Last updated on November 2018

Alvocidib Biomarker-driven Phase 2 AML Study


Brief description of study

The purpose of this two-stage Phase 2 study is to assess the clinical response (Complete Remission) of ACM (Alvocidib/Cytarabine/Mitoxantrone) compared to CM (Cytarabine/Mitoxantrone) treatment in refractory or relapsed AML patients with demonstrated MCL-1 dependence of 40% by mitochondrial profiling in bone marrow.

Detailed Study Description

In Stage 1 of the study, all eligible AML patients with demonstrated MCL-1 dependence of 40% by mitochondrial profiling in bone marrow will receive treatment with ACM.

In Stage 2, all eligible AML patients with demonstrated MCL-1 dependence of 40% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM.

In the NDHR exploratory arm, all eligible patients with newly diagnosed high-risk (NDHR) AML with MCL-1 dependence of 40% by mitochondrial profiling in bone marrow will receive treatment with ACM.

In the MCL-1 dependency exploratory arms, all eligible AML patients with demonstrated MCL-1 dependence of 30 - <40% (Arm A), 15% - <30% (Arm B), or 0 - <15% (Arm C) by mitochondrial profiling in bone marrow who are either in first relapse (within 24 months of CR) or have primary refractory AML (ie, no CR or CRi after 2 cycles of intensive anthracycline/cytarabine etoposide or cladribine induction) will receive treatment with ACM.

Clinical Study Identifier: NCT02520011

Contact Investigators or Research Sites near you

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Northside Hospital

Atlanta, GA United States
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University of Iowa

Iowa City, IA United States
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Ochsner Clinic Foundation

New Orleans, LA United States
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University of North Carolina

Chapel Hill, NC United States
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Duke

Durham, NC United States
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MD Anderson Cancer Center

Houston, TX United States
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Hudson Valley Cancer Center

Hawthorne, NY United States
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East Carolina University

Greenville, NC United States
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Medical College of Wisconsin

Milwaukee, WI United States
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Honor Health Research Institute

Scottsdale, AZ United States
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Mayo Clinic Florida

Jacksonville, FL United States
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Mayo Clinic Rochester

Rochester, MN United States
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Cleveland Clinic Foundation

Cleveland, OH United States
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Univ Hospital of Bristol

Bristol, United Kingdom
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Recruitment Status: Open


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