Combination Navitoclax, Venetoclax and Decitabine for Advanced Myeloid Neoplasms

Acute Myeloid Leukemia Clinical Trial

Official title: A Phase 1 Study of Triplet Therapy With Navitoclax, Venetoclax, and Decitabine for High-risk Myeloid Malignancies

Status Recruiting

Clinical Trial Summary

The purpose of this research study is to test the safety of a new three drug combination of navitoclax, decitabine, and venetoclax to treat advanced myeloid malignancies.

The names of the drugs involved in this study are:

• Venetoclax

• Decitabine

• Navitoclax

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Myelofibrosis
• Myeloid Malignancy
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Preleukemia
• Primary Myelofibrosis

• NCT number: NCT05455294
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Jacqueline S Garcia, MD
• Phone: 617-632-6349
• Email: Jacqueline_garcia@dfci.harvard.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: July 18, 2022
• Completion date: December 31, 2026