Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Feasibility Study of Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide on Ambulatory Schedule

Conditions
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Leukemia, Myeloid, Acute

Intervention / Treatment
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* Drug: Cytosar
* Drug: Arsenic trioxide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elderly patients with non promyelocytic AML Performance status (ECOG) 3 or 4 Exclusion Criteria: Age <60 years Elevation of AST OR ALT more than ten times above normal Serum bilirubin above 5 Cr level > 2

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm one<br> | Drug: Cytosar<br>* Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle<br>Drug: Arsenic trioxide<br>* Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11<br>* Other names: ATO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  | 1, 2, 6 month and one year after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | One year after intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML