A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy

What this Trial Is About

Researchers are evaluating two induction chemotherapy treatments, VA (Venetoclax plus Azacitidine) and D/IA (Daunorubicin or Idarubicin plus Cytarabine), in elderly patients aged 55 to 75 years with acute myeloid leukemia (AML) who are fit for intensive chemotherapy. This phase III, multicenter, randomized trial aims to compare the effectiveness of these regimens in this patient group. The study is sponsored by the Institute of Hematology & Blood Diseases Hospital in China. Participants receive induction therapy with either the D/IA regimen including Cytarabine and Daunorubicin or Idarubicin, or the VA regimen involving Azacitidine and Venetoclax. Induction cycles may be repeated if remission is not achieved. Consolidation therapy with intermediate-dose Cytarabine is given in both groups. Maintenance therapy varies based on risk level, with low/intermediate-risk patients receiving either DA/IA or VA regimens, and high-risk patients receiving extended VA treatment. Allogeneic transplantation is recommended for high-risk patients or those with persistent minimal residual disease. During the study, participants undergo evaluations including survival monitoring for up to one year after enrollment completion. Researchers measure overall survival as the primary outcome and assess remission rates, minimal residual disease negativity, relapse-free and event-free survival, and early mortality rates as secondary outcomes. Patients are followed closely with clinical assessments and laboratory tests throughout the treatment and observation periods.

Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients