Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Syndrome

Leukemia

Mastocytosis

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloproliferative Disorders

Polycythemia Vera

Polycythemia

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Metaplasia

Leukemia, Myelomonocytic, Chronic

Hypereosinophilic Syndrome

Neoplasms by Histologic Type

Hematologic Diseases

Bone Marrow Diseases

Precancerous Conditions

Bone Marrow Neoplasms

Hematologic Neoplasms

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Eosinophilia

Leukocyte Disorders

Myelodysplastic-Myeloproliferative Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Chronic Graft Versus Host Disease

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Chronic Myelomonocytic Leukemia

Myelodysplastic/myeloproliferative Disease

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Dasatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Dasatinib (BMS-354825)

Hagop M Kantarjian, MD

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.

Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)

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)

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%

Response date to loss of response or last follow up.

Bristol-Myers Squibb

M.D. Anderson Cancer Center

Dasatinib 70 mg orally twice daily.

Dasatinib (BMS-354825): 70 mg orally twice daily

Dasatinib All Patient Groups

Acute Myeloid Leukemia (AML)

MDS/CMML

HES/CEL

Primary Myelofibrosis (PMF)

Systemic Mastocytosis (SM)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

The outcome measures were collected and reported by participant diagnosis group. The Other Adverse Events and Serious Adverse Events were collected and recorded as a group for all participants registered on the study.

Hagop Kantarjian, MD/Department Chair

Participant Response Rate

The number of participants analyzed for duration of response reflects the number of participants with a response for each arm.

Duration of Response (Survival)

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center
Dasatinib as Therapy for Myeloproliferative Disorders (MPDs)	NCT00255346	Acute Myeloid L... Myelodysplastic... Agnogenic Myelo... Myelofibrosis Hypereosinophil... Polycythemia Ve... Mastocytosis Leukemia, Myelo...	Dasatinib (BMS-...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for hypereosinophilic syndrome (hes)