National Marrow Donor Program Long-Term Donor Follow-Up



Status:Active, not recruiting
Conditions:Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 60
Updated:8/25/2018
Start Date:October 2010
End Date:September 30, 2020

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Incidence of Hematologic and Non-Hematologic Malignancies, Thrombotic Events, and Autoimmune Disorders in Unrelated Normal Donors Undergoing Bone Marrow Harvest Versus Peripheral Blood Stem Cell Mobilization With Recombinant Human Granulocyte Colony-Stimulating Factor (rHuG-CSF)

This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized
peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that
the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated
hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized
PBSC donors.

This is an observational study of unstimulated bone marrow (BM) and filgrastim-mobilized
peripheral blood stem cell (PBSC) donors. The primary goal is to evaluate the hypothesis that
the incidence of targeted malignant, thrombotic and autoimmune disorders after unrelated
hematopoietic stem cell donation are similar between unstimulated BM and filgrastim-mobilized
PBSC donors. Donors will undergo biennial surveys until study completion. Cases of targeted
disorders will be reviewed by the medical monitors to confirm the veracity of the report.

Inclusion Criteria:

1. Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC
between July 1, 1999 and approximately five years post study activation.

2. Unrelated donor who received at least one injection of filgrastim or more, but did not
donate filgrastim-mobilized PBSC between July 1, 1999 and approximately five years
post study activation.

3. Donation was managed by a U.S. NMDP donor center.

4. Signed informed consent for participation in this long-term donor follow-up study.
Concurrent enrollment on other studies is permitted.

Exclusion Criteria:

1. Unrelated donor who donated filgrastim-mobilized bone marrow.

2. Donation was managed by a non-U.S. donor center.

3. Donor is unable to verbally communicate in any of the following languages: English,
Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.
We found this trial at
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Honolulu, Hawaii 96817
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Appleton, Wisconsin 54914
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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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, OH
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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Denver, Colorado 80230
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Duarte, California 91010
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El Paso, Texas 79913
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Fort Lauderdale, Florida 33309
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Glenview, Illinois 60025
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Grand Rapids, Michigan 49503
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Guaynabo,
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Houston, Texas 77054
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Indianapolis, Indiana 46208
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New York, New York 10016
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Oklahoma City, Oklahoma 73104
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Oradell, New Jersey 07649
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Philadelphia, Pennsylvania 19123
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Providence, Rhode Island 02908
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Rockford, Illinois 61107
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San Antonio, Texas 78201
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Temple, Texas 76508
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