Leukemia Clinical Trial
Official title:
Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) and Autologous Bone Marrow Transplantation for Chronic Myeloid Leukemia
RATIONALE: Biological therapy may increase the number of immune cells found in bone marrow
and may help a person's immune system recover from the side effects of the chemotherapy used
in treating chronic myeloid leukemia. Bone marrow transplantation may be able to replace
immune cells that were destroyed by chemotherapy.
PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation,
chemotherapy, and biological therapy in treating patients who have chronic myeloid leukemia.
OBJECTIVES: I. Determine the one year event-free survival in patients with chronic phase
chronic myeloid leukemia receiving sargramostim (GM-CSF)-treated autologous bone marrow
transplantation followed by GM-CSF and interferon alfa. II. Determine the toxicity of this
regimen in these patients.
OUTLINE: Patients undergo harvesting of autologous bone marrow. A portion of the cells are
treated ex vivo with sargramostim (GM-CSF) for 3 days. Patients then receive myeloablative
chemotherapy with busulfan and cyclophosphamide on days -9 to -2 according to the
preparative regimen protocol. Patients undergo sargramostim (GM-CSF)-treated autologous bone
marrow transplantation on day 0. Patients receive GM-CSF subcutaneously daily on days 5-180,
and interferon alfa daily on days 90-180. Patients are followed monthly for 1 year, every 6
months for 2 years, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 9-19 patients will be accrued for this study within 2-3 years.
;
Primary Purpose: Treatment
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