Last updated on August 2018

Randomized Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Brief description of study

The purpose of this study is to determine whether CX-01 when given together with standard induction and consolidation therapy for acute myeloid leukemia (AML) will increase the effectiveness of the induction/consolidation therapy. Two different doses of CX-01 will be studied and safety and tolerability will be assessed.

Detailed Study Description

This randomized open-label study is designed to evaluate whether the addition of either or both different dose levels of CX-01 to standard induction therapy and consolidation therapy has a beneficial effect in newly diagnosed AML patients (60 years of age or older) when compared to patients receiving standard induction and consolidation chemotherapy alone. 75 patients will be randomized to one of 3 treatment groups to receive standard induction/consolidation therapy alone or standard induction/consolidation therapy with CX-01 at one of 2 different dose levels (lower and higher). Patients will receive up to 2 induction cycles and up to 2 consolidation cycles and will participate in the study for up to 18 months. Clinical laboratory tests will be conducted routinely, and bone marrow aspirates and biopsies will be performed during the induction cycles. Safety will be monitored through adverse events and clinical laboratory results.

Clinical Study Identifier: NCT02873338

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Matthew Wieduwilt, MD

University of California, San Diego, Moores Cancer Center
La Jolla, CA United States
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Michael Maris, MD

Colorado Blood Cancer Institute
Denver, CO United States
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Stephen E Rubenstein, MD

Franciscan St. Francis Health
Indianapolis, IN United States
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Donald B Wender, MD

June E. Nylen Cancer Center
Sioux City, IA United States
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Don Stevens, MD

Norton Cancer Institute
Louisville, KY United States
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Hana Safah, MD

Tulane University/Tulane Cancer Center
New Orleans, LA United States
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Jay Yang, MD

Karmanos Cancer Institute
Detroit, MI United States
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Michaela Tsai, MD

Allina Health - Virginia Piper Cancer Institute
Minneapolis, MN United States
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Peter Westervelt, MD

Washington University School of Medicine in St. Louis
Saint Louis, MO United States
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Cecilia Arana-Yi, MD

New Mexico Cancer Care Alliance
Albuquerque, NM United States
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Jonathan Kolitz, MD

Northwell Health, Monter Cancer Center
Lake Success, NY United States
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Zartash Gul, MD

University of Cincinnati
Cincinnati, OH United States
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Rachel Cook, MD

Oregon Health & Science University Knight Cancer Institute
Portland, OR United States
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John Reagan, MD

Rhode Island Hospital
Providence, RI United States
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Robert Stuart, MD

Medical University of South Carolina
Charleston, SC United States
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Vinod Parameswaran, MD

Avera Cancer Institute
Sioux Falls, SD United States
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William B Donnellan, MD

Tennessee Oncology/Sarah Cannon Research Institute
Nashville, TN United States
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Moshe Levy, MD

Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center
Dallas, TX United States
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Jose C Cruz, MD

Methodist Healthcare System of San Antonio
San Antonio, TX United States
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Paul Shami, MD

Huntsman Cancer Institute
Salt Lake City, UT United States
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Daanish Hoda, MD

LDS Hospital
Salt Lake City, UT United States
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Stephen Marcus, MD

Swedish Cancer Institute
Seattle, WA United States
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Imaduddin Tabbarah, MD

George Washington University
Washington, WA United States
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Ioannis Mantzaris, MD

Montefiore Medical Center
Bronx, NY United States
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