NCT00511550

Brief Summary

Peripheral blood stem cells (PBSCs) collected following stimulation with filgrastim are commonly used for autologous hematopoietic transplants. PBSCs are also now being used for some syngeneic and allogeneic hematopoietic transplants involving HLA-matched sibling donors. However, many issues remain unanswered about the use of PBSCs for allogeneic transplants and the effects of filgrastim on healthy individuals. The purpose of this study is to determine the effectiveness of filgrastim stimulated PBSCs in hematopoietic cell transplants involving unrelated donors and to determine the effects of this donation process on unrelated stem cell donors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 6, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

March 5, 2008

Status Verified

July 1, 2007

First QC Date

August 3, 2007

Last Update Submit

March 3, 2008

Conditions

Healthy

Keywords

peripheral blood stem cellsfilgrastim-mobilizedallogeneic transplantationUnrelated Donors for allogeneic transplantation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults

You may not qualify if:

  • Pregnancy or uninterruptible breastfeeding.
  • Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
  • History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
  • History of deep vein thrombosis or pulmonary embolism.
  • Thrombocytopenia \<150 x 10(9)/L (\<150,000/uL) at baseline evaluation.
  • Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated.
  • Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test.
  • Donors receiving experimental therapy or investigational agents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Francisco Medical Center

San Francisco, California, 94143-0324, United States

Location

Study Officials

  • Thomas G. Martin, M.D.

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • John Miller, M.D.,Ph.D.

    National Marrow Donor Program

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 3, 2007

First Posted

August 6, 2007

Study Start

August 1, 2005

Study Completion

November 1, 2007

Last Updated

March 5, 2008

Record last verified: 2007-07

Locations

US(1)