NCT00695370

Brief Summary

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)

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

Timeline
Completed

Started Jan 2006

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
Last Updated

June 13, 2008

Status Verified

June 1, 2008

Enrollment Period

1.9 years

First QC Date

June 9, 2008

Last Update Submit

June 12, 2008

Conditions

Solid Malignancies

Keywords

ChildrencancerBone marrow transplantationMobilizationG-CSFChildren with solid malignancies

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Pegfilgrastim (drug)DRUG

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%
  • 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

You may not qualify if:

  • clinical or biological conditions precluding the mobilization or collection procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neoplasms

Interventions

pegfilgrastimPharmaceutical Preparations

Study Officials

  • Etienne Merlin, MD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

January 1, 2006

Primary Completion

December 1, 2007

Study Completion

January 1, 2008

Last Updated

June 13, 2008

Record last verified: 2008-06