Summary

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

Description

Summary

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

Details

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.

Keywords

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

Eligibility

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

Locations

  • University of California, San Diego, Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • LDS Hospital accepting new patients
    Salt Lake City Utah 84143 United States
  • Huntsman Cancer Institute accepting new patients
    Salt Lake City Utah 84112 United States
  • New Mexico Cancer Care Alliance accepting new patients
    Albuquerque New Mexico 87131 United States
  • Colorado Blood Cancer Institute accepting new patients
    Denver Colorado 80218 United States
  • Oregon Health & Science University Knight Cancer Institute accepting new patients
    Portland Oregon 97239 United States
  • Swedish Cancer Institute withdrawn
    Seattle Washington 98122 United States
  • Methodist Healthcare System of San Antonio accepting new patients
    San Antonio Texas 78229 United States
  • Baylor Research Institute/Baylor Sammons Cancer Center/Baylor University Medical Center accepting new patients
    Dallas Texas 75246 United States
  • June E. Nylen Cancer Center accepting new patients
    Sioux City Iowa 51101 United States
  • Avera Cancer Institute accepting new patients
    Sioux Falls South Dakota 57105 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Cantex Pharmaceuticals
ID
NCT02873338
Phase
Phase 2
Study Type
Interventional
Last Updated
August 3, 2018