Leukemia Clinical Trial
Official title:
Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) With Interferon-Alpha (IFN-alpha) for Chronic Myeloid Leukemia
RATIONALE: Interferon alfa may interfere with the growth of cancer cells. Colony-stimulating
factors such as sargramostim may increase the number of immune cells found in bone marrow or
peripheral blood and may help a person's immune system recover from the side effects of
therapy. Combining sargramostim with interferon alfa may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of sargramostim in treating patients who
are receiving interferon alfa for chronic phase chronic myelogenous leukemia that is in
remission.
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.
;
Primary Purpose: Treatment
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