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

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ClinicalTrials.gov Identifier: NCT00751894
Recruitment Status : Unknown
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Not yet recruiting
First Posted : September 12, 2008
Last Update Posted : January 19, 2011
Sponsor:
Collaborator:
Amgen
Information provided by:
University Hospital, Clermont-Ferrand

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

Condition or disease Intervention/treatment Phase
Solid Malignancies Drug: Pegfilgrastim (Neulasta, Amgen) Phase 2

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


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Masking: None (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 the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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 :
  1. Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells [ Time Frame: at least 5*10e6CD34cells ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Dr Etienne MERLIN, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00751894     History of Changes
Other Study ID Numbers: CHU-0041
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: January 2011

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