Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
Primary Purpose
Leukemia, Myeloid, Acute
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cytosar
Arsenic trioxide
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring AML
Eligibility Criteria
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
Sites / Locations
- Hematology-Oncology and SCT Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Arm one
Arm Description
Outcomes
Primary Outcome Measures
Response Rate
Secondary Outcome Measures
Overall Survival
Full Information
NCT ID
NCT00850304
First Posted
February 21, 2009
Last Updated
February 21, 2009
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT00850304
Brief Title
Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute
Keywords
AML
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm one
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Cytosar
Intervention Description
Cytosar 20 mg /q12h/ sc/10d/q28d for 2 cycle
Intervention Type
Drug
Intervention Name(s)
Arsenic trioxide
Other Intervention Name(s)
ATO
Intervention Description
Arsenic trioxide 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
Primary Outcome Measure Information:
Title
Response Rate
Time Frame
1, 2, 6 month and one year after intervention
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
One year after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamran Alimoghaddam, M.D.
Organizational Affiliation
Hematology-Oncology and SCT Research Center
Official's Role
Study Director
Facility Information:
Facility Name
Hematology-Oncology and SCT Research Center
City
Tehran
ZIP/Postal Code
14114
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Treatment of Non Promyelocytic Acute Myeloid Leukaemia on Elderly Patients by Low Dose Cytosar Plus Arsenic Trioxide
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