- Progression-free survival on the next line of treatment (PFS-2)(Up to 5 years from the last participant randomized)
- Duration of response (DOR)(Up to 5 years from the last participant randomized)
- Event-free survival (EFS)(Up to 5 years from the last participant randomized)
- Number of participants with serious adverse events (SAEs)(Up to 5 years from the last participant randomized)
- Number of participants with laboratory abnormalities(Up to 5 years from the last participant randomized)
- Frequency and length of hospitalizations(Up to 5 years from the last participant randomized)
- Number of participants with intensive care unit (ICU) inpatient days(Up to 5 years from the last participant randomized)
- Number of participants with non-ICU inpatient days(Up to 5 years from the last participant randomized)
- Mean change from baseline in key health-related quality of life (HRQoL) domains.(Up to 5 years from the last participant randomized)
- Time to meaningful improvement/deterioration in key HRQoL domains.(Up to 5 years from the last participant randomized)