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

Daiichi Sankyo

Status and phase: Completed; Phase 2

Conditions: Adult T-cell Leukemia/Lymphoma

Treatments: Drug: Valemetostat Tosylate

Study type: Interventional

Funder types: Industry

Identifiers

NCT04102150

DS3201-A-J201

194964 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

DS-3201b

Experimental group

Treatment:

Drug: Valemetostat Tosylate