Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo Cyclophosphamide/G-CSF Priming
- Assess the clinical outcomes, survival, and morbidity of patients with chronic or
accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and
filgrastim (G-CSF) followed by autologous peripheral blood stem cell transplantation.
- Determine whether priming with cyclophosphamide and filgrastim (G-CSF) increases the
fraction of benign Philadelphia chromosome negative hematopoietic progenitors in
peripheral blood stem cells (PBSC) and reduces the incidence of persistent or recurrent
leukemia after autologous transplantation with mobilized PBSC in these patients.
OUTLINE: Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on
day 1 and filgrastim (G-CSF) daily subcutaneously (SQ) starting on day 5 and continuing
until completion of leukapheresis. Peripheral blood stem cells (PBSC) are collected between
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV
over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1.
Patients receive the PBSC transplantation on day 0. Patients also receive G-CSF IV starting
on day 0 and continuing until blood counts recover. Patients then receive interferon alfa SQ
daily in the absence of unacceptable toxicity or disease progression.
Patients are followed at 3 weeks; then at 3, 6, 9, 12, and 18 months; and then annually for
PROJECTED ACCRUAL: Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to hemopoietic recovery after transplantation
Catherine M. Verfaillie, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|