Leukemia Clinical Trial
Official title:
Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy
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.
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