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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: September 11, 2008
Last updated: January 18, 2011
Last verified: January 2011
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

Condition Intervention Phase
Solid Malignancies
Drug: Pegfilgrastim (Neulasta, Amgen)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Haematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 200µg/kg After Chemotherapy

Resource links provided by NLM:

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:
  • percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed) [ Time Frame: less than 3 blood volume processed ]

Secondary Outcome Measures:
  • Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells [ Time Frame: at least 5*10e6CD34cells ]

Estimated Enrollment: 30
Intervention Details:
    Drug: Pegfilgrastim (Neulasta, Amgen)
    sequential Bayesian study
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


Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00751894

Contact: Patrick Lacarin

CHU Not yet recruiting
Clermont-Ferrand, France, 63058
Contact: Etienne Merlin, Dr      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Etienne Merlin, DR University Hospital, Clermont-Ferrand
  More Information

Responsible Party: Dr Etienne MERLIN, CHU Clermont-Ferrand Identifier: NCT00751894     History of Changes
Other Study ID Numbers: CHU-0041
Study First Received: September 11, 2008
Last Updated: January 18, 2011

Keywords provided by University Hospital, Clermont-Ferrand:
Bone marrow transplantation
Stem cell mobilization
Children with solid malignancies

Additional relevant MeSH terms:
Neoplasms processed this record on April 27, 2017