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| Name | Class |
|---|---|
| Amgen | INDUSTRY |
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
Patients: consecutively referred for HSC mobilization. 12 to 18 days after the previous chemotherapy. No haematological growth factor during the 8 previous days.
Mobilization: one sc injection of 200 µg/kg pegfilgrastim (Neulasta, Amgen) Evaluation during the study: CD34 circulating cells from day 3 to day 7 ; AE recording Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) Analysis: sequential Bayesian study
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegfilgrastim (Neulasta, Amgen) | Drug | sequential Bayesian study |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells | at least 5*10e6CD34cells |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick Lacarin | Contact | 04.73.75.11.95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Etienne Merlin, DR | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Clermont-Ferrand | 63058 | France |
|
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C455861 | pegfilgrastim |
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