Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

This study has been terminated.
(Recruiting or enrolling participants has halted and will not resume)
Information provided by:
University Hospital, Clermont-Ferrand Identifier:
First received: June 9, 2008
Last updated: June 12, 2008
Last verified: June 2008

Hypothesis: pegfilgrastim at 300 µg/kg in hematological steady state 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 2 blood volume processed)

Condition Intervention Phase
Solid Malignancies
Drug: Pegfilgrastim (drug)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hematopoietic Progenitor Cell Mobilization in Children With Malignancies: Evaluation of Pegfilgrastim at 300µg/kg in Hematological Steady State

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 2 blood volume processed)

Secondary Outcome Measures:
  • Side effects Number of apheresis required to achieved a graft of at least 5x10e6 CD34 cells

Estimated Enrollment: 30
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

Patients: consecutively referred for HSC mobilization. At least 17 days after the previous chemotherapy. No hematological growth factor during the 8 previous days.

Mobilization: one sc injection of 300 µg/kg pegfilgrastim (Neulasta, Amgen)

Evaluation during the study: CD34 circulating cells from day 2 to day 7 ; AE recording

Judgment criterion: percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 2 blood volume processed)

Analysis: sequential Bayesian study


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

Inclusion Criteria:

  • 0 to 18 years
  • solid malignancy
  • Lansky score >70%
  • more than 17 days since the beginning of the last chemotherapy cycle
  • absolute neutrophil count (ANC) greater than 1×109/l
  • 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: NCT00695370

Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Principal Investigator: Etienne Merlin, MD University Hospital, Clermont-Ferrand
  More Information

No publications provided

Responsible Party: Dr Etienne MERLIN, CHU Clermont-Ferrand Identifier: NCT00695370     History of Changes
Other Study ID Numbers: CHU-0035
Study First Received: June 9, 2008
Last Updated: June 12, 2008
Health Authority: France: Ministry of Health

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

Additional relevant MeSH terms:
Neoplasms processed this record on February 27, 2015