Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

This study has been completed.

First Received: August 3, 2007 Last Updated: March 3, 2008 History of Changes

Sponsor:	University of California, San Francisco
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00511550

Purpose

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.

Condition
Healthy

Study Type:	Observational
Study Design:	Prospective
Official Title:	Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Resource links provided by NLM:

Drug Information available for: Filgrastim

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Estimated Enrollment:	15
Study Start Date:	August 2005
Estimated Study Completion Date:	November 2007

Detailed Description:

This study establishes and evaluates a system to supply peripheral blood stem cell (PBSC)products for use in unrelated donor hematopoietic stem cell (HSC) transplantation. The protocol describes processes for donor identification, education and evaluation. Procedures for administration and monitoring of the stem cell mobilizing agent filgrastim are included. The study also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for indefinite donor follow-up.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

-Healthy adults

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511550

Locations

United States, California
University of California San Francisco Medical Center
San Francisco, California, United States, 94143-0324

Sponsors and Collaborators

University of California, San Francisco

Investigators

Principal Investigator:	Thomas G. Martin, M.D.	University of California, San Francisco
Study Director:	John Miller, M.D.,Ph.D.	National Marrow Donor Program

More Information

Additional Information:

UCSF Cancer Center Clinical Trial Search Page This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	UC-2508
Study First Received:	August 3, 2007
Last Updated:	March 3, 2008
ClinicalTrials.gov Identifier:	NCT00511550 History of Changes
Health Authority:	United States: UCSF Cancer Center Data Safety Monitoring Committee; United States: National Marrow Donor Program

Keywords provided by University of California, San Francisco:

peripheral blood stem cells
filgrastim-mobilized
allogeneic transplantation
Unrelated Donors for allogeneic transplantation

ClinicalTrials.gov processed this record on November 27, 2009