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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00115128
Enrollment
309
Registered
2005-06-22
Start date
2003-11-30
Completion date
2007-09-30
Last updated
2013-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal PBPC Donors

Keywords

normal PBPC donors

Brief summary

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

Interventions

DRUGfilgrastim

Normal donors being treated with filgrastim for PBPC mobilization and collection

Sponsors

Amgen
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Spleen fold change measured by ultrasoundBefore, during, and through 1 week post-PBPC mobilization and collection

Secondary

MeasureTime frame
Spleen change associations with filgrastim dose and hematologic variablesBefore, during, and through 1 week post-PBPC mobilization and collection

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026