Trials / Recruiting
RecruitingNCT04224493
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.
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
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 612 (estimated)
- Sponsor
- Epizyme, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Stage 1 of the study, which is now completed, looked at the safety and tolerability of the drug combinations and helped determine the recommended dose for the next stages. In Stage 2, participants will be grouped based on whether they have a specific genetic mutation called EZH2. All participants will receive treatment in 28-day cycles. After 12 cycles, they will continue with maintenance treatment using either the study drug or a placebo, depending on their original group. The study will include participants with and without the EZH2 mutation. Enrollment may be completed separately for each group. In China, some participants will also have extra blood tests to better understand how the drug behaves in the body. Stage 3 will focus on long-term follow-up to monitor how well the treatment works, how safe it is, and how long participants live. All participants will be followed for up to 5 years after the last person joins the study
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tazemetostat | Stage 1 (Phase 1b): Tazemetostat was escalated from a starting dose of 400 mg orally twice daily to 600 mg orally twice daily to 800 mg PO twice daily in 28-day cycles as tolerated in a standard 3 + 3 design. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy. |
| DRUG | Tazemetostat | Stage 2: Tazemetostat 800 mg administered orally twice daily in continuous 28-day cycles for 12 cycles. Tazemetostat will be administered as monotherapy at an 800 mg twice daily dose for up to 2 years after the initial 12 months of combination therapy. |
| DRUG | Placebo oral tablet | Stage 2: Placebo administered orally twice daily in continuous 28-day cycles. Placebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. |
| COMBINATION_PRODUCT | Lenalidomide | Lenalidomide 20 mg capsules or 10 mg capsules (if creatinine clearance ≥60 mL/minute or \<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles. |
| COMBINATION_PRODUCT | Rituximab | Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5. |
Timeline
- Start date
- 2020-06-11
- Primary completion
- 2026-03-01
- Completion
- 2029-03-01
- First posted
- 2020-01-13
- Last updated
- 2026-03-02
Locations
229 sites across 17 countries: United States, Australia, Belgium, Brazil, Canada, China, France, Germany, Hungary, Italy, Poland, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04224493. Inclusion in this directory is not an endorsement.