Last updated on August 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

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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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Jeffrey Schriber, MD

Honor Health Research Institute
Scottsdale, AZ United States
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James Foran, MD

Mayo Clinic Florida
Jacksonville, FL United States
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Mark Litzow, MD

Mayo Clinic Rochester
Rochester, MN United States
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Eunice Wang, MD

Roswell Park Cancer Center Institute
Buffalo, NY United States
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Aziz Nazha, MD

Cleveland Clinic Foundation
Cleveland, OH United States
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Susana Vives, MD

Institut Catala d'Oncologia
Badalona, Spain
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Juan Bergua Burgues, MD

Hospital San Pedro de Alcantara
Cáceres, Spain
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Pau Montesinos, MD

Hospital La Fe
Valencia, Spain
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Priyanka Mehta, MD

Univ Hospital of Bristol
Bristol, United Kingdom
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Richard Dillon, MD

Guys Hospital St. Thomas
London, United Kingdom
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