Status:
TERMINATED
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
Amgen
Conditions:
Solid Malignancies
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE2
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 ...
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 3...
Eligibility Criteria
Inclusion
- 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
- clinical or biological conditions precluding the mobilization or collection procedure
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00695370
Start Date
January 1 2006
End Date
January 1 2008
Last Update
June 13 2008
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