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Trial Title:
A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
NCT ID:
NCT06313996
Condition:
Relapsed or Refractory Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Prednisone
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Doxorubicin
Fludarabine
Vincristine
Lenalidomide
Conditions: Keywords:
Lisocabtagene Maraleucel
Liso-cel
Follicular Lymphoma
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Specified dose on specified days
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Fludarabine
Description:
Specified dose on specified days
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Liso-cel
Description:
Specified dose on specified days
Arm group label:
Arm B
Other name:
Lisocabtagene Maraleucel
Other name:
BREYANZI
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 29, 2024
Completion date:
October 16, 2031
Lead sponsor:
Agency:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Agency class:
Industry
Collaborator:
Agency:
Celgene Corporation
Agency class:
Industry
Source:
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06313996
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsstudyconnect.com/s/US/English/USenHome
https://www.bms.com/researchers-and-partners/investigator-inquiry-form.html
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
