ASTX727, Venetoclax, and Gilteritinib

A Phase I/II Study of ASTX727, Venetoclax, and Gilteritinib for Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome With an Activating FLT3 Mutation

What's the purpose of the trial?

This phase I/II trial studies the best dose of gilteritinib given together with ASTX727 and venetoclax and the effect of ASTX727, venetoclax, and gilteritinib in treating patients with FLT3-mutated acute myeloid leukemia that is newly diagnosed, has come back (relapsed) or does not respond to treatment (refractory) or high-risk myelodysplastic syndrome. Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ASTX727, venetoclax, and gilteritinib may help to control the disease.
Trial status

Accepting patients

Phase
Phase 1/2
Enrollment
42
Last Updated
3 weeks ago
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Participating Centers

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Experimental Treatments

Learn more about the experimental treatments being evaluated in this clinical trial.

  • Gilteritinib is a tyrosine kinase inhibitor that is approved for acute myeloma leukemia patients who are FLT-3 positive. It is currently being studied for use in several different indications.
  • Inqovi is an oral chemotherapy medication. It combines two different drugs, decitabine, which is a hypomethylating chemotherapy agent, and cedazuridine, which is a CDA inhibitor that helps decitabine to work effectively in the body.
  • Venetoclax is a BCL-2 inhibitor that may work by blocking the action of the BCL-2 protein on some cancer cells which can lead to cell death. 

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