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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00850304
• Other study ID #: 87-02-36-7242
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2009
• Last updated: February 21, 2009
• Start date: October 2007
• Est. completion date: February 2008

Study information

• Verified date: February 2009
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytosar
Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle
• Arsenic trioxide
Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hematology-Oncology and SCT Research Center	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response Rate		1, 2, 6 month and one year after intervention	No
Secondary	Overall Survival		One year after intervention	No

External Links

•   Hematology-Oncology and SCT Research Center