Clinical trial NCT06313996: A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Relapsed or Refractory Follicular Lymphoma
Keywords: Lisocabtagene Maraleucel
Liso-cel
Follicular Lymphoma
Lead sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Sponsor class: INDUSTRY
Collaborators: name: Celgene Corporation
First posted: 2024-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to 5 years from the last participant randomized
Secondary outcomes:
measure: Complete response (CR)
timeFrame: Up to 5 years from the last participant randomized
measure: Overall survival (OS)
timeFrame: Up to approximately 7 years
measure: Overall response (OR)
timeFrame: Up to 5 years from the last participant randomized
measure: Duration of response (DOR)
timeFrame: Up to 5 years from the last participant randomized
measure: Event-free survival (EFS)
timeFrame: Up to 5 years from the last participant randomized
measure: Time to next anti-cancer therapy (TTNLT)
timeFrame: Up to 5 years from the last participant randomized
measure: PFS rate
timeFrame: Up to 5 years from the last participant randomized
measure: EFS rate
timeFrame: Up to 5 years from the last participant randomized
measure: OS rate
timeFrame: Up to approximately 7 years
measure: Progression-free survival on the next line of treatment (PFS-2)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with adverse event of special interest (AESIs)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with laboratory abnormalities
timeFrame: Up to 5 years from the last participant randomized
measure: Frequency and length of hospitalizations
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with intensive care unit (ICU) inpatient days
timeFrame: Up to 5 years from the last participant randomized
measure: Number of participants with non-ICU inpatient days
timeFrame: Up to 5 years from the last participant randomized
measure: Mean change from baseline in key health-related quality of life (HRQoL) domains.
timeFrame: Up to 5 years from the last participant randomized
measure: Time to meaningful improvement/deterioration in key HRQoL domains.
timeFrame: Up to 5 years from the last participant randomized
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: