Tazemetostat + R2 Arm for Lymphoma, Follicular

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Lymphoma, Follicular+2 More
Lenalidomide - CombinationProduct
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new combination drug to treat people with a certain type of lymphoma who have not responded to other treatments. The trial will use biomarkers to select patients most likely to benefit from the new drug.

Eligible Conditions
  • Lymphoma, Follicular

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

5 Primary · 16 Secondary · Reporting Duration: Time from the date of randomization to the time of confirmed disease progression per the 2014 Lugano Classification (Cheson, 2014) or death, whichever occurs first, assessed up to 72 months.

Day 28
Peak Plasma Concentration Cmax
Day 28
RP3D of tazemetostat in combination with R2
Day 28
Stage 1: RP3D of tazemetostat in combination with R2
Day 30
Number of participants with treatment-related adverse events
Year 3
EuroQOL
Day 28
Pharmacokinetics of tazemetostat Maximum Plasma Concentration Cmax.
Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 will be selected at the end of Phase 1b
Recommended Phase 3 Dose o(RP3D) of tazemetostat in combination with R2
Hour 72
Stage 2: Duration of complete response
Month 72
Stage 2: Duration of response
Month 72
Stage 2: Progression-free Survival (PFS)
up to 100 weeks
Overall Survival
Overall Survival (OS)
up to 72 months
Disease control rate
Duration of complete response
Duration of complete response (DOCR)
Duration of response
Duration of response (DOR)
Objective Response Rate
Objective Response Rate (ORR)
PFS
Progression-free Survival (PFS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Tazemetostat + R2 Arm
1 of 2
Placebo + R2 Arm
1 of 2
Active Control
Non-Treatment Group

540 Total Participants · 2 Treatment Groups

Primary Treatment: Tazemetostat + R2 Arm · Has Placebo Group · Phase 3

Placebo + R2 ArmPlaceboComparator Group · 3 Interventions: Placebo oral tablet, Lenalidomide, Rituximab · Intervention Types: Drug, CombinationProduct, CombinationProduct
Tazemetostat + R2 ArmActiveComparator Group · 3 Interventions: Lenalidomide, Tazemetostat, Rituximab · Intervention Types: CombinationProduct, Drug, CombinationProduct

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: time from the date of randomization to the time of confirmed disease progression per the 2014 lugano classification (cheson, 2014) or death, whichever occurs first, assessed up to 72 months.

Who is running the clinical trial?

Epizyme, Inc.Lead Sponsor
30 Previous Clinical Trials
2,391 Total Patients Enrolled
5 Trials studying Lymphoma, Follicular
670 Patients Enrolled for Lymphoma, Follicular

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have voluntarily agreed to participate in the study and demonstrate willingness and ability to comply with all aspects of the protocol.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
65+100.0%
What site did they apply to?
Assistant professor of medicine - Oncology100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%