The determination and comparison of plasma concentration of arsenic trioxide as intravascular and oral agent used in patients with Acute promyelocytic leukemia
Purpose of this study is trying oral formulation (as capsule) of Arsenic instead of intravascular. Totally 10 patients with Acute promyelocytic leukemia type M3 and in complete remission treat with oral and intravascular arsenic trioxide. We determine plasma concentration of arsenic trioxide and calculate the Area Under the Curve(AUC) of Arsenic in both form of administration and compare them.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710271030N4
Registration date:2009-03-09, 1387/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-03-09, 1387/12/19
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
Hematology-Oncology and SCT Research Center
Expected recruitment start date
2009-01-20, 1387/11/01
Expected recruitment end date
2009-04-20, 1388/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The determination and comparison of plasma concentration of arsenic trioxide as intravascular and oral agent used in patients with Acute promyelocytic leukemia
Public title
Arsenic trioxide as intravascular or oral agent used in patients with Acute promyelocytic leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Acute promyelocytic leukemia type M3, complete remission, not receiving any marine foods during last week, normal cardiopulmonary and renal function.
Exclusion Criteria: Less than 16 years old, Impaired cardiopulmonary and renal function.
Age
From 16 years old
Gender
Both
Phase
1-2
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
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hematology-Oncology and SCT Research Center Ethics committee
Street address
Shariati Hospital, Kargar Ave.
City
Tehran
Postal code
14114
Approval date
2008-08-12, 1387/05/22
Ethics committee reference number
ك د/87/625
Health conditions studied
1
Description of health condition studied
Acute promyelocytic leukemia
ICD-10 code
C92.4
ICD-10 code description
Acute promyelocytic leukemia
Primary outcomes
1
Description
plasma concentration of arsenic trioxide
Timepoint
0,1,2,3,4,6,8,24,25,26,27,28,30,32,48h after initiation of therapy
Method of measurement
Atomic Absorption of Arsenic
Secondary outcomes
1
Description
side effects
Timepoint
During the study
Method of measurement
History taking and physical examination
Intervention groups
1
Description
At first day: Arsenic trioxide, 10 mg, capsule
Category
Treatment - Drugs
2
Description
At second day: Arsenic trioxide, 10 mg, infusion
Category
empty
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology-Oncology and SCT Research Center
Full name of responsible person
Aliarash Anoshiravani
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology-Oncology & SCT Research Center
Full name of responsible person
Mojtaba Ramezani
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology-Oncology & SCT Research Center
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
Aliarash Anoushiravani
Position
Principal Investigator / Fellowship
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
anoush_aa@yahoo.com
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
Aliarash Anoushiravani
Position
Principal Investigator / Fellowship
Other areas of specialty/work
Street address
Kargar Ave. Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2635
Fax
Email
anoush_aa@yahoo.com
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
Email
horcsct@yahoo.com
Web page address
http://horcsct.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)