AUTOLOGOUS STEM CELL TRANSPLANTATION FOR ACUTE MYELOID LEUKEMIA IN SECOND REMISSION: A PHASE II STUDY
OBJECTIVES: I. Determine the ability of mobilization using cytarabine, etoposide, and
filgrastim (G-CSF), conditioning using busulfan and etoposide, and autologous peripheral
blood stem cell transplantation to generate a 2-year disease-free survival rate in at least
30% of patients with acute myeloid leukemia (AML) in second complete remission. II.
Determine whether the treatment-related mortality can be limited to less than 20% in
patients treated with this regimen. III. Determine whether adequate numbers of PBSC can be
collected in these patients. IV. Determine the engraftment kinetics of primed PBSC obtained
from these patients.
OUTLINE: Mobilization/harvest: Patients receive cytarabine IV over 2 hours every 12 hours
and etoposide IV continuously on days 1-4. Filgrastim (G-CSF) is administered subcutaneously
(SC) beginning on day 14 and continuing until peripheral blood stem cells (PBSC) are
harvested. When blood counts recover, PBSC are harvested and selected for CD34+ cells.
Conditioning: Beginning at least 4 weeks after hospital discharge for mobilization and
harvest and when blood counts recover, patients receive oral busulfan every 6 hours on days
-7 to -4 and etoposide IV over 4 hours on day -3. PBSC are reinfused on day 0. G-CSF is
administered SC beginning on day 0 and continuing until blood counts recover. Patients with
documented CNS disease at first relapse receive methotrexate intrathecally at intervals of 1
week or greater before and/or after PBSC transplantation for a total of 6 doses. Patients
are followed every 3 months for 2 years and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 26-48 patients will be accrued within 2 years.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease free survival
Charles A. Linker, MD
University of California, San Francisco
United States: Food and Drug Administration
|UCSF Cancer Center and Cancer Research Institute||San Francisco, California 94115-0128|
|Marlene & Stewart Greenebaum Cancer Center, University of Maryland||Baltimore, Maryland 21201|
|St. Joseph's Hospital and Medical Center||Paterson, New Jersey 07503|