Last updated on February 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) to FLAM compared to AM treatment in refractory or relapsed AML patients with demonstrated NOXA BH3 priming of 40% by mitochondrial profiling in bone marrow.

Detailed Study Description

In Stage 1 of the study, all eligible AML patients with demonstrated NOXA BH3 priming of 40% by mitochondrial profiling in bone marrow will receive treatment with alvocidib, cytarabine and mitoxantrone [ACM ('FLAM') regimen].

In Stage 2, all eligible AML patients with demonstrated NOXA BH3 priming of 40% by mitochondrial profiling in bone marrow will be randomized 1:1 to receive either treatment with ACM or CM (cytarabine and mitoxantrone).

In the NDHR exploratory arm, all eligible patients with newly diagnosed high-risk (NDHR) AML with NOXA BH3 priming 40% by mitochondrial profiling in bone marrow will receive treatment with ACM.

In the NOXA exploratory arm, all eligible AML patients with demonstrated NOXA BH3 priming of 30 - 39% by mitochondrial profiling in bone marrow will receive treatment with ACM.

Clinical Study Identifier: NCT02520011

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Lawrence Morris, MD

Northside Hospital
Atlanta, GA United States
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Carlos Vigil, MD

University of Iowa
Iowa City, IA United States
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Tara Lin, MD

University of Kansas Medical Center
Westwood, KS United States
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Andrew Dalovisio, MD

Ochsner Clinic Foundation
New Orleans, LA United States
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B. Douglas Smith, MD

Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, MD United States
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Mark Frattini, MD

Columbia University Medical Center
New York, NY United States
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Joshua Zeidner, MD

University of North Carolina
Chapel Hill, NC United States
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David Rizzieri, MD

Duke
Durham, NC United States
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Moshe Levy, MD

Baylor Sammons Cancer Center
Dallas, TX United States
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Jorge Cortes, MD

MD Anderson Cancer Center
Houston, TX United States
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Karen Yee, MD

Princess Margaret Cancer Center
Toronto, ON Canada
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Karen Seiter, MD

Hudson Valley Cancer Center
Hawthorne, NY United States
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Darla Liles, MD

East Carolina University
Greenville, NC United States
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Ehab Atallah, MD

Medical College of Wisconsin
Milwaukee, WI United States
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