Tazemetostat/placebo with lenalidomide + rituximab for R/R FL
Research type
Research Study
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
IRAS ID
288875
Contact name
Pamela McKay
Contact email
Sponsor organisation
Epizyme, Inc.
Eudract number
2019-003333-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Epizyme, Inc. is sponsoring a study to measure the efficacy of the 3-drug combination of tazmetostat + lenalidomide + rituxumab in patients with Refractory or Relapsed follicular lymphoma (R/R FL) who have completed at least 1 prior medical therapy.
Follicular lymphoma (FL) is a cancer of the white blood cells (lymphocytes).Tazemetostat is an approved drug that targets and kills certain cancer cells by blocking the activity of a protein called histone lysine methyltransferase enhancer of zeste homolog 2 (EZH2) from working. The EZH2 protein helps regulate the development of B cells (a type of white blood cells, responsible for the body’s immune response). When EZH2 is overactive, B-cells do not develop correctly, and they continue to grow unchecked. This is one of the causes of follicular lymphoma.
The combination of lenalidomide and rituximab has been approved to treat R/R FL. However, the combined study treatment of tazemetostat/placebo with lenalidomide and rituximab is not yet approved.
Previous studies have shown that treatment with rituximab has substantially improved long-term disease control. This study will help us understand more about whether tazemetostat in combination with lenalidomide and rituximab will be a useful treatment for subjects with R/R FL.
All participants will be randomly assigned into one of two study treatment groups:
• Tazemetostat + lenalidomide + rituximab, or
• Placebo + lenalidomide + rituximab.Participants, investigators, study staff, sponsor and sponsor representatives will remain blinded to the treatment assignment. This means that neither the participants nor the researchers will know what treatment is being assigned.
Approximately 500 participants will take part in this study across 158 sites around the world. Overall, the study will last for approximately four years, however the duration of a participant’s time in the trial will be approximately three years.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0064
Date of REC Opinion
26 May 2021
REC opinion
Further Information Favourable Opinion