Adult T-cell leukemia
Conditions
Interventions
1) arsenic trioxide (ATO) (0.15 mg/kg div. on days 1-5 of weeks 1) 2) RCM regimen, each cycle is 28 days 1)+2) is repeated 2 cycles.
Sponsors
Kagoshima University Hospital, Dept. Hematology and Immunology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Peripheral T-cell lymphoma diagnosed hematologically/pathologically and proven by FCM analysis. 2) HTLV-1 Ab positive. 3) acute, lymphoma and chronic type ATL with unfavorable factors 4) Aged 20 to 75 years old 5) Performance status (PS) of 0-3 on ECOG scale 6) Relapsed or refractory ATL patients after one or more prior lines of chemotherapy 7) Adequate hematological and major organ function 8) Written informed consent 9) more than 2 weeks of interval from last chemotherapy for ATL to scheduled first day of protocol treatment
Exclusion criteria
Exclusion criteria: 1) history of glaucoma 2) uncontrollable DM (under insulin therapy) 3) treated cardiac disease, coronary artery disease, cardiomyopathy, heart failure and severe arrthythmia 4) HIV-Ab positive, HCV-Ab positive, HBs -Ag positive 5) interstitial pneumonia, pulmonary fibrosis, severe emphysema 6) acute hepatitis, chronic hepatitis, liver cirrhosis 7) synchronous or metachronous malignancy, history of malignant lymphoma, myelodysplastic syndrome and acute leukemia 8) pregnant or nursing women 9) psychological disturbance 10) hypersensitivity to arsenic trioxide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse event incidence rate | — |
Countries
Japan
Contacts
Public ContactUOZUMI Kimiharu
Kagoshima University Hospital Dept. Hematology and Immunology
Outcome results
None listed