Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state provides an efficient stem cell mobilization in children with malignancies Design: phase 2 study. Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells
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