National Marrow Donor Program Long-Term Donor Follow-Up
- Conditions
- Hematologic Neoplasms
- Registration Number
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 21974
- Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation.
- 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.
- Donation was managed by a U.S. NMDP donor center.
- Signed informed consent for participation in this long-term donor follow-up study. Concurrent enrollment on other studies is permitted.
- Unrelated donor who donated filgrastim-mobilized bone marrow.
- Donation was managed by a non-U.S. donor center.
- Donor is unable to verbally communicate in any of the following languages: English, Spanish, Mandarin Chinese, Cantonese Chinese, Vietnamese, Korean, or Portuguese.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of malignant myeloid hematologic disorders Post HSCT donation To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
National Marrow Donor Program Northeast District
🇺🇸Philadelphia, Pennsylvania, United States
Baylor Research Institute
🇺🇸Dallas, Texas, United States
National Marrow Donor Program Southcentral District, Heart of America
🇺🇸Leawood, Kansas, United States
Hawaii Bone Marrow Donor Registry
🇺🇸Honolulu, Hawaii, United States
Indiana Blood Center
🇺🇸Indianapolis, Indiana, United States
Oklahoma Blood Institute
🇺🇸Oklahoma City, Oklahoma, United States
South Texas Blood and Tissue Center
🇺🇸San Antonio, Texas, United States
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
LifeSource
🇺🇸Glenview, Illinois, United States
Rock River Valley Blood Center
🇺🇸Rockford, Illinois, United States
New York Blood Center
🇺🇸Brooklyn, New York, United States
Michigan Blood
🇺🇸Grand Rapids, Michigan, 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
Rhode Island Blood Center
🇺🇸Providence, Rhode Island, United States
Gulf Coast Regional Blood Center
🇺🇸Houston, Texas, United States
Community Blood Center, Inc.
🇺🇸Appleton, Wisconsin, United States
Cook Children's
🇺🇸El Paso, Texas, United States
The HLA Registry
🇺🇸Oradell, New Jersey, United States
Blood Assurance, Inc.
🇺🇸Chattanooga, Tennessee, United States
Cooperative Appalachian Marrow Program Medic Regional Blood Center
🇺🇸Knoxville, Tennessee, United States
Scott & White Clinic
🇺🇸Temple, Texas, United States
National Marrow Donor Program at Puerto Rico
🇵🇷Guaynabo, Puerto Rico