Trial Details

Multicenter, Phase 3 Study of Venetoclax and Azacitidine as Maintenance Therapy for Patients With Acute Myeloid Leukemia in First Remission After Conventional Chemotherapy

NCT04102020

ACTIVE_NOT_RECRUITING

DESCRIPTION

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.

CONDITIONS

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).