Trials / Terminated
TerminatedNCT00695370
Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children
Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- University Hospital, Clermont-Ferrand · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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)
Detailed description
Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pegfilgrastim (drug) |
Timeline
- Start date
- 2006-01-01
- Primary completion
- 2007-12-01
- Completion
- 2008-01-01
- First posted
- 2008-06-11
- Last updated
- 2008-06-13
Source: ClinicalTrials.gov record NCT00695370. Inclusion in this directory is not an endorsement.