Valemetostat Tosylate (DS-3201b) Phase 2 study in relapsed or refractory adult T-cell leukemia/lymphoma
- Conditions
- Adult T-cell leukemia/lymphoma: AT
- Registration Number
- JPRN-jRCT2080224880
- Lead Sponsor
- DAIICHI SANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 25
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>ORR assessed by central evaluation organization
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>other<br>- ORR assessed by investigator/sub-investigator<br>- Best response per tumor lesions<br>- CR rate<br>- TCR<br>- TTR<br>- DOR<br>- PFS<br>- OS<br>- Safety<br>- Pharmacokinetics<br>- Pharmacodynamics