Study Comparing Azacitidine and Venetoclax with Stem Cell Transplant in People Aged 65 and Older with Acute Myeloid Leukemia

Inclusion Criteria

• Adults aged 65 or older.
• Diagnosed with acute myeloid leukemia (AML) based on specific medical criteria.
• Currently receiving treatment with azacitidine and venetoclax for AML.
• Able to start the first cycle of study treatment 28-42 days after beginning the second cycle of standard azacitidine and venetoclax treatment. If there are delays due to donor issues, an extra cycle of treatment may be given before the transplant.
• Have good organ function to qualify for a stem cell transplant:
  • Heart: No symptoms or symptoms that improve with exercise, with a heart function of more than 40%.
  • Kidneys: Creatinine clearance of 50 ml/min or higher.
  • Lungs: No symptoms or symptoms with lung function over 50% of expected.
  • Liver: Liver function tests less than 5 times the normal limit and bilirubin less than 2 times the normal limit, unless there is a benign condition.
  • Performance status score of 70 or higher.
• Have a suitable donor for the stem cell transplant.
• Achieved a remission with less than 5% cancer cells in the bone marrow, meeting one of the following:
  • Complete remission: Less than 5% cancer cells, with white blood cell count over 1000 and platelets over 100,000.
  • Partial remission: Less than 5% cancer cells, with white blood cell count over 500 and platelets over 50,000.
  • Incomplete remission: Less than 5% cancer cells, with either white blood cell count under 1000 or platelets under 100,000.
• Willing and able to follow the study schedule and requirements.

Exclusion Criteria

• Not eligible for a transplant due to lack of a suitable donor or other health issues.
• Previously had a stem cell transplant.
• Received other leukemia treatments besides azacitidine and venetoclax.
• Had cancer spread to the central nervous system before joining the study.
• Previously treated with venetoclax or similar drugs for a blood cancer.
• Planned to receive treatments other than azacitidine and venetoclax.
• Planned to receive azacitidine and venetoclax with an additional drug.
• Have any other condition that could increase the risk of participating in the study or make participation inappropriate.