Adult T-cell leukemia (ATL)
Conditions
Interventions
abacavir 1800mg/day endpoints are assessed during first 12 weeks of treatment
Sponsors
Kyoto University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: acute-, lymphoma- or unfavorable chronic-type adult T-cell leukemia. relapsed after, or refractory to at least one standard chemotherapy regimen. with at least one measurable lesion, or skin or peripheral blood involvement. with adequate cardiac, pulmonary, renal and liver function.
Exclusion criteria
Exclusion criteria: prior treatment with abacavir or AZT pregnant or lactating women. active malignancy other than ATL. previous treatment with autologous or allogeneic transplantation. positive for HBs antigen. positive for anti-HBs antibody or anti-HBc antibody and HBV-DNA. positive for anti-HIV antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response proportion during first 12 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, time-to-treatment-failure, disease control rate, the frequency and grade of adverse events, response proportion accrding to disease subtype, pharmacokinetics | — |
Countries
Japan
Contacts
Public ContactMasakatsu Hishizawa
Kyoto University Hospital Department of Hematology/Oncology
Outcome results
None listed