Study Comparing Axicabtagene Ciloleucel to Standard Treatment for Relapsed or Hard-to-Treat Follicular Lymphoma

Sponsor: Kite, A Gilead Company

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05371093

Provider View

This clinical trial is testing how well a new treatment, axicabtagene ciloleucel, works for patients with follicular lymphoma that has returned or is difficult to treat after previous therapies.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness of axicabtagene ciloleucel, a new treatment, in patients with follicular lymphoma that has come back or is not responding to standard treatments. Participants who receive this treatment will be followed for up to 15 years to monitor their health and the long-term effects of the therapy.

Description

Five years after the last participant joins the study, those who received axicabtagene ciloleucel will move to a separate long-term follow-up study to continue monitoring their health for a total of 15 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with follicular lymphoma (FL) of Grade 1, 2, or 3a.
  • The lymphoma has returned or not responded after initial treatment and is considered high-risk if it relapsed or progressed within 24 months of the first treatment, or has not responded after at least two previous treatments.
  • There is a need for treatment based on medical evaluation.
  • At least one tumor that can be measured using standard medical criteria.
  • Sufficient kidney, liver, lung, and heart function.

Exclusion Criteria

  • Presence of large B cell lymphoma or transformed follicular lymphoma.
  • Diagnosed with small lymphocytic lymphoma or lymphoplasmacytic lymphoma.
  • Lymphoma affecting the full thickness of the stomach wall.
  • Follicular lymphoma of Grade 3b.
  • Previous treatment targeting CD19 or with CAR-T or other genetically modified T-cell therapies.
  • Uncontrolled infections, including fungal, bacterial, or viral.
  • Active infection with HIV, hepatitis B, or hepatitis C.
  • History or current significant central nervous system disorders.
  • History of autoimmune diseases.
  • Known involvement of the central nervous system or heart by lymphoma.
  • Significant heart disease within six months before joining the study.
  • Severe nerve damage (neuropathy) greater than grade 2.
  • Women who are pregnant or breastfeeding.
  • Individuals not willing to use birth control.
  • Presence of any indwelling medical lines or drains, except for specific types of central venous access catheters.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.