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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Once a day, 200 mg, oral administration
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
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.
Time frame: Through the end of the study (within approximately 5 years)
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.
Time frame: Through the end of the study (within approximately 5 years)
Best response per tumor lesions
Best response in target lesions (nodal or extranodal lesions), peripheral blood lesions, and skin lesions.
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: Through the end of the study (within approximately 5 years)
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National Cancer Center Hospital East
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
...and 14 more locations
Duration of response (DOR)
Period from first CR, CRu, or PR to residual disease/progressive disease (RD/PD) or death.
Time frame: 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.
Time frame: Through the end of the study (within approximately 5 years)
Overall survival (OS)
Period from the first day of DS-3201b dose to death.
Time frame: Through the end of the study (within approximately 5 years)