Continuous administration trial of phase II study of BSC-1 in patients with AT
Phase 2
Completed
- Conditions
- Adult T-cell leukemia/lymphoma
- Registration Number
- JPRN-jRCT2080224825
- Lead Sponsor
- Minophagen Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 10
Inclusion Criteria
1. Patients who participated in and completed the B-1801 trial.
2. Patients who can agree to use effective contraception method.
Fertile female subject:
During study drug administration and 1 month after completion of study drug administration.
Male subjects with pregnant women as partners:
During study drug administration and 3 months after completion of study drug administration.
3. Patient who agreed in writing about participation in this trial by last visit of the B-1801 trial.
Exclusion Criteria
1. Patients who evaluated the efficacy at PD by mSWAT or the modified response criteria for ATL at last visit of the B-1801 trial.
2. On other, patients judged not to be appropriate for participation in the trial by investigators.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse event<br>Incidence<br>Severity (grade)<br>Relevance with investigational drug
- Secondary Outcome Measures
Name Time Method efficacy<br>Best overall response rate<br>Response duration<br>Time to response<br>Disease control rate<br>Time to progression<br>Incidence of acute transformation