Adult T-cell leukemia/lymphoma: ATL
Conditions
Interventions
investigational material(s)
Generic name etc : Valemetostat tosylate
INN of investigational material : Valemetostat tosylate
Therapeutic category code : 429 Other antitumor agents
Dosage and Administr
Sponsors
DAIICHI SANKYO Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with relapsed or refractory 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 - Subject who has defined laboratory criteria - Life expectancy >= 3 months.
Exclusion criteria
Exclusion criteria: - A presence of central nervous system involvement at the time of screening tests. - Have poorly controlled complication (ex. Chronic congestive heart failure, unstable angina) - >= Grade 3 neuropathy. - QTcF >470 ms - Has an uncontrolled infection. - Subject who use of corticosteroids over 10 mg/day - Receipt of allogeneic hematopoietic stem cell transplantation. - History of, or concurrent, malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy ORR assessed by central evaluation organization | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy pharmacokinetics pharmacodynamics pharmacogenomics other - ORR assessed by investigator/sub-investigator - Best response per tumor lesions - CR rate - TCR - TTR - DOR - PFS - OS - Safety - Pharmacokinetics - Pharmacodynamics | — |
Countries
Japan
Contacts
Public ContactContact for Clinical Trial Information
DAIICHI SANKYO Co.,Ltd.
Outcome results
None listed