A Pilot Study of High Dose Busulfan Combined With IL2/GM-CSF Activated Autologous/Syngeneic PBSC, Sequential IL2/GM-CSF Therapy and Alpha Interferon Maintenance Therapy as Treatment of CML
OBJECTIVES: I. Determine the toxicity of high-dose busulfan followed by interleukin-2 (IL-2)
and sargramostim (GM-CSF) activated autologous/syngeneic peripheral blood stem cell (PBSC)
transplantation, sequential IL-2 and GM-CSF therapy, and interferon alfa in patients with
chronic myelogenous leukemia. II. Determine engraftment potential of IL-2/GM-CSF activated
PBSC followed by sequential IL-2/GM-CSF therapy in this patient population. III. Assess the
time to cytogenetic and/or morphologic relapse, overall event-free survival, and overall
survival in these patients treated with this regimen.
OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and activated with
interleukin-2 (IL-2) and sargramostim (GM-CSF) on another protocol. Patients receive oral
busulfan every 6 hours on days -6 to -3 for a total of 16 doses. IL-2 and GM-CSF-activated
PBSC are reinfused on day 0. Beginning 4 hours after PBSC infusion, patients receive IL-2 IV
continuously for 5 days followed by 2 days of rest for 4 weeks. In addition, GM-CSF is
administered subcutaneously (SC) every Monday, Wednesday, and Friday for 4 weeks. Upon
hematologic recovery, but no earlier than 2 weeks after IL-2 and GM-CSF, patients receive
interferon alfa SC 3 times weekly until clear evidence of disease progression. Patients are
followed every 6 months for 3 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 2-3 years.
Primary Purpose: Treatment
Leona A. Holmberg, MD, PhD
Fred Hutchinson Cancer Research Center
United States: Federal Government
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|University of Colorado Cancer Center||Denver, Colorado 80262|