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

Study Identifier
M19-708
CT.gov Identifier
NCT04102020
EudraCT Identifier
Not available
EUCTIS ID
2023-507221-42-00
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
  • Venetoclax
  • Azacitidine
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion 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).

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Mitchell Cancer Institute /ID# 216443
    Mobile, Alabama, United States, 36604
    Status
    Not applicable
    Location
    Compassionate Cancer Care Research Group - Fountain Valley /ID# 216156
    Fountain Valley, California, United States, 92708-7501
    Status
    Not applicable
    Location
    University of California, Los Angeles /ID# 219149
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    Colorado Blood Cancer Institute /ID# 214280
    Denver, Colorado, United States, 80218
    Status
    Not applicable
    Location
    St. Alphonsus Regional Medical /ID# 216424
    Boise, Idaho, United States, 83706
    Status
    Not applicable
    Location
    Duplicate_Rush University Medical Center /ID# 218815
    Chicago, Illinois, United States, 60612
    Status
    Not applicable
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