Feasibility study of treatment of non promyelocytic acute myeloid leukemia in elderly patients by low dose cytozar plus Arsenic trioxide on ambulatory schedule
Our purpose in this study is to explore the feasibility of treatment of non promyelocytic acute myeloid leukemia in elderly patients. We select ten patients with age further than 60 and treat by low dose cytozar subcutaneously plus arsenic trioxide for ten days in month. We will assess overall response rate and overall survival at the end of one year.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138711061030N5
Registration date:2009-02-16, 1387/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-02-16, 1387/11/28
Registrant information
Name
Mahdi Jalili
Name of organization / entity
Hematology-Oncology & SCT Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2662
Email address
m_jalili@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2007-10-23, 1386/08/01
Expected recruitment end date
2008-02-20, 1386/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Feasibility study of treatment of non promyelocytic acute myeloid leukemia in elderly patients by low dose cytozar plus Arsenic trioxide on ambulatory schedule
Public title
Treatment of non promyelocytic acute myeloid leukemia in elderly patients by low dose cytozar plus Arsenic trioxide
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Elderly patients with non promyelocytic AML, Performance status (ECOG) 3 or 4
Exclusion criteria:
Age <60 years old, AST or ALT more than ten times above normal, Serum billirubin above 5, Creatinine level>2
Age
From 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hematology-Oncology and SCT Research Center
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Approval date
2008-03-18, 1386/12/28
Ethics committee reference number
418/ A / 7199
Health conditions studied
1
Description of health condition studied
Acute myeloid leukaemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloid leukaemia
Primary outcomes
1
Description
Response Rate
Timepoint
1, 2, 6 month and one year after intervention
Method of measurement
Bone Marrow Aspiration and Biopsy and complete blood count
Secondary outcomes
1
Description
Overal Survival
Timepoint
One year after intervention
Method of measurement
Survey of patients
Intervention groups
1
Description
Cytozar 20 mg /q12h/ sc/10d/q28d for 2 cycle
Category
empty
2
Description
Arsenic 10mg/infusion2h/iv/DW5% d1-d5,d7-d11
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology and SCT Research Center
Full name of responsible person
Dr. Seyed Mehdi Hashemi
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Yonesian
Street address
Tehran University of Medical Sciences
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Dr. Seyed Mehdi Hashemi
Position
Principal Investigator / Fellowship
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
horcbmt@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology-Oncology and SCT Research Center
Full name of responsible person
Dr. Seyed Mehdi Hashemi
Position
Principal Investigator / Fellowship
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2635
Fax
+98 21 8800 4140
Email
horcbmt@sina.tums.ac.ir
Web page address
http://horcsct.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Dr. Mahdi Jalili
Position
Clinical Trials Unit secretary / MD
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
14114
Phone
+98 21 8490 2668
Fax
+98 21 8800 4041
Email
horcsct@yahoo.com
Web page address
http://horcsct.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)