for people ages 60 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion



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.

Official Title

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


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.


Acute Myeloid Leukemia Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Cytarabine Idarubicin Idarubicin + Cytarabine Idarubicin+Cytarabine+lower dose CX-01 Idarubicin+Cytarabine+higher dose CX-01


You can join if…

Open to people ages 60 years and up

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

You CAN'T join if...

  • Acute promyelocytic leukemia
  • Prior chemotherapy for AML
  • Prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome
  • CNS leukemia


  • University of California, San Diego, Moores Cancer Center
    La Jolla California 92093 United States
  • Huntsman Cancer Institute
    Salt Lake City Utah 84112 United States
  • LDS Hospital
    Salt Lake City Utah 84143 United States


in progress, not accepting new patients
Start Date
Completion Date
Cantex Pharmaceuticals
Phase 2
Study Type
Last Updated