A Phase IB/III Study of Lenalidomide and Rituximab plus Tazemetostat or Placebo in Patients with Recurrent or Persistent Follicular Lymphoma

Share
Print

Full Title

A Phase 1B/3 Double-Blind, Randomized, Active-Controlled, 3-Stage, Biomarker Adaptive Study of Tazemetostat or Placebo In Combination With Lenalidomide Plus Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma

Purpose

The purpose of this study is to find out whether tazemetostat, combined with lenalidomide and rituximab, is a safe and effective treatment for follicular lymphoma that has come back or continued to grow despite prior therapy. All three medications have been approved by the U.S. Food and Drug Administration to treat this disease.

In this study, researchers want to find the best doses of rituximab, lenalidomide, and tazemetostat to give in combination and see how effective they are against follicular lymphoma. Patients will be randomly assigned to receive lenalidomide and rituximab with tazemetostat or a placebo. Lenalidomide and tazemetostat are taken orally (by mouth) and rituximab is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have follicular lymphoma that came back or continued to grow despite at least one prior regimen of chemotherapy, immunotherapy, or chemoimmunotherapy.
  • Patients may not have previously received lenalidomide or tazemetostat.
  • Patients should recover from the serious side effects of prior therapies before receiving the study treatment.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information and to inquire about eligibility for this study, please contact Dr. Connie Lee Batlevi at 646-497-9154.

Protocol

20-252

Phase

III

Investigator

Co-Investigators