Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
N/A
18 Years
Both
Solid Malignancies
Trial Information
Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy
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
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)
Outcome Time Frame:
less than 3 blood volume processed
Safety Issue:
Yes
Principal Investigator
Etienne Merlin, DR
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital, Clermont-Ferrand
Authority:
France: Ministry of Health
Study ID:
CHU-0041
NCT ID:
NCT00751894
Start Date:
Completion Date:
Related Keywords:
- Solid Malignancies
- Children
- cancer
- Bone marrow transplantation
- Stem cell mobilization
- G-CSF
- Children with solid malignancies
- Neoplasms
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