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
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Tazemetostat
Tazemetostat oral tablets.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
Secondary Outcome Measures
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants with relapsed or refractory follicular lymphoma with EZH2 gene mutation
-
Participants treated with tazemetostat
Exclusion Criteria:
- Participants with a history of hypersensitivity to any ingredient of Tazverik
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Eisai Trial Site 10 | Fukuoka-shi | Fukuoka | Japan | |
| 2 | Eisai Trial Site 5 | Muroran-shi | Hokkaido | Japan | |
| 3 | Eisai Trial Site 21 | Nishinomiya-shi | Hyogo | Japan | |
| 4 | Eisai Trial Site 17 | Kagoshima-shi | Kagoshima | Japan | |
| 5 | Eisai Trial Site 4 | Yokohama-shi | Kanawaga | Japan | |
| 6 | Eisai Trial Site 15 | Kyoto-shi | Kyoto | Japan | |
| 7 | Eisai Trial Site 18 | Matsusaka-shi | Mie | Japan | |
| 8 | Eisai Trial Site 3 | Kurashiki-shi | Okayama | Japan | |
| 9 | Eisai Trial Site 2 | Maniwa-shi | Okayama | Japan | |
| 10 | Eisai Trial Site 20 | Okayama-shi | Okayama | Japan | |
| 11 | Eisai Trial Site 7 | Okayama-shi | Okayama | Japan | |
| 12 | Eisai Trial Site 8 | Okayama-shi | Okayama | Japan | |
| 13 | Eisai Trial Site 9 | Nakagami-gun | Okinawa | Japan | |
| 14 | Eisai Trial Site 12 | Osakasayama-shi | Osaka | Japan | |
| 15 | Eisai Trial Site 19 | Izunokuni-shi | Shizuoka | Japan | |
| 16 | Eisai Trial Site 13 | Nagaizumi-cho | Shizuoka | Japan | |
| 17 | Eisai Trial Site 1 | Chuo-ku | Tokyo | Japan | |
| 18 | Eisai Trial Site 16 | Koto-ku | Tokyo | Japan | |
| 19 | Eisai Trial Site 14 | Shinagawa-Ku | Tokyo | Japan | |
| 20 | Eisai Trial Site 11 | Sakata-shi | Yamagata | Japan | |
| 21 | Eisai Trial Site 6 | Sakata-shi | Yamagata | Japan |
Sponsors and Collaborators
- Eisai Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- E7438-M081-501