Relapsed or Refractory Follicular Lymphoma
Conditions
Keywords
Lisocabtagene Maraleucel, Liso-cel, Follicular Lymphoma
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.
Interventions
DRUGCyclophosphamide
Specified dose on specified days
DRUGDoxorubicin
Specified dose on specified days
DRUGVincristine
Specified dose on specified days
DRUGRituximab
Specified dose on specified days
DRUGPrednisone
Specified dose on specified days
DRUGBendamustine
Specified dose on specified days
DRUGLenalidomide
Specified dose on specified days
DRUGFludarabine
Specified dose on specified days
DRUGLiso-cel
Specified dose on specified days
Sponsors
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Celgene Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 | — |
| 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) |
Contacts
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed