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

• Status: Not yet recruiting
• Trial end date: 2029-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to determine if axicabtagene ciloleucel is superior to standard of care therapy (SOCT), as measured by progression-free survival (PFS) in participants with relapsed/refractory follicular lymphoma.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kite, A Gilead Company
• Treatments: Bendamustine Hydrochloride; Cyclophosphamide; Doxorubicin; Fludarabine; Lenalidomide; Prednisone; Rituximab; Vincristine

Criteria

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

Exclusion Criteria:

• Transformed FL

• 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 central nervous system (CNS) disorder.

• History of autoimmune disease

• Known history or CNS lymphoma involvement

• Cardiac lymphoma involvement

• History of clinically significant cardiac disease within 6 months of randomization

• Neuropathy greater than Grade 1

• Females who are pregnant or breastfeeding

• Individuals of both genders who are not willing to practice birth control

Note: Other protocol defined Inclusion/Exclusion criteria may apply.