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| ID | Type | Description | Link |
|---|---|---|---|
| 194964 | Other Identifier | JAPIC CTI |
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This Phase 2 study will be conducted to assess the efficacy and safety of valemetostat tosylate (DS-3201b) in participants with relapsed or refractory adult T-cell leukemia/lymphoma (r/r ATL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS-3201b | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valemetostat Tosylate | Drug | Once a day, 200 mg, oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) assessed by central evaluation organization | The percentage of participants who were assessed for best overall response, who achieved complete remission (CR), complete remission, unconfirmed (CRu) or partial remission (PR) by central evaluation organization. | Through the end of the study (within approximately 5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) assessed by investigator | The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator. | Through the end of the study (within approximately 5 years) |
| Best response per tumor lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Study Leader | Daiichi Sankyo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital | Nagoya | Aichi-ken | Japan | |||
| National Cancer Center Hospital East |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36150143 | Derived | Izutsu K, Makita S, Nosaka K, Yoshimitsu M, Utsunomiya A, Kusumoto S, Morishima S, Tsukasaki K, Kawamata T, Ono T, Rai S, Katsuya H, Ishikawa J, Yamada H, Kato K, Tachibana M, Kakurai Y, Adachi N, Tobinai K, Yonekura K, Ishitsuka K. An open-label, single-arm phase 2 trial of valemetostat for relapsed or refractory adult T-cell leukemia/lymphoma. Blood. 2023 Mar 9;141(10):1159-1168. doi: 10.1182/blood.2022016862. |
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De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
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Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions. |
| Through the end of the study (within approximately 5 years) |
| Complete remission rate (CR rate) | The percentage of participants who were assessed for best overall response, who achieved CR or CRu. | Through the end of the study (within approximately 5 years) |
| Tumor control rate (TCR) | The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD). | Through the end of the study (within approximately 5 years) |
| Time to response (TTR) | Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR | Through the end of the study (within approximately 5 years) |
| Duration of response (DOR) | Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death. | Through the end of the study (within approximately 5 years) |
| Progression-free survival (PFS) | Period from the first day of DS-3201b dose to the day of RD/PD or death. | Through the end of the study (within approximately 5 years) |
| Overall survival (OS) | Period from the first day of DS-3201b dose to death. | Through the end of the study (within approximately 5 years) |
| Kashiwa-shi |
| Chiba |
| Japan |
| Ehime University Hospital | Tōon-shi | Ehime | Japan |
| Kyushu University Hospital | Fukuoka | Fukuoka | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | Fukuoka | Japan |
| Hokkaido University Hospital | Sapporo | Hokkaido | Japan |
| Imamura General Hospital | Kagoshima | Kagoshima-ken | Japan |
| Kochi Medical School Hospital | Nankoku-shi | Kochi | Japan |
| Kumamoto University Hospital | Kumamoto | Kumamoto | Japan |
| National University Corporation Tohoku University Tohoku University Hospital | Sendai | Miyagi | Japan |
| University of Miyazaki Hospital | Miyazaki | Miyazaki | Japan |
| Local Incorporated Administrative Agency Sasebo City General Hospital | Sasebo-shi | Nagasaki | Japan |
| Okayama University Hospital | Okayama | Okayama-ken | Japan |
| University of the Ryukyus Hospital | Nakagami-gun | Okinawa | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | Japan |
| Kindai University Hospital | Osakasayama-shi | Osaka | Japan |
| Osaka University Hospital | Suita-shi | Osaka | Japan |
| Saga University Hospital | Saga | Saga-ken | Japan |
| Saitama Medical University International Medical Center | Hidaka-shi | Saitama | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | Japan |
| National Cancer Center Hospital | Chuo Ku | Tokyo | Japan |
| IMSUT Hospital, The Institute of Medical Science, The University of Tokyo | Minato-Ku | Tokyo | Japan |
| Kagoshima University Hospital | Kagoshima | Japan |
| Nagasaki University Hospital | Nagasaki | Japan |
| ID | Term |
|---|---|
| D054218 | Precursor T-Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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