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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00850304

Enrollment

Registered

2009-02-24

Start date

2007-10-31

Completion date

2008-02-29

Last updated

2009-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Acute

Keywords

AML

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.

Interventions

DRUGCytosar

Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle

DRUGArsenic trioxide

Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Response Rate	1, 2, 6 month and one year after intervention

Secondary

Measure	Time frame
Overall Survival	One year after intervention

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026