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

Completed

• Conditions: Normal PBPC Donors
• Interventions: Drug: filgrastim

• Registration Number: NCT00115128
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-11
• Study First Submitted: 2005-06-21
• Study First Submitted QC: 2005-06-21
• Study First Posted: 2005-06-22
• Primary Completion: 2007-05
• Study Completion: 2007-09
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-10
• Last Update Posted: 2013-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 309

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Filgrastim	filgrastim	Normal donors being treated with filgrastim for PBPC mobilization and collection

Primary Outcome Measures

Name	Time	Method
Spleen fold change measured by ultrasound	Before, during, and through 1 week post-PBPC mobilization and collection

Secondary Outcome Measures

Name	Time	Method
Spleen change associations with filgrastim dose and hematologic variables	Before, during, and through 1 week post-PBPC mobilization and collection