Phase II trial of combination therapy with arsenic trioxide and conventional chemotherapy for patients with relapsed or refractory adult T-cell leukemia (ATL)
Phase 2
- Conditions
- Adult T-cell leukemia
- Registration Number
- JPRN-UMIN000007059
- Lead Sponsor
- Kagoshima University Hospital, Dept. Hematology and Immunology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 7
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method response rate
- Secondary Outcome Measures
Name Time Method adverse event incidence rate