A Phase II Open-Label Study of the Subcutaneous Administration of Homoharringtonine (Omacetaxine Mepesuccinate) in the Treatment of Patients With Chronic Myeloid Leukemia (CML) Who Have Failed or Are Intolerant to Tyrosine Kinase Inhibitor Therapy
This will be an open label, multicenter study of subcutaneous HHT (omacetaxine
mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic,
accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor
therapy. Patients will be treated with induction course cycles consisting of subcutaneous
(SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be
evaluated every 7 days with complete blood and platelet counts while undergoing induction
therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may
be adjusted, as clinically indicated, according to guidelines provided in the treatment
plan.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Achieving a Clinical Response by Subpopulation
Subpopulations reflect chronic myeloid leukemia (CML) phases: chronic, accelerated, and blast phase.
up to 6 months
No
Jorge Cortes, MD
Principal Investigator
M.D. Anderson Cancer Center
United States: Food and Drug Administration
CGX-635-CML-203
NCT00462943
March 2007
January 2014
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |
University of Maryland Greenebaum Cancer Center | Baltimore, Maryland 21201 |
The University of Texas MD Anderson Cancer Center | Houston, Texas 77030-4009 |
Indiana Bone Marrow Transplant Center | Beech Grove, Indiana 46107 |
Our Lady Mercy Cancer Center | Bronx, New York 10466 |
Fox Chase Temple BMT Program | Philadelphia, Pennsylvania 19111 |