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NCT04224493 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.
A Phase 3 study of Follicular Lymphoma and Refractory Follicular Lymphoma, sponsored by Epizyme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 612
- Enrollment target
- 20
- Study locations
NCT04224493: Recruiting Phase 3 study of Follicular Lymphoma and Refractory Follicular Lymphoma, sponsored by Epizyme.
NCT04224493 is a Phase 3 study of Follicular Lymphoma and Refractory Follicular Lymphoma that is actively recruiting participants, run by Epizyme. The registered enrollment target is 612 participants, above the 128-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (378% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04224493, a Phase 3 study of Follicular Lymphoma and Refractory Follicular Lymphoma, is actively recruiting participants, sponsored by Epizyme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 612 participants
- Enrollment target
- 20
- Study locations
Study Summary
The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no longer works. Stage 1 of this trial will study the safety and the level that adverse effects of each of the study drug combinations can be tolerated (known as tolerability). It is also designed to establish a recommended study drug dosage for stage 2 and 3. Stage 1 of the study is completed. Stages 2 and 3 will evaluate and compare how long participants live without their disease getting worse when receiving the study drug in combination with other drug treatment versus the placebo (dummy drug) in combination with other drug treatment.
Primary Outcome
The safety and tolerability of tazemetostat in combination with R2 in subjects with R/R FL were evaluated. RP3D of tazemetostat for further evaluation in phase 3 was selected as assessed by the occurrence of treatment-emergent dose-limiting toxicities (DLTs) and adverse events (AEs).
Conditions Studied
Interventions
- DRUG Placebo oral tablet
- DRUG Tazemetostat
- COMBINATION_PRODUCT Lenalidomide
- COMBINATION_PRODUCT Rituximab
Study Locations (20)
Florida
- Cancer Specialists of North Florida - Fleming Island
- Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center - Fort Myers
- Mayo Clinic - Cancer Clinical Research Office - Jacksonville
- Mayo Clinic - Jacksonville
- Miami Cancer Institute - Miami
- Florida Cancer Affiliates/Ocala Oncology - Clinic - Ocala
- BRCR Medical Center, INC - Plantation
- Florida Cancer Specialists - St. Petersburg
- Florida Cancer Specialists - Panhandle - Tallahassee
- H Lee Moffitt Cancer Center and Research Institute I - Tampa
- Florida Cancer Specialists & Research Institute (FCS) - Atlantis - West Palm Beach
California
- TOI - Clinical Research - Cerritos
- UCSF Fresno - Clovis
- UC San Diego Health Sciences - La Jolla
- UCLA Clinical Research Unit Hematology/Oncology - Santa Monica
Colorado
- Rocky Mountain Cancer Centers (RMCC) - Boulder - Boulder
- St. Mary's Hospital and Regional Medical Center - St. Mary's - Grand Junction
- SCL Health Lutheran Medical Center - Greeley
Alabama
- Southern Cancer Center - Mobile
Arizona
- Arizona Oncology Associates - Tuscon-Rusadill Road - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2020-06-11 |
| Est. Completion | 2029-03-01 |
| Phase | Phase 3 |
What NCT04224493 shows while recruiting
NCT04224493 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 128-participant average among 89 other Follicular Lymphoma trials with a reported enrollment target (378% higher).
The record links to 3 conditions, with Follicular Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Placebo oral tablet is the first listed.
NCT04224493 names 20 study sites across 5 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT04224493 about?
NCT04224493 is a clinical study titled "A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenalidomide Plus Rituximab Versus Placebo in Combination With Lenalidomide Plus Rituximab in Adult Patients at Least 18 Years of Age With Relapsed/Refractory Follicular Lymphoma.". The participants of this study would have relapsed/refractory follicular lymphoma. Follicular lymphoma is a type of blood cancer. It is referred to as 'relapsed' when the disease has come back after a period of improvement after that follows a treatment regimen and 'refractory' when treatment no lo...
What is the current status of trial NCT04224493?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 612 participants. The study started on 2020-06-11. Estimated completion is 2029-03-01.
What conditions does trial NCT04224493 study?
This clinical trial studies the following conditions: Follicular Lymphoma, Refractory Follicular Lymphoma, Relapsed/Refractory Follicular Lymphoma.
What interventions are being tested in trial NCT04224493?
The interventions under investigation include: Placebo oral tablet (DRUG), Tazemetostat (DRUG), Lenalidomide (COMBINATION_PRODUCT), Rituximab (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT04224493?
This trial is sponsored by Epizyme, which has 16 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04224493 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Follicular Lymphoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04224493's enrollment target sits among peer trials
612 5th of 89 higher than 85 of 89 other Follicular Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Follicular Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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