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
- Registration Number
- NCT05228158
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 145
- Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
- Participants treated with tazemetostat
- Participants with a history of hypersensitivity to any ingredient of Tazverik
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tazemetostat Tazemetostat 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.
- Primary Outcome Measures
Name Time Method Number of Participants With Serious ADRs Up to Week 52 Serious ADRs are defined as any untoward medical occurrence or effect that at any dose resulted in death or life-threatening conditions or required hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect or medically important condition.
Number of Participants With Adverse Drug Reactions (ADRs) Up to Week 52 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants with Overall Response Up to Week 52 Overall response rate is defined as a percentage of participants who achieved a best response including complete response (CR) or partial response (PR) based on Revised Response Criteria for Malignant Lymphoma (Cheson, 2007). CR: defined as disappearance of all target lesions, non-target lesions, no new lesions, and normalization of tumor marker level. PR: defined as at least a 30 percent (%) decrease in the sum of diameters of target lesions, no progression in non-target lesion, and no new lesions.
Number of Participants With ADRs Based on Participant Background Factors Up to Week 52 Number of participants with ADRs such as myelosuppression and infection based on participants background factors will be reported. Participant background factors will be sex, age, height, weight, clinical stage (Ann Arbor classification), the presence or absence of B symptoms, Eastern Cooperative Oncology Group Performance Status (ECOG-PS), complications, past history and history of drug allergy.
Trial Locations
- Locations (228)
Eisai Trial Site 210
🇯🇵Konan-shi, Aichi, Japan
Eisai Trial Site 217
🇯🇵Obu-shi, Aichi, Japan
Eisai Trial Site 238
🇯🇵Toyokawa-shi, Aichi, Japan
Eisai Trial Site 216
🇯🇵Yatomi-shi, Aichi, Japan
Eisai Trial Site 206
🇯🇵Matsudo-shi, Chiba, Japan
Eisai Trial Site 240
🇯🇵Fukuoka-shi, Fukuoka, Japan
Eisai Trial Site 243
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Eisai Trial Site 245
🇯🇵Kurume-shi, Fukuoka, Japan
Eisai Trial Site 236
🇯🇵Maebashi-shi, Gumma, Japan
Eisai Trial Site 234
🇯🇵Asahikawa-shi, Hokkaido, Japan
Scroll for more (218 remaining)Eisai Trial Site 210🇯🇵Konan-shi, Aichi, Japan