Clinical trial · Interventional
Tazemetostat for the Treatment of Relapsed/Refractory Follicular Lymphoma
A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Tazemetostat for the Treatment of Patients With Relapsed/Refractory Follicular Lymphoma
NCT05467943CI-TRIAL-00085007completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Treating Relapsed/Refractory Follicular Lymphoma with Tazemetostat
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Follicular Lymphoma With EZH2 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tazemetostat | Drug | Tazemetostat | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cohort 1 based on the EZH2 mutations
- description
- MT patients with R/R FL; planned enrollment number: 19;
- interventionNames
- Drug: Tazemetostat
- type
- EXPERIMENTAL
- label
- Cohort 2 based on the EZH2 mutations,
- description
- WT patients with R/R FL; planned enrollment number: 20;
- interventionNames
- Drug: Tazemetostat
Primary outcomes (1)
- measure
- efficacy of Tazemetostat in EZH2 (MT) (Cohort 1)
- timeFrame
- 22 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Fully aware this study and signed the informed consent form in voluntary manner, and willing and able to comply with the study procedure; 2. Age ≥18 years; 3. Patients with histologically confirmed R/R FL (Grades 1, 2, 3a) 4. Patients must have one measurable lesion 5. Life expectancy ≥ 12 weeks; 6. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2 7. Adequate bone marrow function, renal function and hepatic function: 8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) or cytomegalovirus (CMV) is inactive: 9. Female patients of childbearing potential must agree to adopt dual contraceptive method Exclusion Criteria: 1. Previous use of Tazemetostat or other EZH2 inhibitors; 2. Patients with invasion of lymphoma to the central nervous system (CNS) or the pia mater; 3. Previous bone marrow malignancies, 4. Abnormalities associated with MDS and myeloproliferative neoplasms observed by cytogenetic testing and DNA sequencing;
References
Publications (1)
- DERIVEDCao 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