Clinical trial · Observational
A Study of Tazemetostat on Safety in Participants With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japan
A Post-marketing Observational Study of Tazemetostat on Safety in Patients With Relapsed or Refractory Follicular Lymphoma With EZH2 Gene Mutation in Japan
NCT05228158CI-TRIAL-00100044active not recruitingClinicalTrials.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)
The primary purpose of the study is to investigate the safety of tazemetostat in participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.
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 |
|---|---|---|---|
| Lymphoma, Follicular | Follicular Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tazemetostat | Drug | Tazemetostat | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Tazemetostat
- description
- Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation will receive Tazemetostat 800 milligram (mg), tablet, orally, twice daily or as per physicians discretion in routine clinical practice. All the participants will be observed for up to Week 52 prospectively.
- interventionNames
- Drug: Tazemetostat
Primary outcomes (2)
- measure
- Number of Participants With Adverse Drug Reactions (ADRs)
- timeFrame
- Up to Week 52
- description
- An ADR is defined as harmful and unintended responses to the normal administration/use of drugs, in which a causal relationship with the drug in question cannot be ruled out. Adverse events (AEs) with unknown causality to the drug among those voluntarily reported will be also considered ADRs.
- measure
- Number of Participants With Serious ADRs
- timeFrame
- Up to Week 52
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation 2. Participants treated with tazemetostat Exclusion Criteria: 1\. Participants with a history of hypersensitivity to any ingredient of Tazverik
References
Publications (0)
Data not yet available
No reference posted for this study.