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

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.