RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia. PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.
OBJECTIVES: * Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy. OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 weeks. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States
CCOP - Bay Area Tumor Institute
Oakland, California, United States
Cytogenetic response (complete and partial)
Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Time to progression
Survival
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