Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)
- Conditions
- Solid Malignancies
- Registration Number
- NCT00751894
- Lead Sponsor
- University Hospital, Clermont-Ferrand
- Brief 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
- Detailed Description
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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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
- 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 3 blood volume processed) less than 3 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 at least 5*10e6CD34cells
Trial Locations
- Locations (1)
CHU
🇫🇷Clermont-Ferrand, France