Solid Malignancies Clinical Trial
Official title:
Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
Hypothesis : pegfilgrastim at 200 µg/kg between 12 and 18 days after previous chemotherapy 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 3 blood volume processed
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous
chemotherapy. No haematological growth factor during the 8 previous days.
Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation
during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment
criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard
apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
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