Phase II Study Comparing Standard Cytarabine and Daunorubicin Treatment to New Drug Combinations for High-Risk Acute Myeloid Leukemia in Adults Aged 18 to 59

What this Trial Is About

Researchers are evaluating different treatment approaches for patients newly diagnosed with high-risk acute myeloid leukemia AML who have not yet started treatment. This phase II trial compares the standard chemotherapy combination of cytarabine and daunorubicin to four experimental regimens that include daunorubicin and cytarabine liposome, venetoclax, and azacitidine. The goal is to see which regimen is better at reducing measurable residual disease and inducing remission in this difficult-to-treat form of AML. Participants are randomly assigned to one of five treatment groups. Each group receives a different combination of drugs standard cytarabine and daunorubicin, cytarabine and daunorubicin with venetoclax, azacitidine with venetoclax, daunorubicin and cytarabine liposome alone, or daunorubicin and cytarabine liposome with venetoclax. Treatments are given in cycles lasting 28 days, with specific dosing schedules for each drug. Some patients may receive an additional cycle depending on their response and tolerance. Before starting treatment, participants undergo echocardiography or MUGA scans to assess heart function. During the trial, participants have bone marrow aspirations and blood collections to monitor their disease and treatment effects. After completing the study treatment, participants have regular follow-up visits monthly during the first year, every two months in the second year, every three months in the third year, and then every six months until five years after treatment. Researchers measure remission rates, survival outcomes, and side effects to evaluate each treatments impact and safety over time.

Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)