A Study of Venetoclax and Alvocidib in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Study Identifier
M16-186
CT.gov Identifier
NCT03441555
EudraCT Identifier
2017-002531-42
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
  • Alvocidib
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Must have adequate coagulation, hematology, kidney, and liver function, per protocol. * Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML) * Meet the following disease activity criteria: * an established, confirmed diagnosis of AML by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3; and * an Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * If male participant is sexually active, he must agree from day 1 through 6 months after the last dose of alvocidib or 90 days after the last dose of venetoclax, whichever is longer, to practice the protocol-specified protection.
    Exclusion Criteria:
    * History of any malignancy within the last 6 months except for those specified in this protocol and low-grade malignancies not requiring active treatment such as non-melanoma skin cancer, cervical intraepithelial neoplasia, or prostate cancer in situ. * Prior allogeneic stem cell transplant within 6 months of study drug administration and no requirement for graft versus host therapy. * History of previous enrollment in Studies NCT02993523 or NCT03069352. * History of exposure to alvocidib or any other cyclin-dependent kinase 9 (CDK9) inhibitor. * History of Tumor Lysis Syndrome (TLS) due to previous exposure to venetoclax.

    Protocol Summary

    An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).

    Study Locations

    Location
    Status
    Location
    USC Norris Cancer Center /ID# 170844
    Los Angeles, California, United States, 90033
    Status
    Not applicable
    Location
    UC Irvine /ID# 201093
    Orange, California, United States, 92868
    Status
    Not applicable
    Location
    University of California, Davis Comprehensive Cancer Center /ID# 170799
    Sacramento, California, United States, 95817
    Status
    Not applicable
    Location
    Sylvester Comprehensive Cancer /ID# 170761
    Miami, Florida, United States, 33136-1002
    Status
    Not applicable
    Location
    Indiana Blood & Marrow Transpl /ID# 170793
    Indianapolis, Indiana, United States, 46237
    Status
    Not applicable
    Location
    NYU Langone Medical Center /ID# 201559
    New York, New York, United States, 10016-6402
    Status
    Not applicable
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