Last updated on May 2019

Azacitidine Venetoclax and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia


Brief description of study

This phase I/II trial studies the best dose of venetoclax when given together with azacitidine and pevonedistat and to see how well it works in treating patients with newly diagnosed acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. venetoclax and pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving azacitidine, venetoclax, and pevonedistat may work better in treating patients with acute myeloid leukemia.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To determine the maximum-tolerated dose (MTD) of venetoclax in combination with azacitidine and pevonedistat in patients with previously untreated secondary acute myeloid leukemia (AML). (Phase I) II. To determine the efficacy of the combination regimen, as defined by the rate of complete response (CR) plus complete response with incomplete bone marrow recovery (CRi) within 6 cycles of treatment. (Phase II)

SECONDARY OBJECTIVES:

I. To determine efficacy outcomes, including leukemia response rate (CR + CRi + partial response [PR] + morphologic leukemia free state [MLFS]), minimal residual disease (MRD) negativity by flow cytometry, duration of response, relapse-free survival (RFS), event-free survival (EFS) and overall survival (OS).

II. To determine the safety of the combination regimen.

OUTLINE: This is a phase I, dose-escalation study of venetoclax followed by a phase II study.

Patients receive venetoclax orally (PO) once daily (QD) on days 1-28, azacitidine intravenously (IV) or subcutaneously (SC) on days 1-7, and pevonedistat IV over 60 minutes on days 1, 3, and 5. Treatment repeats every 28 days for up to 24 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 30 days and then every 6 months thereafter.

Clinical Study Identifier: NCT03862157

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M D Anderson Cancer Center

Houston, TX United States
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Recruitment Status: Open


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