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Kamandi, Mostafa, Moghaddamnia, Fereshteh, Ataei Azimi, Sajjad. (1404). Efficacy of Hyper-CVAD Drug Regimen in Adult T-Cell Leukemia (ATL) Patients: A Randomized Clinical Trial. , 13(4), 201-207. doi: 10.22038/psj.2025.86220.1462
Mostafa Kamandi; Fereshteh Moghaddamnia; Sajjad Ataei Azimi. "Efficacy of Hyper-CVAD Drug Regimen in Adult T-Cell Leukemia (ATL) Patients: A Randomized Clinical Trial". , 13, 4, 1404, 201-207. doi: 10.22038/psj.2025.86220.1462
Kamandi, Mostafa, Moghaddamnia, Fereshteh, Ataei Azimi, Sajjad. (1404). 'Efficacy of Hyper-CVAD Drug Regimen in Adult T-Cell Leukemia (ATL) Patients: A Randomized Clinical Trial', , 13(4), pp. 201-207. doi: 10.22038/psj.2025.86220.1462
Kamandi, Mostafa, Moghaddamnia, Fereshteh, Ataei Azimi, Sajjad. Efficacy of Hyper-CVAD Drug Regimen in Adult T-Cell Leukemia (ATL) Patients: A Randomized Clinical Trial. , 1404; 13(4): 201-207. doi: 10.22038/psj.2025.86220.1462

Efficacy of Hyper-CVAD Drug Regimen in Adult T-Cell Leukemia (ATL) Patients: A Randomized Clinical Trial

Journal of Patient Safety & Quality Improvement
دوره 13، شماره 4، دی 2025، صفحه 201-207    اصل مقاله (347.95 K)
نوع مقاله: Original Article
شناسه دیجیتال (DOI): 10.22038/psj.2025.86220.1462
نویسندگان
Mostafa Kamandi* 1؛ Fereshteh Moghaddamnia2؛ Sajjad Ataei Azimi3
1Hematologist-Oncologist, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
2Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
3Assistant Professor of Hematology & Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
چکیده
Introduction:
Adult T-cell leukemia (ATL), a hematologic malignancy caused by Human T-lymphotropic virus type 1 (HTLV-I) infection, is known for its aggressive course, limited treatment responsiveness, and short survival. This clinical trial compared the therapeutic effects of two treatment approaches-Hyper-CVAD and the combination of arsenic trioxide, interferon-alpha, and zidovudine (As/IFN/AZT)-in newly diagnosed acute ATL patients.
 
Materials and Methods:
In this randomized study, patients with confirmed HTLV-I infection by ELISA and/or PCR were assigned using block randomization to receive either Hyper-CVAD or As /IFN/AZT over a 60-day treatment period. A total of 29 patients completed the protocol, and therapeutic responses were assessed following completion of therapy.
 
Results:
Baseline characteristics, including gender distribution, serum lactate dehydrogenase (LDH) levels, and lymphocyte counts, showed no significant differences between the groups (P > 0.05). Response rates were 46.67% in the Hyper-CVAD group and 35.71% in the As/IFN/AZT group, without statistical significance (P > 0.05). However, survival analysis indicated better outcomes with Hyper-CVAD (P < 0.05). Hematologic toxicity was the most common adverse event, with Grade 3 events observed in one patient receiving Hyper-CVAD and three patients receiving As/IFN/AZT.
 Conclusion:
While both regimens demonstrated comparable efficacy in overall response, the As/IFN/AZT protocol was associated with higher toxicity. Larger-scale investigations are needed to determine its optimal role and timing as a first-line option for ATL.
کلیدواژه‌ها
Keywords: Acute promyelocytic leukemia؛ extramedullary manifestation؛ myeloid sarcoma؛ PML/RARa translocation
مراجع
                Cingam SR, Koshy NV. Cancer, acute promyelocytic leukemia. StatPearls. Treasure Island (FL): StatPearls Publishing; 2020.

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