HIGH-DOSE CHEMOTHERAPY FOLLOWED BY AUTOLOGOUS PERIPHERAL BLOOD STEM CELL TRANSPLANTATION FOR CHILDREN WITH RELAPSED ACUTE LYMPHOCYTIC LEUKEMIA
- Determine the efficacy of autologous peripheral blood stem cell (PBSC) transplantation
for marrow reconstitution after high-dose carmustine, cytarabine, etoposide, and
cyclophosphamide in children with relapsed acute lymphocytic leukemia.
- Determine the dose effect of autologous PBSC on engraftment in this patient population.
OUTLINE: Patients receive chemotherapy mobilization comprising cytarabine IV every 12 hours
on days 1-5. When blood counts recover, autologous peripheral blood stem cells (PBSC) are
harvested and selected for mononuclear cells, granulocyte-macrophage colony-forming units,
and CD34+ cells.
Patients receive preparative regimen comprising carmustine IV on days -8 and -3, cytarabine
IV every 12 hours and etoposide IV every 12 hours on days -7 to -4, and cyclophosphamide IV
on days -2 and -1. PBSC are reinfused on day 0. Patients receive filgrastim (G-CSF) or
sargramostim (GM-CSF) beginning after PBSC transplantation. Male patients undergo
radiotherapy to the testes before transplantation. Patients with a history of CNS leukemia
undergo craniospinal irradiation before transplantation.
Patients are followed at 100 days, 6 months, and 1 year.
PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study within 5 years.
Primary Purpose: Treatment
Bruce G. Gordon, MD
University of Nebraska
United States: Federal Government
|University of Nebraska Medical Center||Omaha, Nebraska 68198-3330|