A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia

Study Identifier
M16-802
CT.gov Identifier
NCT03625505
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
    • Study Drug
  • Venetoclax
  • Gilteritinib
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Should have an established, confirmed diagnosis of Acute Myeloid Leukemia (AML) by World Health Organization (2016). * Should have failed at least 1 line of prior therapy (defined as failure to respond to therapy, and/or progression during or after therapy). * Should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. * Should have adequate hematologic, kidney and liver function as described in the protocol. * For participants enrolling into the Expansion Cohort only: a documented FMS-like Tyrosine Kinase (FLT3) mutation in bone marrow or peripheral blood, as described in the protocol.
    Exclusion Criteria:
    * Has a diagnosis of acute promyelocytic leukemia (APL) or BCR-ABL-positive leukemia. * Has a history of other malignancies within 2 years prior to study entry, with exceptions as described in the protocol. * Has active central nervous system leukemia. * Has a history of chronic New York Heart Association (NYHA) class IV heart failure. * Has a corrected QT interval of \> 450 ms. * Has a chronic respiratory disease that requires continuous oxygen use.

    Protocol Summary

    A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who have failed to respond to, and/or have relapsed or progressed after at least 1 prior therapy.

    Study Locations

    Location
    Status
    Location
    David Geffen School of Medicin /ID# 200166
    Los Angeles, California, United States, 90095
    Status
    Not applicable
    Location
    UC San Francisco Medical Center-Parnassus /ID# 200205
    San Francisco, California, United States, 94143-2202
    Status
    Not applicable
    Location
    Sylvester Comprehensive Cancer /ID# 200268
    Miami, Florida, United States, 33136-1002
    Status
    Not applicable
    Location
    Northwestern Memorial Hospital /ID# 200230
    Chicago, Illinois, United States, 60611-2927
    Status
    Not applicable
    Location
    Norton Cancer Institute /ID# 200623
    Louisville, Kentucky, United States, 40202-3700
    Status
    Not applicable
    Location
    Johns Hopkins University /ID# 200349
    Baltimore, Maryland, United States, 21287
    Status
    Not applicable
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