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A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma


Description

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphomaFive years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Trial Eligibility

Key Inclusion Criteria: * Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a) * Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy * Clinical indication for treatment. * At least 1 measurable lesion per the Lugano Classification {Cheson 2014} * Adequate renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: * Presence of large B cell lymphoma or transformed FL * Small lymphocytic lymphoma * Lymphoplasmacytic lymphoma * Full-thickness involvement of the gastric wall by lymphoma * FL Grade 3b * Prior CD19-targeted therapy * Prior CAR therapy or other genetically modified T-cell therapy * Uncontrolled fungal, bacterial, viral, or other infection * Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus * History or presence of a clincially significant central nervous system (CNS) disorder. * History of autoimmune disease * Known history or CNS lymphoma involvement * Cardiac lymphoma involvement * History of clinically significant cardiac disease 6 months before randomization * Neuropathy greater than grade 2 * Females who are pregnant or breastfeeding * Individuals of both genders who are not willing to practice birth control * Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Info

Organization

Gilead Sciences


Primary Outcome

Progression-free Survival (PFS) as Assessed by Blinded Central Assessment per Lugano Classification


Outcome Timeframe Up to 5 years

NCTID NCT05371093

Phases PHASE3

Primary Purpose TREATMENT

Start Date 2022-09-12

Completion Date 2030-10

Enrollment Target 230

Interventions

BIOLOGICAL Axicabtagene Ciloleucel

DRUG Cyclophosphamide

DRUG Fludarabine

DRUG Lenalidomide

DRUG Rituximab

DRUG Doxorubicin

DRUG Vincristine

DRUG Prednisone

DRUG Bendamustine

Locations Recruiting

University of Arkansas for Medical Sciences

United States, Arkansas, Little Rock


City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

United States, California, Duarte


UC Irvine Health

United States, California, Orange


Stanford Health Care

United States, California, Stanford


Colorado Blood Cancer Institute

United States, Colorado, Denver


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