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.

Study acronym: SYMPHONY-1
StatusActive, Not Recruiting
PhasePhase 3
Started

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Trial flagged as At Risk
Primary endpoints added 3 → 5 primary endpoints
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Record History

The 50 most recent of 78 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoints: details revised at 1 of 5 entries
    • Eligibility criteria expanded, about 61 words
    • Secondary endpoints: details revised at 20 of 30 entries
    • Site details revised at 36 of 204 sites
  2. Primary endpoint(s) modified
    • Secondary endpoints: 38 to 30
    • Study description shortened, about 6 words
    • Site details revised at 13 of 204 sites
    v77
  3. 2 versions Re-verified since Jun 30, 2026, no change to tracked fieldsv75-v76
  4. Enrollment target: 555 to 599v74
  5. Primary completion pushed from Mar 1, 2026 to Feb 13, 2027
    • Trial status changed: Recruiting → Active, Not Recruiting
    • Trial sites reduced: 229 → 204 locations
    • Enrollment target: estimated 612 to confirmed 555
    v73
Show 44 earlier versionsHide 44 earlier versions
  1. Re-verified, no change to tracked fieldsv72
  2. Study sites: 227 to 229v71
  3. Study sites: 222 to 227
    • Eligibility criteria expanded, about 132 words
    • Study description expanded, about 5 words
    v70
  4. 2 versions Re-verified since Oct 29, 2025, no change to tracked fieldsv68-v69
  5. Study sites: 217 to 222v67
  6. Study sites: 209 to 217v66
  7. Study sites: 208 to 209v65
  8. Study sites: 206 to 208v64
  9. Study sites: 203 to 206v63
  10. Study sites: 192 to 203v62
  11. 4 versions Re-verified since Dec 20, 2024, no change to tracked fieldsv58-v61
  12. Study sites: 170 to 192v57
  13. 4 versions Re-verified since Jul 31, 2024, no change to tracked fieldsv53-v56
  14. Study sites: 162 to 170
    • Study title expanded, about 20 words
    • Eligibility criteria shortened, about 2 words
    v52
  15. Re-verified, no change to tracked fieldsv51
  16. Primary completion date: Sep 30, 2029 to Mar 1, 2026
    • Study completion date: Apr 27, 2032 to Mar 1, 2029
    v50
  17. Primary endpoints: 2 to 3
    • Eligibility criteria revised
    • Secondary endpoints: 25 to 38
    v49
  18. Primary completion date: Mar 1, 2026 to Sep 30, 2029v48 Show 5 more changesShow less
    • Start date: Dec 19, 2019 to Jun 11, 2020
    • Enrollment target: 540 to 612
    • Study sites: 161 to 162
    • Study completion date: Mar 1, 2029 to Apr 27, 2032
    • Eligibility criteria expanded, about 16 words
  19. Study sites: 160 to 161v47
  20. 2 versions Re-verified since Dec 29, 2023, no change to tracked fieldsv45-v46
  21. Primary completion date: Mar 2026 to Mar 1, 2026
    • Study completion date: Mar 2029 to Mar 1, 2029
    • Site details revised at 2 of 160 sites
    v44
  22. Site details revised at 3 of 160 sitesv43
  23. Primary completion date: Jun 1, 2028 to Mar 2026
    • Study completion date: Dec 1, 2029 to Mar 2029
    v42
  24. Site details revised at 3 of 160 sitesv41
  25. Primary completion date: Mar 2026 to Jun 1, 2028
    • Study completion date: Mar 2029 to Dec 1, 2029
    v40
  26. Primary endpoints revised (2)
    • Study sites: 157 to 160
    • Eligibility criteria shortened, about 35 words
    • Secondary endpoints revised (25)
    v39
  27. Study title shortened, about 1 wordv38
  28. Primary endpoints revised (2)v37 Show 4 more changesShow less
    • Study sites: 160 to 157
    • Interventions: Lenalidomide (Combination Product), Placebo oral tablet (Drug), Rituximab (Combination Product), Tazemetostat (Drug) to Lenalidomide (Combination Product), Placebo oral tablet (Drug), Rituximab (Combination Product), Tazemetostat (Drug), Tazemetostat (Drug)
    • Eligibility criteria revised
    • Secondary endpoints: 6 to 25
  29. Study sites: 138 to 160v36
  30. Study sites: 132 to 138v35
  31. Study sites: 131 to 132v34
  32. Study sites: 127 to 131v33
  33. Study sites: 122 to 127v32
  34. Study sites: 107 to 122v31
  35. Primary completion date: Jun 2022 to Mar 2026v30 Show 6 more changesShow less
    • Primary endpoints revised (2)
    • Enrollment target: 518 to 540
    • Study sites: 63 to 107
    • Study completion date: Dec 2024 to Mar 2029
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints: 9 to 6
  36. Study sites: 53 to 63v29
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04224493
Lead Sponsor Epizyme, Inc.
Conditions
(from sponsor)		 Relapsed/Refractory Follicular Lymphoma, Follicular Lymphoma, Refractory Follicular Lymphoma
Related terms Lymphoma, Follicular
Enrollment 599 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov