Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia
OBJECTIVES: I. Estimate the rate of major cytogenetic responses to sargramostim (GM-CSF) and
interferon alfa in patients with newly diagnosed chronic phase chronic myeloid leukemia. II.
Estimate the dosing, schedule, and toxic effects of GM-CSF plus interferon alfa in these
patients.
OUTLINE: All patients are in hematologic remission on subcutaneous interferon alfa upon
entering the study. Once a complete hematologic response is achieved and the interferon alfa
dose has been stable for 14 days, patients receive subcutaneous sargramostim (GM-CSF) daily
for 6 months. Patients are followed at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: Approximately 48 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Richard J. Jones, MD
Study Chair
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
CDR0000066625
NCT00003561
February 1998
August 2010
Name | Location |
---|---|
Johns Hopkins Oncology Center | Baltimore, Maryland 21287 |