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

Phase 2

Completed

• Conditions: Leukemia, Myeloid, Acute
• Interventions: Drug: Cytosar; Drug: Arsenic trioxide

• Registration Number: NCT00850304
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Status Verified: 2009-02
• Study First Submitted: 2009-02-21
• Study First Submitted QC: 2009-02-21
• Last Update Submitted: 2009-02-21
• Study First Posted: 2009-02-24
• Last Update Posted: 2009-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm one	Cytosar	-
Arm one	Arsenic trioxide	-

Primary Outcome Measures

Name	Time	Method
Response Rate	1, 2, 6 month and one year after intervention

Secondary Outcome Measures

Name	Time	Method
Overall Survival	One year after intervention

Trial Locations

Locations (1)

Hematology-Oncology and SCT Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of