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

Sponsor: Kite, A Gilead Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05371093

Patient View

This study evaluates axicabtagene ciloleucel in relapsed/refractory follicular lymphoma. Participants transition to a long-term follow-up after five years. Eligibility includes histologically-confirmed FL, relapsed/refractory disease, and adequate organ function. Interventions involve CAR-T cell therapy and various chemotherapy agents, including cyclophosphamide and fludarabine.

Patient Parameters

Program Overview

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Description

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Eligibility Criteria

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

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 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.

Get This Program In Your Inbox

You can sign up and apply your patients for this program.