Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma
Trial ID or NCT#
Status
Purpose
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Official Title
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
Eligibility 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
- * 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.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Christina Tran
ctran13@stanford.edu
View on ClinicalTrials.gov