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

Document Type : Original Article

Authors

1 Hematologist-Oncologist, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran

2 Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Assistant Professor of Hematology & Oncology, Department of Internal Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

10.22038/psj.2025.86220.1462

Abstract

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.

Keywords

Main Subjects

References

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Journal of Patient Safety & Quality Improvement
Volume 13, Issue 4
October 2025
Pages 201-207

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