Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
completion around

Description

Summary

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

Details

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.

Keywords

Relapsed/Refractory Follicular Lymphoma, Lymphoma, Follicular Lymphoma, Prednisone, Cyclophosphamide, Bendamustine Hydrochloride, Rituximab, Doxorubicin, Fludarabine, Vincristine, Lenalidomide, Axicabtagene ciloleucel, Bendamustine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • UC Irvine Health accepting new patients
    Orange California 92868 United States
  • City of Hope (City of Hope National Medical Center, City of Hope Medical Center) accepting new patients
    Duarte California 91010 United States
  • Stanford Health Care accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Kite, A Gilead Company
Links
Gilead Clinical Trials Website
ID
NCT05371093
Phase
Phase 3 Lymphoma Research Study
Study Type
Interventional
Participants
Expecting 230 study participants
Last Updated