Study to Compare Axicabtagene Ciloleucel With Standard of Care Therapy as First-line Treatment in Participants With High-risk Large B-cell Lymphoma

Conditions

• High-risk Large B-cell Lymphoma (LBCL)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Axicabtagene Ciloleucel — BIOLOGICAL
  A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
• Cyclophosphamide — DRUG
  Administered intravenously
• Fludarabine — DRUG
  Administered intravenously
• Etoposide — DRUG
  Administered intravenously
• Rituximab — DRUG
  Administered intravenously
• Doxorubicin — DRUG
  Administered intravenously
• Vincristine — DRUG
  Administered intravenously
• Prednisone — DRUG
  Administered orally

Study Details

The goal of this clinical study is to compare the study drug, axicabtagene ciloleucel, versus standard of care (SOC) in first-line therapy in participants with high-risk large B-cell lymphoma.

Key Dates

Start date

Feb 10, 2023

Status verified

Apr 2026

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Axicabtagene Ciloleucel
  Participants will receive cyclophosphamide 500 mg/m\^2/day intravenously (IV) and fludarabine 30 mg/m\^2/day IV lymphodepletion chemotherapy for 3 days followed by axicabtagene ciloleucel administered as a single IV infusion at a target dose of 2 x 10\^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells/kg on Day 0.
• Active Comparator: Standard of Care Therapy
  Participants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for a total of 6 cycles (21-day cycle) * Rituximab 375 mg/m\^2 on Day 1 * Cyclophosphamide 750 mg/m\^2 on Day 1 * Doxorubicin 50 mg/m\^2 on Day 1 * Vincristine 1.4 mg/m\^2 (maximum 2 mg) on Day 1 * Prednisone 40 mg/m\^2 on Day 1 through Day 5 * Dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab (DA-EPOCH-R) for a total of 6 cycles (21-day cycle) * Rituximab 375 mg/m\^2 on Day 1 * Etoposide 50 mg/m\^2 on Days 1 to 4 * Doxorubicin 10 mg/m\^2 on Days 1 to 4 * Vincristine 0.4 mg/m\^2 on Days 1 to 4 * Cyclophosphamide 750 mg/m\^2 on Day 5 * Prednisone 60 mg/m\^2 twice daily on Days 1 to 5

Primary Outcome Measure

Event-free Survival (EFS) by Blinded Central Assessment [ Time Frame: Up to 5 years ]

Locations (32)

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