The goal of this clinical research study is to learn if dasatinib can help to control myeloproliferative disorders. The safety and tolerability of dasatinib will also be studied.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
70 mg orally twice daily
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Participant Response Rate
Response Rate is complete response plus partial response (CR+PR) for each disease category. Response Evaluation Criteria are as follows: Systemic Mastocytosis (SM): CR is the improvement of C-Findings, Tryptase \<20, and no organomegaly. PR is the improvement of C-Findings. Acute Myeloid Leukemia (AML)/MDS and CMML: CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. PR is bone marrow blasts 6-25% but decreased by \> 50% and absolute neutrophil count, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. Primary Myelofibrosis (PMF): CR is bone marrow blasts \</= 5%, absolute neutrophil count (ANC) \>/= 1000 and platelets \>/= 100. CR is PR plus one or more of the following: ANC \>/= 1000, decreased platelets by 50%, hemoglobin increase of 2g/dl or reduction splenomegaly and/or hepatomegaly by 50%. HES/CEL: CR is disappearance of eosinophilia \</= 10%, PR is reduction of eosinophilia by \>/= 50%
Time frame: Baseline to completion of 4 week cycle or until disease progression
Duration of Response (Survival)
Response date to loss of response or last follow up.
Time frame: Baseline, once a week for a month, thereafter monthly, up to 10 years
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