Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
Acute Myeloid Leukemia
Agnogenic Myeloid Metaplasia
Leukemia, Myelomonocytic, Chronic
Drug: Dasatinib (BMS-354825)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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)|
- Participant Response Rate [ Time Frame: Baseline to completion of 4 week cycle or until disease progression ] [ Designated as safety issue: No ]Response Rate is complete response plus partial response (CR+PR) for each disease category.
- Duration of Response (Survival) [ Time Frame: Baseline, once a week for a month, thereafter monthly ] [ Designated as safety issue: No ]Response duration is from date of first response until relapse. Survival is from start of therapy. They will be done using the Kaplan-Meier estimators, the log-rank tests and the Cox-proportional hazards models.
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||November 2018|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Dasatinib 70 mg orally twice daily.
Drug: Dasatinib (BMS-354825)
70 mg orally twice daily
Other Name: Sprycel
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255346
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Hagop M Kantarjian, MD||M.D. Anderson Cancer Center|