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


I'm Interested

Trial ID: NCT05371093


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

Stanford Investigator(s)

Matthew Frank

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)


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

   - 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

   - 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.


biological: Axicabtagene Ciloleucel

drug: Cyclophosphamide

drug: Fludarabine

drug: Lenalidomide

drug: Rituximab

drug: Doxorubicin

drug: Vincristine

drug: Prednisone

drug: Bendamustine


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Christina Tran

New Trial Alerts