Adult T-cell Leukemia/Lymphoma
Conditions
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).
Interventions
Once a day, 200 mg, oral administration
Sponsors
Daiichi Sankyo Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 ≥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 ≥ 3 months
Exclusion criteria
* A presence of central nervous system involvement at the time of screening tests * Have poorly controlled complication (eg. chronic congestive heart failure, unstable angina * ≥ 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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). |
| 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. |
| 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. |
| 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. |
| 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 |
Countries
Japan
Outcome results
None listed