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

Contact Investigators or Research Sites near you

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Donald B Wender, MD

June E. Nylen Cancer Center
Sioux City, IA United States
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Recruitment Status: Open

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