Spots Global Cancer Trial Database for Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
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Trial Identification
Brief Title: Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
Official Title: Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
Study ID: NCT00695370
Conditions
Interventions
Study Description
Brief Summary: 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)
Detailed Description: 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
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Contact Details
Name: Etienne Merlin, MD
Affiliation: University Hospital, Clermont-Ferrand
Role: PRINCIPAL_INVESTIGATOR
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