A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia

Study Identifier
M14-387
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, Italian

Study Details

Medical Condition
  • Blood Cancer - Acute Myeloid Leukemia (AML)
  • Study Drug
  • Venetoclax
  • Cytarabine
  • Phase
    Phase 1/Phase 2
    Sex
    Female & Male
    Age
    60+ years

    Protocol Summary

    This study consists of two parts: A Phase 1 dose-escalation part that will evaluate the safety and pharmacokinetic profile of venetoclax in combination with low-dose cytarabine (LDAC), define the maximum tolerated dose (MTD), and generate data to support a recommended Phase 2 dose (RPTD) in treatment-naïve participants with acute myelogenous leukemia (AML); and a Phase 2 part that will evaluate if the RPTD has sufficient efficacy and acceptable toxicity to warrant further development of the combination therapy.

    Study Locations

    Location
    Status
    Location
    Univ Kansas Med Ctr /ID# 131175
    Kansas City, Kansas, United States, 66160
    Status
    Not applicable
    Location
    Weill Cornell Medical College /ID# 131170
    New York, New York, United States, 10065
    Status
    Not applicable
    Location
    University of Pittsburgh MC /ID# 131168
    Pittsburgh, Pennsylvania, United States, 15260
    Status
    Not applicable
    Location
    Vanderbilt University Medical Center /ID# 131177
    Nashville, Tennessee, United States, 37232-0011
    Status
    Not applicable
    Location
    Fred Hutchinson Cancer Research Center /ID# 131178
    Seattle, Washington, United States, 98109-1024
    Status
    Not applicable
    Location
    Calvary Mater Newcastle /ID# 136076
    Waratah, New South Wales, Australia, 2298
    Status
    Not applicable
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