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

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ClinicalTrials.gov Identifier: NCT00115128
Recruitment Status : Completed
First Posted : June 22, 2005
Last Update Posted : May 13, 2013
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment
Normal PBPC Donors Drug: filgrastim

Study Type : Observational
Actual Enrollment : 309 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
Study Start Date : November 2003
Actual Primary Completion Date : May 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. Spleen fold change measured by ultrasound [ Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection ]

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

Biospecimen Retention:   None Retained
none collected


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00115128


Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Publications of Results:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00115128     History of Changes
Obsolete Identifiers: NCT00108966
Other Study ID Numbers: 20020143
First Posted: June 22, 2005    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013

Keywords provided by Amgen:
normal PBPC donors

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