{"preliminary_commentary":{"by_channel":{"podcast":6,"x_thread":4,"youtube":2},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":true,"how":"POST https://www.erudio.com/api/trial-requests with {\"nct_id\": \"NCT04224493\", \"email\": \"<work email>\"}. The person who owns that inbox must confirm by the emailed link; agents cannot confirm. The result is the report's free public preview; the full report is still bought."},"commentary_summary":null,"drugs_tested":[["tazemetostat"]],"indication":"relapsed/refractory follicular lymphoma","name":"SYMPHONY-1","nct_id":"NCT04224493","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=symphony-1-nct04224493. The price is an estimate of verified statements from the commentary indexed so far, fixed at order. Final coverage is set when the report is built. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_usd":1250,"size":"standard","size_rule":"Standard: 151–300 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"SYMPHONY-1","arms":[{"description":"Stage 1 (Phase 1b): completed\n\n* Tazemetostat escalated 400mg PO twice daily to 600mg PO twice daily (BD) to 800mg PO BD in 28-day cycles\n* Rituximab 375mg/m2 IV on days 1, 8, 15, \\& 22 of cycle 1; then on day 1 of cycles 2-5\n* Lenalidomide 20mg or 10mg, administered PO QD on days 1-21 for 12 cycles\n\nStage 2:\n\n* Tazemetostat 800mg administered PO BD in continuous 28-day cycles.\n* Rituximab 375mg/m2 IV on days 1, 8, 15, \\& 22 of cycle 1; then on day 1 of cycles 2-5\n* Lenalidomide 20mg or 10mg, administered PO QD on days 1-21 for 12 cycles\n\nMaintenance Therapy (Stages 1\\&2):\n\nTazemetostat 800mg PO BD dose for up to 2 years after the initial 12 months of combination therapy. Following an Independent Data Monitoring Committee review, an urgent safety measure was implemented and administration of tazemetostat was permanently discontinued. No further investigational treatment is administered. Participants previously exposed to tazemetostat enter protocol-specified long-term safety follow-up","label":"Tazemetostat + R2 arm","type":"EXPERIMENTAL"},{"description":"Participants were assigned to receive placebo in combination with lenalidomide and rituximab.\n\nFollowing implementation of the urgent safety measure, placebo administration was permanently discontinued. No further investigational treatment is administered.\n\nStage 2:\n\n* Placebo administered PO twice daily in continuous 28-day cycles.\n* Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.\n* Lenalidomide 20 mg or 10 mg (if creatinine clearance ≥60 mL/minute or \\<60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.\n\nMaintenance Therapy (Stage 2):\n\nPlacebo will be administered as monotherapy twice daily dose for up to 2 years after the initial 12 months of combination therapy. During maintenance, placebo will be continued until disease progression or unacceptable toxicity, or participant withdraws consent.","label":"Placebo + R2 Arm","type":"PLACEBO_COMPARATOR"}],"collaborators":[],"completion_date":{"date":"2029-03-01","type":"ESTIMATED"},"conditions":["Relapsed/Refractory Follicular Lymphoma","Follicular Lymphoma","Refractory Follicular Lymphoma"],"enrollment":{"count":599,"type":"ACTUAL"},"has_results":false,"interventions":[{"name":"Tazemetostat","otherNames":["EPZ-6438","IPN60200"],"type":"DRUG"},{"name":"Tazemetostat","otherNames":["EPZ-6438","IPN60200"],"type":"DRUG"},{"name":"Placebo oral tablet","otherNames":[],"type":"DRUG"},{"name":"Lenalidomide","otherNames":[],"type":"COMBINATION_PRODUCT"},{"name":"Rituximab","otherNames":[],"type":"COMBINATION_PRODUCT"}],"last_update":"2026-10-05","lead_sponsor":"Epizyme, Inc.","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","overall_status":"ACTIVE_NOT_RECRUITING","phases":["PHASE3"],"primary_completion_date":{"date":"2027-02-13","type":"ESTIMATED"},"primary_outcomes":[{"measure":"Phase 1b: Recommended Phase 3 Dose (RP3D) of tazemetostat in combination with rituximab and lenalidomide (R2)","timeFrame":"Subjects are evaluated for DLTs during the first 28-day cycle. The RP3D for Phase 3 was selected at the end of Stage 1"},{"measure":"Phase 3: Progression-Free Survival (PFS) in the Intent-to-treat wild-type (ITT-WT) populations","timeFrame":"Stage 2: Up to 72 months"},{"measure":"Phase 3: PFS in the Intent-to-treat mutant-type (ITT-MT) population","timeFrame":"Stage 2: Up to 72 months"},{"measure":"Phase 3: PFS in the R/R FL population regardless of mutation status by Investigator assessment","timeFrame":"Stage 2: Up to 72 months"},{"measure":"Phase 3: Progression-Free Survival (PFS) in the all comer (ITT-All) populations.","timeFrame":"Stage 2: Up to 72 months"}],"references":[{"citation":"Cao J, Chen G, Qiu L, Zhang L, Jiang M, Cheng Y, Zhang Q, Liu L, Li P, Shuang Y, Wang H, Xue H, Wu H, Zheng M, Zhou K, Li Z, Jing H, Yang W, Zhu Z, Li W, Wangwu J, Huang H, Jia Q, Chen D, Fan S, Shi MM, Su W. Efficacy and safety of tazemetostat, an EZH2 inhibitor, in Chinese patients with relapsed/refractory follicular lymphoma: a multicentre, single-arm, phase 2 study. EClinicalMedicine. 2025 Aug 18;87:103399. doi: 10.1016/j.eclinm.2025.103399. eCollection 2025 Sep.","pmid":"40896460","type":"DERIVED"}],"start_date":{"date":"2020-06-11","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"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.","url":"https://clinicaltrials.gov/study/NCT04224493"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.1","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/symphony-1-nct04224493"}