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

Tehran University of Medical Sciences

Status and phase: Completed; Phase 2

Conditions: Leukemia, Myeloid, Acute

Treatments: Drug: Arsenic trioxide; Drug: Cytosar

Study type: Interventional

Funder types: Other

Identifiers

NCT00850304

87-02-36-7242

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Arm one

Experimental group

Treatment:

Drug: Cytosar

Drug: Arsenic trioxide