Spots Global Cancer Trial Database for Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
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Trial Identification
Brief Title: Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
Official Title: Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
Study ID: NCT00751894
Conditions
Interventions
Study Description
Brief Summary: 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
Detailed Description: 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
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
CHU, Clermont-Ferrand, , France
Contact Details
Name: Etienne Merlin, DR
Affiliation: University Hospital, Clermont-Ferrand
Role: PRINCIPAL_INVESTIGATOR
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