SHS_492341 MAWR CCNT 16105

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

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. Three different doses of CX-01 will be studied and safety and tolerability will be assessed. This randomized open-label study is designed to evaluate whether the addition of either or all 3 different dose levels of CX-01 to standard induction therapy and consolidation therapy and 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. 160 patients will be randomized one of 4 treatment groups to receive standard induction/consolidation therapy alone or standard induction/consolidation therapy with CX-01 at one of 3 different dose levels (low, medium and high). Patients will receive up to 2 induction cycles and up to 3 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.

Inclusion Criteria:

•Newly diagnosed, de novo or secondary, previously untreated AML
•Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria:

•Acute promyelocytic leukemia
•Prior chemotherapy for AML
•Prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome
•CNS leukemia
Phase II
Cancer, All Other
Raya Mawad, M.D.
Cantex Pharmaceticals
Melinh Jones
  • Swedish Medical Center