Phase 3 Study Comparing MAAZA and DAAZA Regimens for Adults 18-75 with Newly Diagnosed Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating a new treatment regimen called MAAZA, which combines mitoxantrone hydrochloride liposomes with cytarabine and azacitidine, for adults newly diagnosed with primary Acute Myeloid Leukemia AML. This study compares the MAAZA regimen with the traditional DAAZA chemotherapy regimen to assess their effectiveness and safety in improving treatment outcomes for AML patients. The trial is a prospective, multicenter, randomized controlled study aiming to provide high-quality clinical evidence to improve AML treatment and prognosis. Participants are randomly assigned to one of two treatment groups. The MAAZA group receives mitoxantrone hydrochloride liposome 24 mgm2 intravenously on day 1 every 4 weeks, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. The comparison group receives daunorubicin 60 mgm2 intravenously once daily for 3 days, cytarabine 100 mgm2 intravenously every 12 hours for 7 days, and azacitidine 100 mg subcutaneously once daily for 7 days. Each treatment cycle lasts 28 days. During the study, participants undergo evaluations including complete remission rates 2 to 3 weeks after the first treatment cycle. Researchers also monitor adverse events, remission rates, survival times, and mortality up to 100 months after randomization. Regular assessments include blood tests and physical health evaluations. The study lasts for multiple cycles and includes long-term follow-up to assess the overall impact of the treatments on patient survival and disease progression.

MA+AZA Regimen for the Treatment of Newly Diagnosed Acute Myeloid Leukemia (AML)