A Phase II Study of Decitabine in Myelofibrosis
I. Determine response rate (complete and partial response and hematological improvement) in
patients with myeloid metaplasia with myelofibrosis treated with decitabine.
II. Determine the safety of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive decitabine subcutaneously on days 1-5 and 8-12. Treatment repeats every 42
days in the absence of disease progression or unacceptable toxicity.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate (complete response, partial response, hematologic improvement)
The 95% confidence intervals should be provided.
Until relapse or disease progression
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Oncology Care Associates PLLC||St. Joseph, Michigan 49085|
|Southern Illinois University||Springfield, Illinois 62702|