Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
- Registration Number
- NCT04102150
- Lead Sponsor
- Daiichi Sankyo Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- Participants with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) who have history of treatment with mogamulizumab or are mogamulizumab intolerant, contraindication after treatment with at least 1 medication regimen
- Aged β₯20 years or older at the time of signing the informed consent
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- At least 1 evaluable lesion
- Participants who have defined laboratory criteria
- Life expectancy β₯ 3 months
- A presence of central nervous system involvement at the time of screening tests
- Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina
- β₯ Grade 3 neuropathy
- QT interval corrected using Fridericia's method (QTcF) >470 ms
- Has an uncontrolled infection
- Participants who use corticosteroids over 10 mg/day
- Receipt of allogeneic hematopoietic stem cell transplantation
- History of, or concurrent, malignant tumors
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DS-3201b Valemetostat Tosylate -
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) assessed by central evaluation organization Through the end of the study (within approximately 5 years) 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.
- Secondary Outcome Measures
Name Time Method Tumor control rate (TCR) Through the end of the study (within approximately 5 years) The percentage of participants who were assessed for best overall response, who achieved CR, CRu, PR or stable disease (SD).
Best response per tumor lesions Through the end of the study (within approximately 5 years) Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Duration of response (DOR) Through the end of the study (within approximately 5 years) Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Overall response rate (ORR) assessed by investigator Through the end of the study (within approximately 5 years) The percentage of participants who were assessed for best overall response, who achieved CR, CRu, or PR by investigator.
Complete remission rate (CR rate) Through the end of the study (within approximately 5 years) The percentage of participants who were assessed for best overall response, who achieved CR or CRu.
Time to response (TTR) Through the end of the study (within approximately 5 years) Period from the first day of DS-3201b dose to the first day of CR, CRu, or PR
Progression-free survival (PFS) Through the end of the study (within approximately 5 years) Period from the first day of DS-3201b dose to the day of RD/PD or death.
Overall survival (OS) Through the end of the study (within approximately 5 years) Period from the first day of DS-3201b dose to death.
Trial Locations
- Locations (24)
Nagoya City University Hospital
π―π΅Nagoya-shi, Aichi, Japan
Local Incorporated Administrative Agency Sasebo City General Hospital
π―π΅Sasebo-shi, Nagasaki, Japan
Osaka International Cancer Institute
π―π΅Osaka-shi, Osaka, Japan
Imamura General Hospital
π―π΅Kagoshima-shi, Kagoshima, Japan
Kyushu University Hospital
π―π΅Fukuoka-shi, Fukuoka, Japan
Ehime University Hospital
π―π΅TΕon-shi, Ehime, Japan
Kumamoto University Hospital
π―π΅Kumamoto-shi, Kumamoto, Japan
National University Corporation Tohoku University Tohoku University Hospital
π―π΅Sendai-shi, Miyagi, Japan
University of the Ryukyus Hospital
π―π΅Nakagami-gun, Okinawa, Japan
Saga University Hospital
π―π΅Saga-shi, Saga, Japan
National Hospital Organization Kyushu Cancer Center
π―π΅Fukuoka-shi, Fukuoka, Japan
Osaka University Hospital
π―π΅Suita-shi, Osaka, Japan
Nagasaki University Hospital
π―π΅Nagasaki-shi, Japan
Saitama Medical University International Medical Center
π―π΅Hidaka-shi, Saitama, Japan
Hokkaido University Hospital
π―π΅Sapporo-shi, Hokkaido, Japan
Hamamatsu University Hospital
π―π΅Hamamatsu-shi, Shizuoka, Japan
Kagoshima University Hospital
π―π΅Kagoshima-city, Japan
National Cancer Center Hospital East
π―π΅Kashiwa-shi, Chiba, Japan
Kochi Medical School Hospital
π―π΅Nankoku-shi, Kochi, Japan
University of Miyazaki Hospital
π―π΅Miyazaki-shi, Miyazaki, Japan
Okayama University Hospital
π―π΅Okayama-shi, Okayama, Japan
Kindai University Hospital
π―π΅Osakasayama-shi, Osaka, Japan
National Cancer Center Hospital
π―π΅Chuo Ku, Tokyo, Japan
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
π―π΅Minato-Ku, Tokyo, Japan