Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborator: Amgen

Criteria

Inclusion Criteria:

• 0 to 18 years

• solid malignancy

• Lansky score >70%

• 12 to 18 days since the beginning of the last chemotherapy cycle

• no administration of any hematopoietic growth factor in the previous 8 days

Exclusion Criteria:

• clinical or biological conditions precluding the mobilization or collection procedure