Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

EZH-302 : 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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Blood<br/>CancersCancer LocationBlood
Cancers

Systemic therapy | Blood / Myeloma / LymphomaFollicular Lymphoma

Trial Overview Read MoreRead more

This Phase III trial is evaluating how safe and effective a targeted therapy (tazemetostat) is in combination with other cancer drugs (lenalidomide and rituximab) in people with follicular lymphoma who have had at least one prior treatment of chemotherapy, immunotherapy or chemoimmunotherapy.
 

This trial is treating patients with relapsed or refractory follicular lymphoma.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You are able to swallow medication by mouth.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific 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

Commercial Sponsor

Epizyme, Inc.

Summary

This is a randomised trial with Active Comparator and Placebo Comparator arms. Participants in the Active Comparator Arm will receive Tazemetostat in combination with R2 (Lenalidomide and Rituzimab). Tazemetostat RP3D will be administered orally, PO twice daily in continuous 28-day cycles for 12 cycles. Rituximab will be administered intravenously at 375mg/m2 on days 1, 8, 15 and 22 of cycle 1; then on day 1 of cycles 2 to 5. Lenalidomide will be administered orally, at 20mg (if creatinine clearance ≥60 mL/minute) or 10 mg (if creatinine clearance <60 ml/minute)="" po="" qd="" on="" days="" 1="" to="" 21="" for="" 12="" cycles.="" participants="" in="" the="" placebo="" comparator="" arm="" will="" receive="" a="" placebo="" in="" combination="" with="" r2.="" placebo="" tablets="" will="" be="" administered="" orally="" po="" twice="" daily="" in="" continuous="" 28-day="" cycles="" for="" 12="" cycles.="" rituximab="" and="" lenalidomide="" will="" be="" administered="" on="" the="" same="" schedules="" as="" those="" in="" the="" active="" comparator="" arm,="" described="" above.="" the="" study="" has="" three="" phases:="" stage="" 1="" is="" a="" safety="" run-in="" phase,="" stage="" 2="" is="" an="" efficacy="" and="" safety="" phase="" for="" assessment="" of="" the="" ezh2="" mutant="" type="" population="" and="" overall="" follicular="" lymphoma="" population="" regardless="" of="" ezh2="" mutation="" status,="" and="" optional="" stage="" 3="" with="" efficacy="" and="" safety="" phase="" for="" subjects="" with="" ezh2="">

Recruiting Hospitals Read MoreRead more

Barwon Health, University Hospital Geelong
Geelong
Haematology Team
HaematologyTrials@barwonhealth.org.au

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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