GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR (Rhu-GM-CSF) FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
- Determine whether the use of sargramostim (GM-CSF) after T-cell depleted, CD34-positive
cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in
patients with chronic myelogenous leukemia.
OUTLINE: Patients receive myeloablation with busulfan and cyclophosphamide on an approved
protocol. Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody.
T-cell depleted, CD34-positive cell-supplemented bone marrow is infused on day 0. Patients
receive high-dose sargramostim (GM-CSF) subcutaneously (SC) beginning on day 5 and
continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60.
Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation
without GM-CSF is considered in case of primary or secondary engraftment failure.
Patients are followed every month for 3 months, every 3 months for 1 year, every 6 months
for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within
approximately 6-10 years.
Masking: Open Label, Primary Purpose: Treatment
B. Douglas Smith, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|