A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma

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.
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Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm ADoxorubicinActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm AVincristineActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm ABendamustineActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm ALenalidomideActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm ARituximabActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm APrednisoneActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Arm BFludarabineLisocabtagene Maraleucel
Arm BLiso-celLisocabtagene Maraleucel
Arm ACyclophosphamideActive Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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 rateUp to 5 years from the last participant randomized
EFS rateUp to 5 years from the last participant randomized
OS rateUp 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 abnormalitiesUp to 5 years from the last participant randomized
Frequency and length of hospitalizationsUp to 5 years from the last participant randomized
Number of participants with intensive care unit (ICU) inpatient daysUp to 5 years from the last participant randomized
Number of participants with non-ICU inpatient daysUp 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:
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Time to meaningful improvement/deterioration in key HRQoL domains.Up to 5 years from the last participant randomized

Key HRQoL Domains:
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