Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00115128
First received: June 21, 2005
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.


Condition Intervention
Normal PBPC Donors
Drug: filgrastim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Spleen fold change measured by ultrasound [ Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Spleen change associations with filgrastim dose and hematologic variables [ Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

none collected


Enrollment: 309
Study Start Date: November 2003
Study Completion Date: September 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Filgrastim
Normal donors being treated with filgrastim for PBPC mobilization and collection
Drug: filgrastim
Normal donors being treated with filgrastim for PBPC mobilization and collection
Other Name: Filgrastim

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Normal donors

Criteria

Inclusion Criteria: - Eligible to be PBPC donor for allogeneic transplantation as determined by local institution Exclusion Criteria: - History of splenectomy - Previous PBPC mobilization attempts - Previous treatment with GCSF or GMCSF

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00115128

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00115128     History of Changes
Obsolete Identifiers: NCT00108966
Other Study ID Numbers: 20020143
Study First Received: June 21, 2005
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
normal PBPC donors

Additional relevant MeSH terms:
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014