Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule
Acute myeloid leukemia is a disease in which characterised by blast further than 20% in bone
marrow plus incomplete differentiation. Many of this patients are elderly with age further
than 60 years(CALGB,ECOG,EORTC) or 55 years (SWOG). Mortality rate fallowing standard
therapy of this patients is high that can reach to 50%. One of methods to apply a remission
with least mortality and morbidity and also significant lower cost effects compare to
historical and conventional standard regimen is low dose cytosar and arsenic trioxide
combination that has been reported complete remission to 34%.
We select ten patients with age further than 60 with comorbidity and treat by low dose
cytosar subcutaneous plus arsenic trioxide for ten days in month. We will assess overall
response rate and overall survival in end of one year.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
1, 2, 6 month and one year after intervention
No
Kamran Alimoghaddam, M.D.
Study Director
Hematology-Oncology and SCT Research Center
Iran: Ministry of Health
87-02-36-7242
NCT00850304
October 2007
February 2008
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