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IRCT20210703051770N1 IRCT 2022-04-29 Mashhad University of Medical Sciences Evaluation and comparison of treatment regimens in patients with acute leukemia. 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). 2022-03-25 anticipated 36 Complete https://irct.ir/trial/61873 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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-…), Blinding description: 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. 2 Acute T cell leukemia. Intervention 1: Intervention group: In the intervention group, the Hyper CVAD drug regimen is performed in alternating cycles A and B. Cycle A: Cyclophosphamide 300 mg / m2 every 12 hours on days 1, 2, and 3. Vincristine 2 mg / m2 on days 4 and 11. Adriamycin (doxorubicin) 50 mg / m2 on day 4 Dexamethasone 40 mg on days 1, 4, 11, 12, 13 and 14. Methotrexate 12.5 mg with dexamethasone 4 mg intrathecally on day 2. Cycle B: Methotrexate 1 g / m2 on day 1. Cytosar 3 g / m2 every 12 hours on days 2 and 3. Intrathecal methotrexate on day 2. Cyclophosphamide (importer of Sina Pishgam Drug New), Wayne Christine (importer of Valian Drug), Adriamycin (Behestan Drug Company), Vial of methotrexate (Kavosh Daro Gostar Co.), Interferon (Aktor and Sinagen Co.). Intervention 2: Control group: Intravenous arsenic 10 mg daily for 5 days a week. Subcutaneous interferon 5 million units per day. Zidovudine 900 mg daily in 3 doses. Yes - There is a plan to make this available What will be shared: 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. When: Eight to twelve months after the publication of the study results. To whom: The researchers working in scientific centers and academic institutions. Conditions: 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. Where to obtain: Sending a written request to the project manager and all the researchers involved in the project. Mostafa Kamandi: kamandim@mums.ac.ir How to obtain: 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. Comments:
public Mostafa Kamandi
Department of Internal medicine,Emam Reza Hospital, Mashhad.
Mashhad Iran (Islamic Republic of) 9137913316 +98 915 113 5741 kamandim@mums.ac.ir Mashhad University of Medical Sciences scientific Mostafa Kamandi
Department of Internal medicine,Emam Reza Hospital, Mashhad.
Mashhad Iran (Islamic Republic of) 9137913316 +98 915 113 5741 kamandim@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Having acute ATL Being over 18 years of age Having a positive HTLV-I serological test result performed with ELISA 18 years no limit Both Taking drugs that interfere with the treatment regimens used Withdrawing from the study C91.5 Adult T-cell lymphoma/leukemia (HTLV-1-associated) Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group, the Hyper CVAD drug regimen is performed in alternating cycles A and B. Cycle A: Cyclophosphamide 300 mg / m2 every 12 hours on days 1, 2, and 3. Vincristine 2 mg / m2 on days 4 and 11. Adriamycin (doxorubicin) 50 mg / m2 on day 4 Dexamethasone 40 mg on days 1, 4, 11, 12, 13 and 14. Methotrexate 12.5 mg with dexamethasone 4 mg intrathecally on day 2. Cycle B: Methotrexate 1 g / m2 on day 1. Cytosar 3 g / m2 every 12 hours on days 2 and 3. Intrathecal methotrexate on day 2. Cyclophosphamide (importer of Sina Pishgam Drug New), Wayne Christine (importer of Valian Drug), Adriamycin (Behestan Drug Company), Vial of methotrexate (Kavosh Daro Gostar Co.), Interferon (Aktor and Sinagen Co.) Control group: Intravenous arsenic 10 mg daily for 5 days a week. Subcutaneous interferon 5 million units per day. Zidovudine 900 mg daily in 3 doses. Complete Remission. Timepoint: Weekly from before the intervention (beginning of the study) to 60 days after the intervention. Method of measurement: Based on complete response to treatment (Achieving remission or not getting remission) Through chemical tests and CBC. One-year survival. Timepoint: On a daily basis from before the intervention (beginning of the study) to 60 days after the intervention. Method of measurement: Based on the individuals’ survival rate (Calculate the number of days to survive until death) Through the occurrence of death in two groups. Mashhad University of Medical Sciences Approved 2021-11-30 Ethics committee of Mashhad University of Medical Sciences Department of Internal medicine, Emam Reza Hospital, Mashhad. Mashhad Razavi Khorasan Iran (Islamic Republic of)