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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Amgen
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00751894
First received: September 11, 2008
Last updated: January 18, 2011
Last verified: January 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751894

Contacts
Contact: Patrick Lacarin 04.73.75.11.95 placarin@chu-clermontferrand.fr

Locations
France
CHU Not yet recruiting
Clermont-Ferrand, France, 63058
Contact: Etienne Merlin, Dr    04.73.75.00.09      
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Amgen
Investigators
Principal Investigator: Etienne Merlin, DR University Hospital, Clermont-Ferrand
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on April 23, 2014