751894
Last Update Posted: 2011-01-19
Recruiting status is unknown
All Genders accepted | Under 18 Years |
30 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
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
Eligibility
Relevant conditions:
Solid Malignancies
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.
locations
Contact Information
Overall Contact
Patrick Lacarin
placarin@chu-clermontferrand.fr
04.73.75.11.95
Data sourced from ClinicalTrials.gov