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RecruitingLast updated:15 August 2023

EZH-302: 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 chemoimmunotherapyA 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

Clinical summary Eligibilty Participating hospital Support

Clinical summary

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 â‰¥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="">

Age

People 18+

Phase

III

Trial Acronym

EZH-302

More information

Trial Identifiers

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

NCT04224493

Commercial Sponsor

Epizyme, Inc.

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

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Eligibility

Inclusion

You have certain types of non-cancer medical conditions.
You have been diagnosed with a prior or secondary type of cancer.
You have had certain treatments, surgical procedures or drugs.

Exclusion

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.

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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