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Brief Title: National Marrow Donor Program Long-Term Donor Follow-Up
Official Title: 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)
Study ID: NCT01362179
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: No
City of Hope, Duarte, California, United States
National Marrow Donor Program Northern California & Northwest District, Oakland, California, United States
National Marrow Donor Program Southern California & Southwest District, Santa Ana, California, United States
Colorado Marrow Donor Program, Denver, Colorado, United States
OneBlood, Fort Lauderdale, Florida, United States
Hawaii Bone Marrow Donor Registry, Honolulu, Hawaii, United States
LifeSource, Glenview, Illinois, United States
Rock River Valley Blood Center, Rockford, Illinois, United States
Indiana Blood Center, Indianapolis, Indiana, United States
National Marrow Donor Program Southcentral District, Heart of America, Leawood, Kansas, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Michigan Blood, Grand Rapids, Michigan, United States
The HLA Registry, Oradell, New Jersey, United States
New York Blood Center, Brooklyn, New York, United States
DKMS Americas, New York, New York, United States
National Marrow Donor Program Southeast District, Charlotte, North Carolina, United States
National Marrow Donor Program Northcentral District, Cleveland, Ohio, United States
Oklahoma Blood Institute, Oklahoma City, Oklahoma, United States
National Marrow Donor Program Northeast District, Philadelphia, Pennsylvania, United States
Rhode Island Blood Center, Providence, Rhode Island, United States
Blood Assurance, Inc., Chattanooga, Tennessee, United States
Cooperative Appalachian Marrow Program Medic Regional Blood Center, Knoxville, Tennessee, United States
Baylor Research Institute, Dallas, Texas, United States
Cook Children's, El Paso, Texas, United States
Gulf Coast Regional Blood Center, Houston, Texas, United States
South Texas Blood and Tissue Center, San Antonio, Texas, United States
Scott & White Clinic, Temple, Texas, United States
Community Blood Center, Inc., Appleton, Wisconsin, United States
National Marrow Donor Program at Puerto Rico, Guaynabo, , Puerto Rico
Name: John P Miller, MD, PhD
Affiliation: National Marrow Donor Program
Role: PRINCIPAL_INVESTIGATOR