Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

• Status: Terminated
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

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)

• 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%

• more than 17 days since the beginning of the last chemotherapy cycle

• absolute neutrophil count (ANC) greater than 1×109/l

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

Exclusion Criteria:

• clinical or biological conditions precluding the mobilization or collection procedure