A Phase 2 Study of Azacitidine and Venetoclax in People With Acute Myeloid Leukemia

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Full Title

A Phase 2 Study of Azacitidine and Venetoclax to Treat Acute Myeloid Leukemia Patients with Measurable Residual Disease before an Allogeneic Stem Cell Transplant

Purpose

Some people treated for acute myeloid leukemia (AML) with induction (initial) chemotherapy are left with minimal residual disease (MRD). With MRD, there is a small number of leukemia cells from the bone marrow remaining in the body. MRD increases the chance that the cancer will come back after a bone marrow transplant from a donor.

The drugs azacitidine and venetoclax may work well to get rid of or lower MRD in people with AML. Researchers are doing this study to see if this can be achieved with one treatment cycle of azacitidine and venetoclax. They hope that giving these drugs before a bone marrow transplant will reduce the chance of the leukemia coming back. Azacitidine is given intravenously (by vein) or as an injection, and venetoclax is taken orally (by mouth).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have AML with MRD after induction chemotherapy.
  • Be planning to receive a bone marrow transplant from a donor.
  • Be age 18 or older.
  • You may join this study even if you need help taking care of yourself. You may also join even if you are in a bed or chair for more than half the time you’re awake.

Contact

For more information or to see if you can join this study, please call Dr. Eytan Stein’s office at 646-608-3749.

Protocol

24-347

Phase

Phase II (phase 2)

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06773208