Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors - Full Text View

Sponsored by:	Center for International Blood and Marrow Transplant Research
Information provided by:	Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:	NCT00785525

Purpose

The purpose of the study is to:

Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors
Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis
Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients
Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors

Condition	Intervention	Phase
Healthy	Drug: Filgrastim	Phase III

Drug Information available for: Filgrastim Granulocyte colony-stimulating factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Single Group Assignment
Official Title:	Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation With Unrelated Donors

Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:

Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors. [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients [ Time Frame: Ongoing ] [ Designated as safety issue: Yes ]
Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

Estimated Enrollment:	10000
Study Start Date:	February 1997
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.

Detailed Description:

For many years, allogeneic bone marrow transplantation has been used to successfully treat leukemias, other hematologic conditions and congenital disorders. The first unrelated donor transplants were performed in the late 1970s, but this procedure did not become widely available until the development of several consolidated unrelated donor registries around the world. The National Marrow Donor Program, established in 1987, is the world's largest registry and currently lists more than 7 million donors. Since its beginning, NMDP has facilitated more than 30,000 unrelated transplants.

Although not a licensed indication, considerable experience has been accumulated concerning administration of filgrastim to normal adults. Most of these adults were volunteer research subjects or donors of PBSC for use in related donor transplants. Beginning in February 1997, filgrastim stimulated PBSC have been collected from NMDP donors under protocol. The protocol (locally referred to as G2) began under an NMDP-sponsored Investigational New Drug (IND) application filed with FDA for collecting PBSC for a second donation following an initial donation of bone marrow. In 1999 a second protocol was opened (locally referred to as G1) as requests for PBSC as a primary donation source became more common. In 2005 the two protocols were combined to eliminate redundancy and provide for ease of use.

The protocol 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 protocol also describes procedures for the collection of PBSC products by leukapheresis and includes provisions for long term 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:

PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations.

Exclusion Criteria:

Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose.
Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
History of autoimmune disorders, including rheumatic diseases 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.
History of iritis or episcleritis.
Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation.
Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully 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: NCT00785525

Contacts

Contact: Kathleen Delaney, CCRP	612.884.8631	kdelane2@nmdp.org
Contact: Rebecca Drexler	612.884.8654	rdrexler@nmdp.org

Show 55 Study Locations

Sponsors and Collaborators

Center for International Blood and Marrow Transplant Research

Investigators

Principal Investigator:

John P Miller, MD, PhD

National Marrow Donor Program

More Information

Donors from this study are drawn from a pool of members on the Registry. Click on the link and read more about our program. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	National Marrow Donor Program ( John P. Miller, MD, PhD )
Study ID Numbers:	PBSC
Study First Received:	November 3, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00785525
Health Authority:	United States: Food and Drug Administration

Keywords provided by Center for International Blood and Marrow Transplant Research:

Healthy Unrelated Stem Cell Donors

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009