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Pegfilgrastim for stem cell mobilization in children with solid malignancies
NCT00695370Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2006
- Primary completion
- Dec 2007
- Modality
- Recombinant Proteins and Enzymes
- Drugs
- pegfilgrastim
- Conditions
- solid malignancy
01
Overview
Phase 2, open-label trial of pegfilgrastim in solid malignancy, sponsored by Centre Hospitalier Universitaire de Clermont-Ferrand. Primary endpoint: Percentage of children achieving at least 5x10e6 CD34 cells. Started Jan 2006; status: terminated.
02
Design
- Study design
- Non-randomizedOpen-labelSingle group
03
Who it enrols
Children (0-18 years) with solid malignancies, Lansky score > 70%, at least 17 days post-chemotherapy, ANC > 1x10^9/l, and no growth factors in the last 8 days.
04
Endpoints
Primary
Percentage of children achieving at least 5x10e6 CD34 cells
Secondary
Side effects
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