Status:

UNKNOWN

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

Lead Sponsor:

University Hospital, Clermont-Ferrand

Collaborating Sponsors:

Amgen

Conditions:

Solid Malignancies

Eligibility:

All Genders

Up to 18 years

Phase:

PHASE2

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 cr...

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...

Eligibility Criteria

Inclusion

  • 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

  • clinical or biological conditions precluding the mobilization or collection procedure

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT00751894

Last Update

January 19 2011

Active Locations (1)

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1

CHU

Clermont-Ferrand, France, 63058