Ignite Creation Date:
2025-12-24 @ 7:56 PM
Ignite Modification Date:
2026-01-01 @ 9:38 AM
Study NCT ID:
NCT00850304
Status:
COMPLETED
Last Update Posted:
2009-02-24
First Post:
2009-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
Sponsor:
Tehran University of Medical Sciences
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: