Solid Malignancies Clinical Trial
— MEG-5Official title:
Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
NCT number | NCT00751894 |
Other study ID # | CHU-0041 |
Secondary ID | |
Status | Not yet recruiting |
Phase | Phase 2 |
First received | September 11, 2008 |
Last updated | January 18, 2011 |
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
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | |
Est. primary completion date | |
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% - 12 to 18 days since the beginning of the last chemotherapy cycle - 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 |
---|---|---|---|
France | CHU | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand | Amgen |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes | |
Secondary | Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells | at least 5*10e6CD34cells | Yes |
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