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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.
NCT04224493 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04224493
The ClinicalTrials.gov registry entry for NCT04224493 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 612 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Epizyme, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04224493 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04224493?
This trial is sponsored by Epizyme, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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