Valemetostat Tosylate (DS-3201b) Phase 2 Study in Relapsed or Refractory Adult T-cell Leukemia/Lymphoma

• Status: Active, not recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daiichi Sankyo Co., Ltd.

Criteria

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