Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
- Conditions
- Solid Malignancies
- Registration Number
- NCT00695370
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- 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 of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
- 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 300 µg/kg pegfilgrastim (Neulasta, Amgen)
Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording
Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
Analysis: sequential Bayesian study
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 30
- 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
- clinical or biological conditions precluding the mobilization or collection procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)
- Secondary Outcome Measures
Name Time Method Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells