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IRCT20200313046756N2 IRCT 2021-05-08 Kerman University of Medical Sciences Evaluation of the Effect of deferasirox on the treatment of ََAcute myeloid leukemia ندارد a pilot study to Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferasirox in Afzalipour Hospital of Kerman 2022-09-23 anticipated 40 Complete https://irct.ir/trial/51397 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: one group receiving standard treatment(without placebo) and the other group receive the standard treatment and interventional drug, Randomization description: Patients divide into two groups n = 20 (including dropouts). Block permuted randomization method uses, based on that, patients organize in a three-level prognosis(A, B, C) in each three-person block of any interventional group. According to the random numbers chart, the researchers consider even numbers for the control group and odd numbers for the intervention group, then put their hand on one of the numbers and move upwards and record the numbers, and assign the patients based on that individual group, Blinding description: People will be kept blind. Patient: Receives the intervention drug in combination with the daily meals outcome assessor: The information of each patient is provided to the analyzer team in an unidentifiable manner with unique codes. They are also not aware of the details of the study process. 3 Acute myeloblastic leukemia. Intervention 1: Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with oral intake of Deferasirox capsule 360 mg daily for 28 days. Intervention 2: Control group: receive the standard treatment Cytarabine and idarubicin (7+3) without Placebo. Yes - There is a plan to make this available What will be shared: 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: Starting data access period six months after the results are published To whom: Data will be available only to researchers working in academic and scientific institutions approved by the Ministry of Health Conditions: The data will be available to researchers for further statistical analysis Where to obtain: Refer to the person responsible for the project's scientific accountability to access the data How to obtain: 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 Comments:
public Aliasghar Tirgar
no.14 , Alley 1 , shahidan ghotbi nezhad Ave, Azadegan Blvd, Kerman Town
Kerman Iran (Islamic Republic of) 7619677886 0098342462413 a.tirgar@kmu.ac.ir Kerman University of Medical Sciences scientific Vahid Moazed
3 number Alley, Najafi Lary st., Jomhoori Islami Blvd, Kerman, Iran
Kerman Iran (Islamic Republic of) 7619655598 +98 34 3244 2425 Moazed_vahid@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Age between 18-65 years AML/non-APL 18 years 65 years Both 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 C92.0 Acute myeloblastic leukemia Treatment - Drugs Treatment - Drugs Intervention group: receive the standard treatment Cytarabine and idarubicin (7+3) with oral intake of Deferasirox capsule 360 mg daily for 28 days Control group: receive the standard treatment Cytarabine and idarubicin (7+3) without Placebo The number of white blood cells. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count. Number of red blood cells. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count. Platelet numbers. Timepoint: on days 14 and 28. Method of measurement: Test for complete blood cell count. 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. Reactive oxygen species rate in +CD34 leukemic blasts bone marrow biopsy sample. Timepoint: on days 14 and 28. Method of measurement: Flow cytometry. The rate of apoptotic cells in +CD34 leukemic blasts bone marrow biopsy sample. Timepoint: on days 14 and 28. Method of measurement: Flow cytometry. Nano Fanavaran Alvand pharmaceutical co. AryaTinaGene biopharmaceutical co. Kerman University of Medical Sciences Nano Fanavaran Alvand pharmaceutical co. AryaTinaGene biopharmaceutical co. Approved 2020-11-23 Research Ethics Committee of Kerman University of Medical Sciences Beginning of Ibn Sina Street, First of Jihad Boulevard, Somayeh intersection (Tahmasb Abad) Kerman Kerman Iran (Islamic Republic of)