Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 60
Updated:6/15/2017
Start Date:February 1997
End Date:January 2022
Contact:Christine Jacox
Email:christine.jacox@nmdp.org
Phone:612-627-8130

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

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

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.

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.
We found this trial at
55
sites
801 7th Avenue
Fort Worth, Texas 76104
(682) 885-4000
Cook Children's Medical Center Cook Children's Health Care System is a not-for-profit, nationally recognized pediatric...
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Boca Raton, Florida 33431
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3500 Gaston Avenue
Dallas, Texas 75246
1.800.422.9567
Baylor University Medical Center Baylor University Medical Center in Dallas, TX is ranked nationally in...
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4039 W Newberry Rd
Gainesville, Florida 32607
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1700 State Road 7
Lauderhill, Florida 33313
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Orlando, Florida 32809
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Appleton, Wisconsin 54914
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Bedford, Texas 76021
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Boston, Massachusetts 02115
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Brooklyn, New York 11201
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Charlotte, North Carolina 28269
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Chattanooga, Tennessee 37403
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Cleveland, Ohio 44131
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Dayton, Ohio 45402
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Denver, Colorado 80230
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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East Lansing, Michigan 48823
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Glenview, Illinois 60025
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Grand Rapids, Michigan 49501
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Guaynabo, 00968
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Honolulu, Hawaii 96817
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Houston, Texas 77054
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Indianapolis, Indiana 46208
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Iowa City, Iowa 52242
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Jackson, Mississippi 39216
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Johnson City, Tennessee 37604
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529 S Jackson St
Louisville, Kentucky 40202
(502) 562-4369
James Graham Brown Cancer Center No one should feel compelled to leave Kentucky to seek...
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Milwaukee, Wisconsin 53233
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Minneapolis, Minnesota 55413
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New York, New York 10016
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Oradell, New Jersey 07649
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Philadelphia, Pennsylvania 19123
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Pittsburgh, Pennsylvania 15220
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Providence, Rhode Island 02908
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Rockville, Maryland 20892
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Rockville, Maryland 20852
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10100 Doctor Martin Luther King Junior Street North
Saint Petersburg, Florida 33716
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San Antonio, Texas 78201
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384 West Orange Show Road
San Bernardino, California 92408
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San Diego, California 92103
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Santa Ana, California 92705
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Seattle, Washington 98104
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Spokane, Washington 99201
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Temple, Texas 76508
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Urbana, Illinois 61801
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Washington, D.C., District of Columbia 20004
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West Hartford, Connecticut 06110
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Worcester, Massachusetts 01655
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