Adult T-cell leukemia/lymphoma
Conditions
Sponsors
Minophagen Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse event Incidence Severity (grade) Relevance with investigational drug | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Best overall response rate Response duration Time to response Disease control rate Time to progression Incidence of acute transformation | — |
Countries
Japan
Outcome results
None listed