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A Study of Tazemetostat on Safety in Subject 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

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-006398-41-Outside-EU/EEA
Enrollment
Unknown
Registered
2022-01-27
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphoma, Follicular MedDRA version: 24.0 Level: PT Classification code 10085128 Term: Follicular lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Tazverik Product Name: Tazemetostat Pharmaceutical Form: Tablet INN or Proposed INN: Tazemetostat Current Sponsor code: E7438 Concentration unit: mg milligram(s) Concentration type: equal

Sponsors

Eisai Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects with with relapsed or refractory follicular lymphoma with EZH2 gene mutation. 2. Subjects treated with tazemetostat. Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 44 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: 1. Subjects with a history of hypersensitivity to any ingredient of Tazverik.

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the safety of tazemetostat in subjects with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.;Secondary Objective: 1. To investigate the factors affecting the incidence of adverse drug reactions falling under “myelosuppression” and “infection” after treated with tazemetostat in subjects with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice. 2. To investigate the efficacy of tazemetostat in subjects with relapsed or refractory follicular lymphoma with EZH2 gene mutation under daily clinical practice.;Primary end point(s): 1. Number of Subjects With Adverse Drug Reactions (ADRs) 2. Number of Subjects With Serious ADRs;Timepoint(s) of evaluation of this end point: Up to Week 52—

Secondary

MeasureTime frame
Secondary end point(s): 1. Number of Subjects With ADRs Based on Subjects Background Factors 2. Percentage of Subjects With Overall Response;Timepoint(s) of evaluation of this end point: Up to Week 52—

Countries

Japan

Contacts

Public ContactClinical Planning Development Dept.

Eisai Co., Ltd.

eisai-chiken_hotline@hhc.eisai.co.jp

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026