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

Trial ID or NCT#

NCT05371093

Status

recruiting iconRECRUITING

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

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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
    1. Key
Exclusion Criteria:
  1. * 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.
    1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Investigator(s)

Matthew Frank
Blood and marrow transplant specialist, Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

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Contact

Christina Tran
ctran13@stanford.edu

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View on ClinicalTrials.gov