A Phase 2 interventional study of Cytosar and Arsenic trioxide in Leukemia, Myeloid, Acute, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2009-02-24.
Sponsored by Tehran University of Medical Sciences · Phase 2, Interventional, and Treatment
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic Acute myeloid leukaemia on elderly patients. 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.
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 10 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Drug: Cytosar · Drug: Arsenic trioxide
Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle
Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
Also known as: ATO
Response Rate
Time frame: 1, 2, 6 month and one year after intervention
Overall Survival
Time frame: One year after intervention
This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.
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Tehran University of Medical Sciences