Therapy of Myeloid Metaplasia-Myelofibrosis, Atypical Chronic Myeloid or Myelomonocytic Leukemia, C-Kit Positive Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndrome (AML-MDS), Hypereosinophilic Syndrome, Polycythemia Vera, and Mastocytosis With Dasatinib (BMS-354825)
Dasatinib is an experimental anti-cancer drug that is designed to block the function of
BCR-ABL, which is the abnormal protein responsible for causing leukemia in some cells.
If you are found to be eligible to take part in this study, you will take dasatinib by mouth
twice a day. If you have mastocytosis, you will take dasatinib by mouth once a day. A
treatment cycle will be defined as 4 weeks (28 days) + 7 days. You will be instructed to
take dasatinib in the morning (between about 6:00 a.m.-10:00 a.m.) and in the evening
(between about 6:00 p.m.-10:00 p.m.).
Blood tests (about 2 - 3 teaspoons) will be done once a week for a month, then once a month
for 5 years, then once every 6 months (if your doctor thinks it is needed) for the remainder
of your treatment on this study. A bone marrow biopsy will be done after 1-2 months of
therapy to document response.
Dasatinib will be given for as long as you are responding. You will be taken off study if
the disease gets worse or intolerable side effects occur.
This is an investigational study. Dasatinib is authorized for use in research only. A
total of 145 patients will take part in this study. All will be treated at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Participant Response Rate
Baseline to completion of 4 week cycle or until disease progression
Hagop M Kantarjian, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|