Evaluation of Pegfilgrastim for Stem Cell Mobilization in Children

This study has been terminated.
(Recruiting or enrolling participants has halted and will not resume)
Sponsor:
Collaborator:
Amgen
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00695370
First received: June 9, 2008
Last updated: June 12, 2008
Last verified: June 2008
  Purpose

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

  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%
  • 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
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: NCT00695370

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

No publications provided

Responsible Party: Dr Etienne MERLIN, CHU Clermont-Ferrand
ClinicalTrials.gov 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:
Children
cancer
Bone marrow transplantation
Mobilization
G-CSF
Children with solid malignancies

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 16, 2014