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 - KT-US-473-0133

Kite Pharma Inc.0 sites163 target enrollmentStarted: June 10, 2024Last updated: August 21, 2024

Conditions

Trial Snapshot

No summary available.

•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

•Presence of large B cell lymphoma or transformed FL, 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., 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

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