Status:
COMPLETED
Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma
Lead Sponsor:
Daiichi Sankyo Co., Ltd.
Conditions:
Adult T-cell Leukemia/Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2024
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04102150
Start Date
November 21 2019
End Date
October 27 2024
Last Update
February 10 2025
Active Locations (24)
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1
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
2
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
3
Ehime University Hospital
Tōon-shi, Ehime, Japan
4
Kyushu University Hospital
Fukuoka, Fukuoka, Japan