Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)
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|ClinicalTrials.gov Identifier: NCT00255346|
Recruitment Status : Completed
First Posted : November 18, 2005
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Myelodysplastic Syndromes Agnogenic Myeloid Metaplasia Myelofibrosis Hypereosinophilic Syndrome Polycythemia Vera Mastocytosis Leukemia, Myelomonocytic, Chronic||Drug: Dasatinib (BMS-354825)||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||68 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Actual Study Start Date :||November 15, 2005|
|Actual Primary Completion Date :||March 3, 2017|
|Actual Study Completion Date :||March 3, 2017|
Dasatinib 70 mg orally twice daily.
Drug: Dasatinib (BMS-354825)
70 mg orally twice daily
Other Name: Sprycel
- Participant Response Rate [ Time Frame: Baseline to completion of 4 week cycle or until disease progression ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|