Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
Kite, A Gilead Company
Study ID
NCT05371093
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Relapsed/Refractory Follicular Lymphoma

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
  • Lenalidomide — DRUG
    Administered orally
  • Rituximab — DRUG
    Administered intravenously
  • Doxorubicin — DRUG
    Administered intravenously
  • Vincristine — DRUG
    Administered intravenously
  • Prednisone — DRUG
    Administered orally
  • Bendamustine — DRUG
    Administered intravenously

Study Details

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Key Dates

Start date
Sep 22, 2022
Status verified
Oct 2025
Primary completion
Oct 31, 2030
Completion
Oct 31, 2030

Study Design

Enrollment
231 participants (actual)
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 lymphodepleting 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. For participants weighing ≥ 100 kg, a maximum flat dose of axicabtagene ciloleucel at 2 x 10\^8 anti-CD19 CAR T cells will be administered.
  • Active Comparator: Standard of Care Therapy
    Participants will receive the investigator's choice of one of the following therapies/dosing schedules: * Rituximab plus lenalidomide (R\^2) for 12 cycles (28-day cycle) * Cycle 1: lenalidomide 20 mg/day on Day 1 through Day 21; rituximab 375 mg/m\^2 on Day 1, Day 8, Day 15, and Day 22 * Cycle 2 through Cycle 5: lenalidomide 20 mg/day on Day 1 through Day 21; Rituximab 375 mg/m2 on Day 1 * Cycle 6 through Cycle 12: lenalidomide 20 mg/day on Day 1 through Day 21 * Rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for 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 * Rituximab plus bendamustine (BR) for 6 cycles (28-day cycle) * rituximab 375 mg/m\^2 on Day 1 * bendamustine 90 mg/m\^2 on Day 1 and Day 2

Primary Outcome Measure

Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification [ Time Frame: Up to 5 years ]

Locations (12)

FacilityCityStateZIPSite coordinators
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91010-
Stanford Health CareStanfordCalifornia94305-
Moffitt Cancer CenterTampaFlorida33612-
The University of Kansas HospitalWestwoodKansas66205-
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Novant Health Cancer Institute Hematology - CharlotteCharlotteNorth Carolina28204-
Penn State Milton S. Hershey Medical CenterHersheyPennsylvania17033-
Henry-Joyce Cancer ClinicNashvilleTennessee37232-
TriStar Centennial Medical Center - Cell ProcessingNashvilleTennessee37203-
The University of Texas MD Anderson Cancer CenterHoustonTexas77030-
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Duarte, CA

By research site
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CAStanford Health Care· Stanford, CAMoffitt Cancer Center· Tampa, FLThe University of Kansas Hospital· Westwood, KSUniversity of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MDDana-Farber Cancer Institute· Boston, MA

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