A Phase 1a/b Trial of CG-806 in Patients With Relapsed/Refractory Acute Myeloid Leukemia or Higher-Risk Myelodysplastic Syndromes CG-806

What's the purpose of this trial?

This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or higher-risk MDS, whose disease has relapsed, is refractory or who are ineligible for or intolerant of intensive chemotherapy or transplantation.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Key Inclusion Criteria:

* Age ≥18 years
* Life expectancy of at least 3 months
* ECOG Performance Status ≤ 2
* Patients must be able to swallow capsules
* Adequate hematologic parameters, unless cytopenias are disease caused
* Adequate renal, liver and cardiac functions

Key Exclusion Criteria:

* Patients with GVHD requiring systemic immunosuppressive therapy
* Uncontrolled leptomeningeal disease, auto-immune hemolytic anemia and uncontrolled and clinically significant disease related metabolic disorder
* Clinically significant leukostasis
* Treatment with other investigational drugs or receipt of cytotoxic therapy within 14 days prior to first study treatment administration
* Receipt of cellular immunotherapeutic agents within 4 weeks prior to first study treatment administration

Additional Trial Information

Phase 1

Enrollment: 80 patients (estimated)

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Trial Locations

All Trial Locations

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City of Hope Comprehensive Cancer Center Beckman Research Institute

Duarte, CA

Open and Accepting


Sylvester Comprehensive Cancer Center University of Miami Health System

Miami, FL

Open and Accepting


Robert H. Lurie Comprehensive Cancer Center Northwestern University

Chicago, IL

Open and Accepting


Ochsner Medical Center

Jefferson, LA

Open and Accepting

New Jersey

Atlantic Hem Onc / Morristown Medical Center

Morristown, NJ

Open and Accepting

New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting

Roswell Park Cancer Institute

Buffalo, NY

Open and Accepting



MD Anderson Cancer Center The University of Texas

Houston, TX

Open and Accepting
Interested in this trial?
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