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

Sponsor
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Study ID
NCT06313996
Phase
PHASE3
Status
Withdrawn

Conditions

  • Relapsed or Refractory Follicular Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Specified dose on specified days
  • Doxorubicin — DRUG
    Specified dose on specified days
  • Vincristine — DRUG
    Specified dose on specified days
  • Rituximab — DRUG
    Specified dose on specified days
  • Prednisone — DRUG
    Specified dose on specified days
  • Bendamustine — DRUG
    Specified dose on specified days
  • Lenalidomide — DRUG
    Specified dose on specified days
  • Fludarabine — DRUG
    Specified dose on specified days
  • Liso-cel — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Mar 29, 2024
Status verified
Mar 2026
Primary completion
Oct 16, 2031
Completion
Oct 16, 2031

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Active Comparators: R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) B-R (bendamustine and rituximab) R2 (rituximab and lenalidomide)
  • Experimental: Arm B
    Lisocabtagene Maraleucel

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Up to 5 years from the last participant randomized ]

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