Study on Tazemetostat with Lenalidomide and Rituximab vs. Placebo for Adults with Relapsed/Refractory Follicular Lymphoma

Sponsor: Epizyme, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04224493

Provider View

This clinical trial is testing a new combination of drugs, Tazemetostat with Lenalidomide and Rituximab, against a placebo to see if it can help treat adults with follicular lymphoma that has returned or stopped responding to treatment.

Patient Parameters

Program Overview

This study involves adults with follicular lymphoma, a type of blood cancer, that has either come back after treatment (relapsed) or stopped responding to treatment (refractory). The trial is in three stages. Stage 1, which is completed, focused on safety and finding the right dose. Stages 2 and 3 will compare how long patients live without their disease worsening when taking the study drug combination versus a placebo.

Description

The study is divided into three stages:

  • Stage 1: This phase was about checking the safety of the drug combination and finding the right dose. It is now completed.

  • Stage 2: This phase will test how effective and safe the treatment is for patients with and without a specific genetic mutation (EZH2). Patients will be randomly assigned to receive either the study drug combination or a placebo, along with other treatments. There will be interim analyses to check the progress.

  • Stage 3: This phase involves long-term follow-up to assess how patients respond to the treatment and their overall survival for up to five years after the last patient joins the study.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older and agree to participate by signing a consent form.
  • Have a life expectancy of at least 3 months.
  • Must meet specific requirements for hepatitis and HIV infections.
  • Have a confirmed diagnosis of follicular lymphoma, Grades 1 to 3A.
  • Must have had at least one prior treatment for lymphoma.
  • Must have relapsed or refractory disease after previous treatment.
  • Have measurable disease as per specific medical criteria.
  • Must have a performance status score of 0, 1, or 2, indicating good overall health.
  • Must provide a tumor sample for genetic testing.
  • Must have adequate kidney, bone marrow, and liver function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception.
  • Men must agree to use a condom during sexual contact and not donate sperm during and after the study.
  • Must be willing to comply with a pregnancy prevention program if applicable.

Exclusion Criteria

  • Previous treatment with Tazemetostat or similar drugs.
  • Previous treatment with Lenalidomide or similar drugs.
  • Have a different type of lymphoma or cancer that has transformed.
  • Have severe blood disorders or a history of certain blood cancers.
  • Have uncontrolled brain metastases or a history of treated brain metastases.
  • Taking certain medications that interact with the study drugs.
  • Have had major surgery recently.
  • Have significant heart problems or other serious medical conditions.
  • Have active infections requiring treatment.
  • Have known allergies to the study drugs.
  • Have active hepatitis B or C infections.
  • Have any condition that would interfere with the study or increase risk.
  • Women who are pregnant or breastfeeding.
  • Have had a solid organ transplant.
  • Have other active cancers, with some exceptions.

Get This Program In Your Inbox

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