Evaluation and comparison of the effectiveness of Hyper CVAD and Arsenic/ interferon/ zidovudine (As/IFN/AZT) treatment regimens in patients with acute Adult T-cell leukemia (ATL).

This study aimed to evaluate and compare the effectiveness of Hyper-CVAD and Arsenic/ interferon/ zidovudine (As / IFN / AZT) regimens In the treatment of acute adult T-cell leukemia (ATL ).

The controlled clinical trial with parallel groups was carried out as a double-blind, randomized study, phase 2 of which was conducted on 36 patients. The randomization based on sealed envelopes was performed using the Randomaize.com website.

ATL patients referred to Mashhad University of Medical Sciences will be randomly divided into intervention and control groups and The As / IFN / AZT and Hyper CVAD drug regimens would be prescribed for 60 days, and in case of drug poisoning, not only the doses would be reduced but also the time period would be reduced by half if the individuals were intolerant. Prior to the research, all participants would undergo routine tests including CBC, biochemistry, viral serology, and chest, abdomen, and pelvic CTs. A stool test would also be performed to check for strongyloidesstercoralis infection. CBC and biochemical tests would be repeated once a week. In this study, participants are blinded to the intervention received based on codes (codes A and B).

The inclusion criteria were acute ATL, over18 years of age, a positive human T-cell lymphotropic virus type 1 (HTLV-I) serological test performed with enzyme-linked immunosorbent assay (ELISA) or Polymerase chain reaction (PCR). The exclusion criteria were the existence of underlying diseases, the use of drugs that interfered with the treatment regimens.

The Hyper CVAD drug regimen was prescribed to the intervention group. The control group would receive the As / IFN / AZT regimen.

Complete remission, the overall survival rate

Block randomization: This type of randomization will be done using the site https://www.sealedenvelope.com. In this method, the volume of each block must first be determined. Then, a list of the blocks are prepared and numbers are assigned to each (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)). In the next step, random numbers from 1 to 6 are selected (e.g. 1 4 5, etc.) and finally, the treatment allocation list is specified based on the previous random numbers (AABB-BBAA-BABA-…).

In this study, participants are blinded to the intervention received based on codes (codes A and B) that people are unaware of the type of intervention received and only researchers are aware of it. Also, the drugs are the same in shape, color and coating to allow blindness at the participant level.

Because the researchers follow ethical standards, the information of all the participants will be recorded anonymously, and their informed consent on the publication of the research results will be got to avoid any problems regarding the publication of the study data.

Eight to twelve months after the publication of the study results.

The researchers working in scientific centers and academic institutions.

1- Contributing to continue clinical research in this field 2- Using in systematic reviews 3- Performing more statistical analyzes to improve the reporting accuracy and reduce possible errors.

Sending a written request to the project manager and all the researchers involved in the project. Mostafa Kamandi: kamandim@mums.ac.ir

Corresponding with the clinical trial director; 2- Consultation of the clinical trial director with other researchers involved in the project; 3- Obtaining permission from other members; 4- Corresponding with the faculty to provide the data; 5- In case of a positive answer, corresponding and sending the data in accordance with the request.