Study on Oral Venetoclax and Azacitidine as Maintenance Therapy for Adults with Acute Myeloid Leukemia in First Remission

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04102020

Provider View

This clinical trial is testing the use of oral Venetoclax tablets and Azacitidine as a maintenance treatment for adults with Acute Myeloid Leukemia (AML) who are in their first remission after completing standard chemotherapy.

Patient Parameters

Program Overview

The study is designed to find the best dose of Venetoclax when used with Azacitidine for maintaining remission in patients with Acute Myeloid Leukemia (AML) who have responded to initial chemotherapy. The trial will be conducted in two parts to determine the recommended dose for future studies.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with newly diagnosed Acute Myeloid Leukemia (AML).
  • Must have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after finishing intensive chemotherapy.
  • Achieved first remission within 120 days of starting the study drug or within 75 days of the last dose of intensive chemotherapy.
  • AML must have intermediate or poor risk genetic markers according to specific criteria.
  • Must have a performance status score of 2 or less, indicating they are able to carry out all self-care but unable to carry out any work activities.
  • Must have adequate blood, kidney, and liver function based on lab tests.

Exclusion Criteria

  • History of a specific type of leukemia called acute promyelocytic leukemia (APL).
  • History of active leukemia involvement in the central nervous system.

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