A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
- Conditions
- Relapsed or Refractory Follicular Lymphoma
- Interventions
- Registration Number
- NCT06313996
- Lead Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A Doxorubicin Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm A Vincristine Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm A Bendamustine Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm A Lenalidomide Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm A Rituximab Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm A Prednisone Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide) Arm B Fludarabine Lisocabtagene Maraleucel Arm B Liso-cel Lisocabtagene Maraleucel Arm A Cyclophosphamide Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) 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 Outcome Measures
Name Time Method Complete response (CR) Up to 5 years from the last participant randomized Defined as participants achieving a complete response per IRC assessment using the Lugano 2014 Criteria
Overall survival (OS) Up to approximately 7 years Defined as the time from randomization to death due to any cause
Overall response (OR) Up to 5 years from the last participant randomized Defined as participants achieving a response (CR or partial response (PR)) per IRC assessment using the Lugano 2014 Criteria
Time to next anti-cancer therapy (TTNLT) Up to 5 years from the last participant randomized Defined as time from randomization to start of new anti-cancer therapy or death due to any cause, whichever occurs first
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 Defined as the time from randomization to death from any cause or tumor progression on next line treatment per Investigator assessment, whichever occurs first
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 Duration of response (DOR) Up to 5 years from the last participant randomized Defined as the time from first response (CR or PR) per IRC assessment using the Lugano 2014 Criteria to PD or death due to any cause, whichever occurs first
Event-free survival (EFS) Up to 5 years from the last participant randomized Defined as the time from randomization to the first documentation of progressive disease (PD) per IRC assessed using the Lugano 2014 Criteria start of new anti-cancer therapy, or death due to any cause, whichever occurs first
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 Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)Time to meaningful improvement/deterioration in key HRQoL domains. Up to 5 years from the last participant randomized Key HRQoL Domains:
Global health status/quality of life (GHS/QoL), fatigue, pain, physical functioning, role functioning, cognitive functioning from The European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ C30), and Symptom Burden and Physical Condition/Fatigue from the European Quality of Life Module Non-Hodgkin's Lymphoma Low-Grade 20 items (EORTC QLQ-NHL-LG20)