Testing New Treatments for Newly Diagnosed, Untreated Patients with High-Risk Acute Myeloid Leukemia (AML)

Program Overview

This study is testing whether new combinations of drugs can more effectively treat high-risk acute myeloid leukemia (AML) compared to the standard treatment of cytarabine and daunorubicin. High-risk AML is harder to treat, and this trial aims to find better ways to shrink the cancer. The experimental treatments include different combinations of drugs like venetoclax, azacitidine, and a special form of daunorubicin and cytarabine. These drugs work by stopping cancer cells from growing or by helping the body produce normal blood cells. Researchers believe these new combinations might be more effective than the current standard treatment.

Description

The main goal of this study is to compare how well different treatment combinations can eliminate cancer cells in patients with high-risk AML. Researchers will look at how many patients achieve complete remission, meaning no signs of cancer, and how long they stay cancer-free. They will also monitor the side effects of each treatment.

Patients will be randomly assigned to one of five treatment groups:

• Group 1: Standard treatment with cytarabine and daunorubicin given through an IV.
• Group 2: Cytarabine and daunorubicin with venetoclax, a drug taken by mouth.
• Group 3: Azacitidine given by injection or IV with venetoclax taken by mouth.
• Group 4: A special form of daunorubicin and cytarabine given through an IV.
• Group 5: The special form of daunorubicin and cytarabine with venetoclax taken by mouth.

Each treatment cycle lasts 28 days, and patients may receive additional cycles if needed. Throughout the trial, patients will have heart scans and bone marrow tests to monitor their health and the treatment's effectiveness. After completing the study treatment, patients will have regular follow-up visits to check their progress.

Eligibility Criteria