NCT00255346

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Acute Myeloid Leukemia
• Myelodysplastic Syndromes
• Agnogenic Myeloid Metaplasia
• Myelofibrosis
• Hypereosinophilic Syndrome
• Polycythemia Vera
• Mastocytosis
• Leukemia, Myelomonocytic, Chronic

Interventions

Type	Name	Description
DRUG	Dasatinib (BMS-354825)	70 mg orally twice daily

Timeline

• Start date: 2005-11-15
• Primary completion: 2017-03-03
• Completion: 2017-03-03
• First posted: 2005-11-18
• Last updated: 2025-12-30
• Results posted: 2019-05-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study