A Study of Oral Venetoclax Tablets and Oral Azacitidine as Maintenance Therapy in Adult Participants With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

Sponsor: AbbVie

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04102020

Patient View

This study involves determining the recommended Phase 3 dose of venetoclax with azacitidine for AML maintenance therapy. Eligible participants must have newly diagnosed AML, confirmed remission, and meet specific cytogenetic and health criteria. Interventions include oral venetoclax and azacitidine, administered either orally or via injection.

Patient Parameters

Program Overview

This study will be conducted in two parts. Part 1 will be the Dose Confirmation portion to determine recommended Phase 3 dose (RPTD) of venetoclax in combination with azacitidine (AZA). Part 3 will be the Dose Finding portion to determine RPTD of venetoclax in combination with AZA. Part 2 and Part 3 Randomization of the study were removed.

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of newly diagnosed acute myeloid leukemia (AML).

  • Participant meets the following disease activity criteria:

    • Confirmation of AML by World Health Organization (WHO) criteria (2016) and have confirmed complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following completion of intensive induction and consolidation chemotherapies.
    • Achieved first CR + CRi within 120 days of first dose of study drug or be no more than 75 days since last dose of intensive conventional (including both induction and consolidation) chemotherapies.
    • AML has intermediate or poor risk cytogenetics per National Comprehensive Cancer Network (NCCN) 2016 criteria.

  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2.

  • Participant must have adequate hematologic, renal, and liver function laboratory values as described in the protocol.

Exclusion Criteria

  • History of acute promyelocytic leukemia (APL).
  • History of active central nervous system involvement with acute myeloid leukemia (AML).

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