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HMT Inhibitor

Phase 2 Group 3: Tazemetostat in R/R DLBCL for B-Cell Lymphoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Epizyme, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months
Awards & highlights

Summary

This is an open-label, multicenter, Phase 1/2 study of tazemetostat as a single agent in subjects with advanced solid tumors or with B-cell lymphomas and tazemetostat in combination with prednisolone in subjects with diffuse large B-cell lymphoma (DLBCL).

Eligible Conditions
  • B-Cell Lymphoma
  • Solid Tumors
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Large B-Cell Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and radiologic tumor assessments performed at baseline (within 28 days before start of study treatment) and every 8 weeks during cycles 2 to 6, and then every 12 weeks thereafter until confirmed pd/death, a maximum of approximately 82 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR; Complete Response + Partial Response [CR + PR]) (Phase 2)
Recommended Phase 2 Dose (RP2D) of Tazemetostat as a Single-Agent and in Combination With Prednisolone (Phase 1 Only)
Secondary outcome measures
Duration of Response for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)
Progression Free Survival for Tazemetostat as a Single Agent or in Combination With Prednisolone (Phase 2 Only)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 Group 3: Tazemetostat in R/R DLBCLExperimental Treatment2 Interventions
Patients with R/R DLBCL treated with tazemetostat as a single agent or tazemetostat in combination with prednisolone in Phase 2 of the study.
Group II: Phase 2 Group 2: Tazemetostat in R/R FL with Wild-Type EZH2Experimental Treatment1 Intervention
Patients with R/R FL with wild-type EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.
Group III: Phase 2 Group 1: Tazemetostat in R/R FL with Mutant EZH2Experimental Treatment1 Intervention
Patients with R/R FL with mutant EZH2 treated with tazemetostat as a single agent in Phase 2 of the study.
Group IV: Phase 1Experimental Treatment1 Intervention
Patients in the Phase 1 portion of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tazemetostat
2016
Completed Phase 2
~1050
Prednisolone
2005
Completed Phase 4
~2720

Find a Location

Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor
33 Previous Clinical Trials
2,523 Total Patients Enrolled
Ipsen Medical DirectorStudy DirectorIpsen
259 Previous Clinical Trials
55,401 Total Patients Enrolled
~33 spots leftby Sep 2025
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