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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00115128
First received: June 21, 2005
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Normal PBPC Donors
Drug: filgrastim

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Open-Label Trial of Peripheral Blood Progenitor Cell (PBPC) Mobilization by Filgrastim in Normal Donors

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Spleen fold change measured by ultrasound [ Time Frame: Before, during, and through 1 week post-PBPC mobilization and collection ] [ Designated as safety issue: Yes ]

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

Biospecimen Retention:   None Retained

none collected


Enrollment: 309
Study Start Date: November 2003
Study Completion Date: September 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
Other Name: Filgrastim

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00115128

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00115128     History of Changes
Obsolete Identifiers: NCT00108966
Other Study ID Numbers: 20020143
Study First Received: June 21, 2005
Last Updated: May 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
normal PBPC donors

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

ClinicalTrials.gov processed this record on October 19, 2014