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 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
View All Criteria
Show Less

Investigator(s)

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

Contact us to find out if this trial is right for you.

Contact

Christina Tran
ctran13@stanford.edu

SEND MESSAGE

View on ClinicalTrials.gov