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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014