Solid Malignancies
Conditions
Keywords
Children, cancer, Bone marrow transplantation, Mobilization, G-CSF, Children with solid malignancies
Brief 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
Interventions
Sponsors
Amgen
University Hospital, Clermont-Ferrand
Study design
Allocation
NON_RANDOMIZED
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* 0 to 18 years * solid malignancy * Lansky score \>70% * more than 17 days since the beginning of the last chemotherapy cycle * absolute neutrophil count (ANC) greater than 1×109/l * no administration of any hematopoietic growth factor in the previous 8 days
Exclusion criteria
* clinical or biological conditions precluding the mobilization or collection procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed) | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells | — |
Outcome results
None listed