Granulocyte-Macrophage Colony Stimulating Factor (Rhu-GM-CSF) and Autologous Bone Marrow Transplantation for 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
B. Douglas Smith, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Johns Hopkins Oncology Center||Baltimore, Maryland 21287|