Solid Malignancies Clinical Trial
Official title:
Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
Verified date | June 2008 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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)
Status | Terminated |
Enrollment | 30 |
Est. completion date | January 2008 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 18 Years |
Eligibility |
Inclusion Criteria: - 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 Criteria: - clinical or biological conditions precluding the mobilization or collection procedure |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Amgen |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed) | |||
Secondary | Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells |
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