NCT00751894

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
Last Updated

January 19, 2011

Status Verified

January 1, 2011

First QC Date

September 11, 2008

Last Update Submit

January 18, 2011

Conditions

Solid Malignancies

Keywords

ChildrencancerBone marrow transplantationStem cell mobilizationG-CSFChildren with solid malignancies

Outcome Measures

Primary Outcomes (1)

  • percentage of children achieving at least 5x10e6 CD34 cells with a standard apheresis (less than 3 blood volume processed)

    less than 3 blood volume processed

Secondary Outcomes (1)

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

    at least 5*10e6CD34cells

Interventions

Pegfilgrastim (Neulasta, Amgen)DRUG

sequential Bayesian study

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • to 18 years
  • solid malignancy
  • Lansky score \>70%
  • to 18 days since the beginning of the last chemotherapy cycle
  • no administration of any hematopoietic growth factor in the previous 8 days

You may not qualify if:

  • clinical or biological conditions precluding the mobilization or collection procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Clermont-Ferrand, 63058, France

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pegfilgrastim

Study Officials

  • Etienne Merlin, DR

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Lacarin

CONTACT

04.73.75.11.95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Last Updated

January 19, 2011

Record last verified: 2011-01

Locations

FR(1)