Phase III Study Comparing Tisagenlecleucel to Standard Treatment in Adults with Difficult-to-Treat Follicular Lymphoma

Sponsor: Novartis Pharmaceuticals

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05888493

Provider View

This clinical trial is testing whether a new treatment called tisagenlecleucel is more effective than the usual treatments for adults with follicular lymphoma that has returned or not responded to previous therapies.

Patient Parameters

Program Overview

The study aims to find out if tisagenlecleucel, a new treatment, can help patients with follicular lymphoma that has come back or not responded to at least two previous treatments. The main goal is to see if this new treatment can help patients live longer without their disease getting worse, compared to the standard treatments currently used.

Description

In this study, researchers are comparing a new treatment called tisagenlecleucel with the standard treatments for follicular lymphoma that has returned or not responded to previous therapies. The main focus is on how long patients can live without their disease getting worse.

Participants will be divided into two groups. One group will receive a single infusion of tisagenlecleucel, which involves using modified T-cells to target cancer cells. The other group will receive standard treatments, which may include R2 or R-CHOP, as decided by the doctor before the study starts.

The study will measure how well each treatment works by looking at how long patients live without their disease progressing, as assessed by an independent review committee using specific criteria.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older.
  • Diagnosed with follicular lymphoma grades 1, 2, or 3A after the most recent relapse.
  • The disease has returned or not responded after at least two previous treatments, including specific types of drugs.
  • The cancer is active and measurable on scans.
  • Generally good health with an ECOG performance status of 0, 1, or 2.
  • Good blood, kidney, liver, and lung function.
  • Eligible for a procedure to collect white blood cells, unless previously done.
  • Eligible for the chosen standard treatment regimen.

Exclusion Criteria

  • Follicular lymphoma grade 3B or signs of the disease changing to a more aggressive form.
  • Previous treatments with certain types of cell or gene therapies.
  • Cancer has spread to the brain or spinal cord.
  • Active infections, including HIV or hepatitis B or C.
  • Active autoimmune or inflammatory neurological disorders.
  • Participation in another clinical trial within the last 30 days.
  • Serious heart conditions like recent heart attacks or severe heart failure.

Other specific criteria may apply.

Get This Program In Your Inbox

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