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CompletedNCT00115128Updated May 13, 2013

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

An observational study in Normal PBPC Donors, sponsored by Amgen. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-13.

Sponsored by Amgen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
309
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Normal PBPC Donors

Keywords

  • normal PBPC donors
03

In context

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Normal donors

Eligibility 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

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
309 participants (actual)
Biospecimen retention
None retained

Groups and cohorts

  • Filgrastim

    Normal donors being treated with filgrastim for PBPC mobilization and collection

    Drug: filgrastim

Interventions

  • Drugfilgrastim

    Normal donors being treated with filgrastim for PBPC mobilization and collection

06

What researchers measure

Primary outcomes

  1. Spleen fold change measured by ultrasound

    Time frame: Before, during, and through 1 week post-PBPC mobilization and collection

Secondary outcomes

  1. Spleen change associations with filgrastim dose and hematologic variables

    Time frame: Before, during, and through 1 week post-PBPC mobilization and collection

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Stiff PJ, Bensinger W, Abidi MH, Gingrich R, Artz AS, Nademanee A, Hansen KS, Sobczak C, Cutler C, Bolwell B, Shore TB, Lazarus HM, Yeager AM, Lovelace W, Guo M, Dreiling L. Clinical and ultrasonic evaluation of spleen size during peripheral blood progenitor cell mobilization by filgrastim: results of an open-label trial in normal donors. Biol Blood Marrow Transplant. 2009 Jul;15(7):827-34. doi: 10.1016/j.bbmt.2009.03.015. PubMed 19539214 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Nov 2003, a primary completion of May 2007 and a completion of Sep 2007. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 21, 2005
First posted
Jun 22, 2005
Start
Nov 2003
Primary completionActual
May 2007
CompletionActual
Sep 2007
Last update
May 13, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00115128
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Jun 22, 2005
Start date
Nov 2003
Primary completion
May 2007
Completion
Sep 2007
Last update
May 13, 2013

Study contacts

MD
study director · Amgen
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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