Determining the clinical effect of deferoxamine on the treatment of AML
Design
a clinical trial with a control group with parallel, double-blind, randomized control groups, phase 3, on 40 patients, a random number table is used for randomization.
Settings and conduct
This trial will be performed in the blood and oncology department of Shahid Bahonar Hospital in Kerman. Patients whose type of disease and prognosis will be determined and also meet the conditions for inclusion in the study will be randomly admitted to one of the two intervention groups. The doctor and the patients will be blind and patients will receive the desired intervention for 14 days. And then the primary and secondary variables will be evaluated on days 14 and 28 of the study
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age between 18 -65 years; both gender; patients with AML/non-APL.
Exclusion criteria: HIV infected patients or Hepatitis B, C patients; patients with AML-induced neurological involvement; patients with uncontrolled blood pressure and heart failure; patients with a history of ocular toxicity due to iron chelators.
Intervention groups
Control group: standard treatment. Intervention group: standard treatment with deferoxamine.
Main outcome variables
The rate of apoptotic cells of CD34 + leukemia blasts; the rate of Reactive oxygen species in CD34+ leukemia blast: the percentage of leukemia blasts in AML patients after receiving treatment.
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20200313046756N2
Registration date:2021-05-08, 1400/02/18
Registration timing:prospective
Last update:2021-05-08, 1400/02/18
Update count:1
Registration date
2021-05-08, 1400/02/18
Registrant information
Name
Vahid Maazed
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 1223 5019
Email address
maazed@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-10, 1400/03/20
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferoxamine in Shahid Bahonar Hospital of Kerman
Public title
Evaluation the Effect of deferoxamine on the treatment of ََAcute myeloid leukemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 years
AML/non-APL
Exclusion criteria:
HIV infected patients or Hepatitis B,C patients
Patients with AML-induced neurological involvement
Patients with uncontrolled blood pressure and heart failure
Patients with a history of ocular toxicity due to iron chelators drugs
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups n = 20 (including dropout) by the statistical specialist of the project. According to the table of random numbers, the researcher considers even numbers for intervention group 1 and odd numbers for intervention group 2, then puts his hand on one of the numbers and moves upwards and records the numbers, and assigns the patients based on reference to different groups
Blinding (investigator's opinion)
Double blinded
Blinding description
People will be kept blind.
1. Patients: Each patient will receive a label according to the random number table that will appear on the patient's drug package.
2. Physician: The analyzing team will give the medicine boxes to the physician, and the physician will provide the medication based on the random number table.
Placebo
Not used
Assignment
Parallel
Other design features
one group receiving standard treatment(without placebo) and the other group receive the standard treatment and interventional drug
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Kerman University of Medical Sciences
Street address
Beginning of Ibn Sina Street, First of Jihad Boulevard, Somayeh intersection (Tahmasb Abad)
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-11-23, 1399/09/03
Ethics committee reference number
IR.KMU.REC.1399.482
Health conditions studied
1
Description of health condition studied
Acute myeloblastic leukemia
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
The number of white blood cells
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count
2
Description
Number of red blood cells
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count
3
Description
platelet numbers
Timepoint
on days 14 and 28
Method of measurement
Test for complete blood cell count
4
Description
Percentage of CD34 + leukemia blasts of bone marrow biopsy specimen
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry with CD34 monoclonal antibody
Secondary outcomes
1
Description
Reactive oxygen species rate in +CD34 leukemic blasts bone marrow biopsy sample
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry
2
Description
The rate of apoptotic cells in +CD34 leukemic blasts bone marrow biopsy sample
Timepoint
on days 14 and 28
Method of measurement
Flow cytometry
Intervention groups
1
Description
Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with IV infusion of Deferoxamine 1000 mg for 8 to 12 hours daily at the first 14 days
Category
Treatment - Drugs
2
Description
Control group: receive the standard treatment Cytarabine and idarubicin (7+3) without Placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Bahonar Hospital of Kerman
Full name of responsible person
َAliasghar Tirgar
Street address
Kerman Province, Kerman, Qaraney St
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3223 5011
Fax
+98 34 3226 0100
Email
maazed@kmu.ac.ir
Web page address
http://bh.kmu.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Kerman university of medical sciences,Medical University Campus,Haft-Bagh Highway,Kerman,Iran
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5856
Email
abpardakhty@kmu.ac.ir
Web page address
http://kmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Nano Fanavaran Alvand pharmaceutical co.
Full name of responsible person
Babak Yazdani
Street address
No. 485, Unit 52 Between 63 St & 65 St Yousef Abad St. Tehran, IRAN
City
Tehran
Province
Tehran
Postal code
1439955991
Phone
+98 21 8802 0579
Fax
+98 21 8802 0579
Email
info@nanoalvand.com
Web page address
http://www.nanoalvand.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nano Fanavaran Alvand pharmaceutical co.
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
3
Sponsor
Name of organization / entity
AryaTinaGene biopharmaceutical co.
Full name of responsible person
Behnam Taghavi
Street address
Second Sazandegi, Aq qalla Industrial state, Gorgon, Iran
City
Gorgan
Province
Golestan
Postal code
4931171756
Phone
+98 17 3453 3545
Fax
+98 17 3453 3545
Email
info@atgbio.com
Web page address
http://www.atgbio.com/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Associated Professor in Kerman University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
3 number Alley, Najafi Lary st., Jomhoori Islami Blvd, Kerman, Iran
City
Kerman
Province
Kerman
Postal code
7619655598
Phone
+98 34 3244 2425
Email
Moazed_vahid@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Aliasghar Tirgar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
no.14, Alley 1, Shahidan ghotbi nezhad Ave,Azadegan Blvd,Kerman Town
City
Kerman
Province
Kerman
Postal code
7619677886
Phone
+98 34 3246 2413
Email
tirgar4@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be initially de-identified. 1. Demographic Data of Participants: These data will generally be included in a table in the article. 2. Main outcome data: The article will be appended to the article in charts and tables as well as in an Excel file. Secondary outcome data in the article will be attached to the article in graphs and tables as well as in an Excel file.
When the data will become available and for how long
Starting data access period six months after the results are published
To whom data/document is available
Data will be available only to researchers working in academic and scientific institutions approved by the Ministry of Health
Under which criteria data/document could be used
The data will be available to researchers for further statistical analysis
From where data/document is obtainable
Refer to the person responsible for the project's scientific accountability to access the data
What processes are involved for a request to access data/document
Applicants will submit a personal resume and the purpose of the data to the person responsible for the scientific account of the plan. The responsible person will be required to investigate the request within one week of sending the researcher information