Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Description

This is a phase 1 study to determine the safety, dosing schedule and recommended phase 2 dose of a triplet therapy with navitoclax, venetoclax, and decitabine for patients with the four high-risk myeloid malignancy subgroups of acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative neoplasm (MDS/MPN) and myelofibrosis accelerated phase (MF-AP).

The U.S. Food and Drug Administration (FDA) has not approved the combination of venetoclax, navitoclax, and decitabine navitoclax as a treatment for any disease.The FDA has approved the combination of venetoclax and decitabine for acute myeloid leukemia (AML) and decitabine given alone is approved for myelodysplastic syndrome (MDS).

The research study procedures include screening for eligibility, study treatments, and blood tests and bone marrow biopsies to assess response to treatment.

Participants will receive the study treatment regimen as long as it is effective.

It is expected that about 36 people will take part in this research study.

AbbVie, a pharmaceutical company, is supporting this research study by providing funding and the study drugs navitoclax and venetoclax.