A clinical trial to compare the effectiveness of the granulocyte colony-stimulating factor with standard treatment in non-M3 acute myelogenous leukemia patients

To compare the effectiveness of the granulocyte colony-stimulating factor with standard treatment in non-M3 acute myelogenous leukemia patients.

This randomized and single-blind clinical trial with parallel and control groups will be conducted on 81 patients who will be randomly selected using the blocks.

Non-M3 acute myelogenous leukemia patients referring to Imam Reza Hospital and Ghaem Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the granulocyte colony-stimulating factor and control will receive standard treatment. The person responsible for data collection is blind to group allocation and the type of intervention.

Inclusion criteria: Non-M3 acute myelogenous leukemia patients have not received treatment; aged between 18 and 70 years. Exclusion criteria: Secondary acute myeloid leukemia patients; pregnant women with leukemia; patients with other malignancies; having cardiovascular disease; patients with Anaphylactic shock.

The intervention group will receive 100-200 mg cytarabine for 7 days, 60-90 mg daunorubicin for 3 days and 300 μg granulocyte colony stimulating factor injection on the 8th day. The control group will receive 100-200 mg cytarabine for 7 days and 60-90 mg daunorubicin for 3 days.

Evaluation and comparison of the extinction of disease and one-year survival of patients in control and intervention groups.

In this study, we will use the restricted randomization method of block randomization. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group). Random allocation software software is also used to randomize random sequence production software (Random allocation software). To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the assigned group is not identified before the individual is assigned. Using non-transparent envelopes sealed with random sequences (Sequentially numbered, sealed, opaque envelopes). They are placed in order. In order to maintain the random sequence, numbering is done on the outer surface of the envelopes in the same way. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants in the study, one of the envelopes of the letter will be opened in order and the assigned group of the participant will be revealed.

Non-M3 acute myelogenous leukemia patients referring to Imam Reza Hospital and Ghaem Hospital, Mashhad, Iran are chosen as the participants of the study. In this single-blind study, sealed opaque envelopes will be used to conceal the sequencing. Intervention group will receive the granulocyte colony-stimulating factor and control will receive standard treatment. The person responsible for data collection is blind to group allocation and the type of intervention.

The research data obtained from the main outcomes of the study can be shared freely as 'open data'.

6 months after publishing the results

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

The research data is exclusively accessible to the researchers working at universities and centers for scientific research.

Mostafa Kamandi provides the data analysis to the applicants via email: kamandim@mums.ac.ir

Applicants can send emails to him and receive a response within a week.