Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous
chemotherapy. No hematological growth factor during the 8 previous days.
Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)
Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording
Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a
standard apheresis (less than 2 blood volume processed)
Analysis: sequential Bayesian study
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Etienne Merlin, MD
Principal Investigator
University Hospital, Clermont-Ferrand
France: Ministry of Health
CHU-0035
NCT00695370
January 2006
January 2008
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