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

Use our guide to learn which trials are right for you!

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
?
mi
from
Oakland, CA
Click here to add this to my saved trials
Boca Raton, Florida 33431
?
mi
from
Boca Raton, FL
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
4039 W Newberry Rd
Gainesville, Florida 32607
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
1700 State Road 7
Lauderhill, Florida 33313
?
mi
from
Lauderhill, FL
Click here to add this to my saved trials
Orlando, Florida 32809
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Appleton, Wisconsin 54914
?
mi
from
Appleton, WI
Click here to add this to my saved trials
Bedford, Texas 76021
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brooklyn, New York 11201
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28269
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chattanooga, Tennessee 37403
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
Cleveland, Ohio 44131
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Dayton, Ohio 45402
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Denver, Colorado 80230
?
mi
from
Denver, CO
Click here to add this to my saved trials
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...
?
mi
from
Duarte, CA
Click here to add this to my saved trials
East Lansing, Michigan 48823
?
mi
from
East Lansing, MI
Click here to add this to my saved trials
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...
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
Glenview, Illinois 60025
?
mi
from
Glenview, IL
Click here to add this to my saved trials
Grand Rapids, Michigan 49501
?
mi
from
Grand Rapids, MI
Click here to add this to my saved trials
Guaynabo, 00968
?
mi
from
Guaynabo,
Click here to add this to my saved trials
Honolulu, Hawaii 96817
?
mi
from
Honolulu, HI
Click here to add this to my saved trials
Houston, Texas 77054
?
mi
from
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana 46208
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jackson, Mississippi 39216
?
mi
from
Jackson, MS
Click here to add this to my saved trials
Johnson City, Tennessee 37604
?
mi
from
Johnson City, TN
Click here to add this to my saved trials
?
mi
from
Leawood, KS
Click here to add this to my saved trials
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...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
Milwaukee, Wisconsin 53233
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55413
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Oradell, New Jersey 07649
?
mi
from
Oradell, NJ
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19123
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15220
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
Providence, Rhode Island 02908
?
mi
from
Providence, RI
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Rockford, Illinois 61107
?
mi
from
Rockford, IL
Click here to add this to my saved trials
Rockville, Maryland 20892
?
mi
from
Rockville, MD
Click here to add this to my saved trials
Rockville, Maryland 20852
?
mi
from
Rockville, MD
Click here to add this to my saved trials
10100 Doctor Martin Luther King Junior Street North
Saint Petersburg, Florida 33716
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas 78201
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
384 West Orange Show Road
San Bernardino, California 92408
?
mi
from
San Bernardino, CA
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Spokane, Washington 99201
?
mi
from
Spokane, WA
Click here to add this to my saved trials
Temple, Texas 76508
?
mi
from
Temple, TX
Click here to add this to my saved trials
Urbana, Illinois 61801
?
mi
from
Urbana, IL
Click here to add this to my saved trials
Washington, D.C., District of Columbia 20004
?
mi
from
Washington, D.C.,
Click here to add this to my saved trials
West Hartford, Connecticut 06110
?
mi
from
West Hartford, CT
Click here to add this to my saved trials
Worcester, Massachusetts 01655
?
mi
from
Worcester, MA
Click here to add this to my saved trials