Pegfilgrastim for Stem Cell Mobilization in Children (Meg-5)

Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00751894

Acronym

MEG-5

Enrollment

Registered

2008-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2011-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Malignancies

Keywords

Children, cancer, Bone marrow transplantation, Stem cell mobilization, G-CSF, Children with solid malignancies

Brief summary

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

Detailed description

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

Interventions

DRUGPegfilgrastim (Neulasta, Amgen)

sequential Bayesian study

Study design

Allocation

NON_RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Secondary

Measure	Time frame
Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells	at least 5*10e6CD34cells

Countries

France

Contacts

Primary ContactPatrick Lacarin

placarin@chu-clermontferrand.fr04.73.75.11.95

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026