Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
NCT ID: NCT00695370
Last Updated: 2008-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2006-01-31
2008-01-31
Brief Summary
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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)
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
TREATMENT
NONE
Interventions
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Pegfilgrastim (drug)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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CHU Clermont-Ferrand
Principal Investigators
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Etienne Merlin, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Other Identifiers
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CHU-0035
Identifier Type: -
Identifier Source: org_study_id
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