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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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