a pilot study to Assess the therapeutics indicators in Patients With Acute Myeloid Leukemia Undergoing therapy With deferasirox in Afzalipour Hospital of Kerman

Determining the clinical effect of deferasirox on the treatment of AML

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.

This trial will be performed in the blood and oncology department of Afzalipour 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 outcome assessor and the patients will be blind and patients will receive the desired intervention for 28 days. And then the primary and secondary variables will be evaluated on days 14 and 28 of the study

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.

Control group: standard treatment. Intervention group: standard treatment with deferasirox.

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.

- Change of study site: due to relocation of the hematology and oncology ward from Shahid Bahonar Hospital in Kerman to Afzalipour Hospital -change the form of the intervention drug: based on the necessity of the prophylactic antifungal drugs administration to prevent side effects of the interventional drug and the difficulty of obtaining these drugs due to the coronavirus pandemic caused conditions, to reduce the potential hazards of intervention, the intravenous form of the drug (deferoxamine) is replaced by the oral form of that (deferasirox). The request for this change has been approved by the University Ethics Committee, recently. -time of starting the Patient recruitment: minimizing the potential risks of intervention for patients because of the weakened immune condition caused by the course of treatment in the coronavirus pandemic duration, a long-term process of negotiation with study sponsors to fund it due to provide the necessary laboratory materials and equipment to evaluate the outcomes of the study has not been possible up to now And it is estimated that would be possible in the next few months. -Randomization: Due to the importance of patients' prognosis and its effect on the expected therapeutic response rate, the method of randomization was changed from simple to permuted block randomization. -Blinding: To optimize the level of concealment, we changed the blindness from physician to data analyst

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

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.

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.

Starting data access period six months after the results are published

Data will be available only to researchers working in academic and scientific institutions approved by the Ministry of Health

The data will be available to researchers for further statistical analysis

Refer to the person responsible for the project's scientific accountability to access the data

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