A Study of Tazemetostat on Safety in Subject With Relapsed or Refractory Follicular Lymphoma With Enhancer of Zeste Homolog 2 (EZH2) Gene Mutation in Japa

Phase 1

• Conditions: ymphoma, Follicular; MedDRA version: 24.0Level: PTClassification code 10085128Term: Follicular lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2021-006398-41-Outside-EU/EEA
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-27
• Last Update Posted: 1 February 2022

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified