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

Interventions

Locations Recruiting

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