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NCT04762160
SYMPHONY-2, A Trial to Examine Combination of Tazemetostat With Rituximab in Subjects With Relapsed/Refractory Follicular Lymphoma
Phase 2 trial testing Tazemetostat in Follicular Lymphoma in 5 participants. Terminated before completion.
22 March 2022
Quick facts
| Lead sponsor | Epizyme, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 15 December 2020 |
| Primary completion | 22 March 2022 |
| Estimated completion | 22 March 2022 |
| Sites | 20 locations across United States |
Drugs / interventions tested
- Tazemetostat (tazemetostat) — full drug profile →
- Rituximab — full drug profile →
Conditions studied
- Follicular Lymphoma — all drugs for Follicular Lymphoma →
Sponsor
Epizyme, Inc. — full company profile →
Who can join
18 and older, any sex, with Follicular Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events were assessed from the date of first dose of study treatment (Day 1) until 30 days after discontinuation of study treatment (approximately 462 days).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (4 terms)
| Reaction | System | Tazmetostat in Combination… |
|---|---|---|
| Gastrointestinal haemorrhage | Gastrointestinal disorders | — |
| Cardiac failure acute | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
Other adverse events (30 terms — click to expand)
| Reaction | System | Tazmetostat in Combination… |
|---|---|---|
| Infusion related reaction | Injury, poisoning and procedural complications | — |
| Blood creatinine increased | Investigations | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Cardiomegaly | Cardiac disorders | — |
| Ear pain | Ear and labyrinth disorders | — |
| Foreign body sensation in eyes | Eye disorders | — |
| Headache | Nervous system disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Contusion | Injury, poisoning and procedural complications | — |
| Haematochezia | Gastrointestinal disorders | — |
| Flank pain | Musculoskeletal and connective tissue disorders | — |
| Urinary tract infection | Infections and infestations | — |
| Testicular oedema | Reproductive system and breast disorders | — |
| Groin pain | Musculoskeletal and connective tissue disorders | — |
| Impetigo | Infections and infestations | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Nephrolithiasis | Renal and urinary disorders | — |
| Microcytic anaemia | Blood and lymphatic system disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — |
| Fall | Injury, poisoning and procedural complications | — |
| Brachial plexopathy | Nervous system disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Joint swelling | Musculoskeletal and connective tissue disorders | — |
| Fatigue | General disorders | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | — |
Most-reported serious reactions: Gastrointestinal haemorrhage, Cardiac failure acute, Myocardial infarction, Abdominal pain.
Data from ClinicalTrials.gov NCT04762160 adverse events section.
Sponsor's own description
This study evaluates the safety and efficacy of combining the EZH2 inhibitor tazemetostat with rituximab in R/R FL subjects previously treated with at least 2 standard prior systemic treatment regimens where at least 1 anti-CD20-based regimen was used.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The roles of EZH2 in cancer and its inhibitors.
Liu Y, Yang Q. · · 2023 · cited 100× · PMID 37148376 · DOI 10.1007/s12032-023-02025-6 -
Mechanisms of immune modulation in the tumor microenvironment and implications for targeted therapy.
Czajka-Francuz P, Prendes MJ, Mankan A, Quintana Á, et al · · 2023 · cited 46× · PMID 37427115 · DOI 10.3389/fonc.2023.1200646 -
Regulatory T cells in homeostasis and disease: molecular mechanisms and therapeutic potential.
Wang L, Liang Y, Zhao C, Ma P, et al · · 2025 · cited 26× · PMID 41087343 · DOI 10.1038/s41392-025-02326-4 -
Follicular Lymphoma: a Focus on Current and Emerging Therapies
Cahill KE, Smith SM. · · 2022 · cited 25× · PMID 35180337 · DOI 10.46883/2022.25920946 -
Evolving therapeutic landscape in follicular lymphoma: a look at emerging and investigational therapies.
Hanel W, Epperla N. · · 2021 · cited 22× · PMID 34193230 · DOI 10.1186/s13045-021-01113-2 -
Innovative approaches for treatment of osteosarcoma.
Rothzerg E, Pfaff AL, Koks S. · · 2022 · cited 21× · PMID 35043695 · DOI 10.1177/15353702211067718 -
Novel insights into histone lysine methyltransferases in cancer therapy: From epigenetic regulation to selective drugs.
Liao Q, Yang J, Ge S, Chai P, et al · · 2023 · cited 19× · PMID 36908859 · DOI 10.1016/j.jpha.2022.11.009 -
Epigenetic, Metabolic, and Immune Crosstalk in Germinal-Center-Derived B-Cell Lymphomas: Unveiling New Vulnerabilities for Rational Combination Therapies.
Serganova I, Chakraborty S, Yamshon S, Isshiki Y, et al · · 2021 · cited 19× · PMID 35071240 · DOI 10.3389/fcell.2021.805195
Verify or expand the search:
- PubMed search for NCT04762160
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tazemetostat
Trials testing the same drug.
- NCT06575686 — Epcoritamab and Tazemetostat for the Treatment of Relapsed or Refractory Grade I-IIIa Follicular Lymphoma · Phase 2 · suspended
- NCT06692452 — Tazemetostat Plus CHOP in 1L T-cell Lymphoma · Phase 2 · withdrawn
- NCT06242834 — Pembrolizumab and Tazemetostat to Overcome Immune Tolerance Following ASCT or CAR T-cell Therapy in Patients With Aggres · Phase 2 · active not recruiting
- NCT05983965 — Study of Tazemetostat in Lymphoid Malignancies · Phase 1 · terminated
- NCT05151588 — Induction Chemotherapy and Tazemetostat for Locally Advanced SMARCB1-deficient Sinonasal Carcinoma · Phase 2 · not yet recruiting
Other recruiting trials for Follicular Lymphoma
Currently open trials in the same condition.
- NCT07128641 — Odronextamab in Low Tumor Volume Advanced FL · Phase 2 · recruiting
- NCT06792825 — HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL · Phase 2 · recruiting
- NCT06911502 — A Study to Compare the Efficacy and Safety of Golcadomide in Combination With Rituximab (Golca + R) vs Investigator's Ch · Phase 3 · recruiting
- NCT07126678 — Fixed-Duration Zanubrutinib, Bendamustine, and Obinutuzumab (ZBG) in Treatment-Naïve Advanced Stage Follicular Lymphoma · NA · recruiting
- NCT06860880 — Combating Cancer-Related Fatigue: A Personalized Supportive Care Program · NA · recruiting
Other Epizyme, Inc. trials
Trials by the same sponsor.
- NCT06068881 — A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lym · Phase 2 · withdrawn
- NCT05121103 — A Study of the Safety, Tolerability and Effectiveness of EZM0414 (IPN60210) Investigative Product in Participants With R · Phase 1 · terminated
- NCT05205252 — A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. · Phase 1, PHASE2 · withdrawn
- NCT04224493 — A Study to Assess the Efficacy, Safety, Pharmacodynamics, and Pharmacokinetics of Tazemetostat in Combination With Lenal · Phase 3 · recruiting
- NCT04537715 — Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04762160 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Epizyme, Inc.
- Last refreshed: 25 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04762160.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing