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.
Public ClinicalTrials.gov record NCT04224493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Symphony-1: 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 studied 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 were designed to 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. However, following an urgent safety measure, treatment with tazemetostat and placebo was discontinued, enrollment was stopped, and the study was unblinded. As a result, post-urgent safety measure analyses are descriptive in nature.
Study identification
- NCT ID
- NCT04224493
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 599 participants
Conditions and interventions
Conditions
Interventions
- Tazemetostat Drug
- Placebo oral tablet Drug
- Lenalidomide Combination Product
- Rituximab Combination Product
Drug · Combination Product
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 11, 2020 (Actual)
- Primary completion
- Feb 13, 2027 (Estimated)
- Completion
- Mar 1, 2029 (Estimated)
- Last update posted
- Oct 5, 2026
2020 – 2029
United States locations
- U.S. sites
- 57
- U.S. states
- 21
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center | Mobile | Alabama | 36608 | — |
| Arizona Oncology Associates - Tuscon-Rusadill Road | Tucson | Arizona | 85704 | — |
| TOI - Clinical Research | Cerritos | California | 90703 | — |
| UCSF Fresno | Clovis | California | 93611 | — |
| UC San Diego Health Sciences | La Jolla | California | 92093 | — |
| UCLA Clinical Research Unit Hematology/Oncology | Santa Monica | California | 90404 | — |
| Rocky Mountain Cancer Centers (RMCC) - Boulder | Boulder | Colorado | 80303 | — |
| St. Mary's Hospital and Regional Medical Center - St. Mary's | Grand Junction | Colorado | 81501 | — |
| Cancer Specialists of North Florida | Fleming Island | Florida | 32003 | — |
| Florida Cancer Specialists & Research Institute (FCS) - Fort Myers Cancer Center | Fort Myers | Florida | 33908 | — |
| Mayo Clinic | Jacksonville | Florida | 32224 | — |
| Florida Cancer Affiliates/Ocala Oncology - Clinic | Ocala | Florida | 34474 | — |
| BRCR Medical Center, INC | Plantation | Florida | 33322 | — |
| Florida Cancer Specialists | St. Petersburg | Florida | 33705 | — |
| Florida Cancer Specialists - Panhandle | Tallahassee | Florida | 32308 | — |
| H Lee Moffitt Cancer Center and Research Institute I | Tampa | Florida | 33612 | — |
| Florida Cancer Specialists & Research Institute (FCS) - Atlantis | West Palm Beach | Florida | 33401 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Illinois Cancer Specialists | Niles | Illinois | 60714 | — |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | 48109 | — |
| St. Joseph Mercy Hospital | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55901 | — |
| University Of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Astera Cancer Care | East Brunswick | New Jersey | 08816 | — |
| Astera Cancer Center | East Brunswick | New Jersey | 08816 | — |
| Regional Cancer Care Associates-Freehold | Freehold | New Jersey | 07728 | — |
| Regional Cancer Care Associates LLC - Little Silver | Little Silver | New Jersey | 07739 | — |
| New Mexico Cancer Care Alliance | Albuquerque | New Mexico | 87131-0001 | — |
| Weill Cornell Medicine-New York Presbyterian Hospital | New York | New York | 10021 | — |
| Columbia U - Herbert Irving Comprehensive Cancer Center | New York | New York | 10032 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Hematology Oncology Associates of Rockland, P.C. | Nyack | New York | 10960 | — |
| Messino Cancer Center | Asheville | North Carolina | 28806 | — |
| Levine Cancer Institute - Concord | Concord | North Carolina | 28205 | — |
| FirstHealth of the Carolinas | Pinehurst | North Carolina | 28374 | — |
| Regional Medical Oncology Center | Wilson | North Carolina | 27895 | — |
| Gabrail Cancer Center Research | Canton | Ohio | 44718 | — |
| Oncology Hematology Care (OHC), Inc. - Kenwood Office | Cincinnati | Ohio | 45236 | — |
| Willamette Valley Cancer Institute and Research Center - Oncology | Eugene | Oregon | 97401 | — |
| Western Pennsylvania Hospital Hematology & Cellular Therapy | Pittsburgh | Pennsylvania | 15524 | — |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Amarillo | Amarillo | Texas | 79124 | — |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology - Medical City Dallas Pediatric Hematology | Dallas | Texas | 75230 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Millennium Physicians - Oncology | Houston | Texas | 77090 | — |
| Texas Oncology | Plano | Texas | 75075 | — |
| Mays Cancer Center | San Antonio | Texas | 78229 | — |
| UT Health East Texas HOPE Cancer Center - Tyler | Tyler | Texas | 75701 | — |
| USO Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Texas Oncology- Weslaco | Weslaco | Texas | 78596 | — |
| Utah Cancer Specialists/ IHO Corp | Salt Lake City | Utah | 84106 | — |
| Huntsman Cancer Institute; The University of Utah | Salt Lake City | Utah | 84112 | — |
| Virginia Cancer Specialists | Gainesville | Virginia | 22155 | — |
| Oncology and Hematology Associates of Southwest Virginia Inc. | Roanoke | Virginia | 24014 | — |
| Wheeling Hospital | Wheeling | West Virginia | 26003 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 147 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04224493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 5, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04224493 live on ClinicalTrials.gov.