Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors
May 10, 2013 updated by: Amgen
The purpose of this study is to clinically evaluate the spleen during PBPC mobilization by filgrastim in normal donors.
Study Overview
Study Type
Observational
Enrollment (Actual)
309
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Normal donors
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Filgrastim
Normal donors being treated with filgrastim for PBPC mobilization and collection
|
Normal donors being treated with filgrastim for PBPC mobilization and collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Spleen fold change measured by ultrasound
Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection
|
Before, during, and through 1 week post-PBPC mobilization and collection
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Spleen change associations with filgrastim dose and hematologic variables
Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection
|
Before, during, and through 1 week post-PBPC mobilization and collection
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2003
Primary Completion (ACTUAL)
May 1, 2007
Study Completion (ACTUAL)
September 1, 2007
Study Registration Dates
First Submitted
June 21, 2005
First Submitted That Met QC Criteria
June 21, 2005
First Posted (ESTIMATE)
June 22, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 10, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20020143
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.