National Marrow Donor Program Long-Term Donor Follow-Up
LTDFU
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)
1 other identifier
observational
21,974
2 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Longer than P75 for all trials
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 26, 2011
CompletedFirst Posted
Study publicly available on registry
May 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2020
CompletedOctober 20, 2020
March 1, 2020
10 years
May 26, 2011
October 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of malignant myeloid hematologic disorders
To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.
Post HSCT donation
Study Arms (2)
unstimulated BM donors
Observational (non-interventional) study.
filgrastim-mobilized PBSC donors
Observational (non-interventional) study.
Eligibility Criteria
10,000 unstimulated BM donors and 20,000 filgrastim-mobilized PBSC donors
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
City of Hope
Duarte, California, 91010-3012, United States
National Marrow Donor Program Northern California & Northwest District
Oakland, California, 94612, United States
National Marrow Donor Program Southern California & Southwest District
Santa Ana, California, 92705, United States
Colorado Marrow Donor Program
Denver, Colorado, 80230-6918, United States
OneBlood
Fort Lauderdale, Florida, 33309, United States
Hawaii Bone Marrow Donor Registry
Honolulu, Hawaii, 96817-1651, United States
LifeSource
Glenview, Illinois, 60025-2498, United States
Rock River Valley Blood Center
Rockford, Illinois, 61107, United States
Indiana Blood Center
Indianapolis, Indiana, 46208-4437, United States
National Marrow Donor Program Southcentral District, Heart of America
Leawood, Kansas, 66206, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115-6013, United States
Michigan Blood
Grand Rapids, Michigan, 49503, United States
The HLA Registry
Oradell, New Jersey, 07649, United States
New York Blood Center
Brooklyn, New York, 11201, United States
DKMS Americas
New York, New York, 10016, United States
National Marrow Donor Program Southeast District
Charlotte, North Carolina, 28269, United States
National Marrow Donor Program Northcentral District
Cleveland, Ohio, 44131, United States
Oklahoma Blood Institute
Oklahoma City, Oklahoma, 73104-3251, United States
National Marrow Donor Program Northeast District
Philadelphia, Pennsylvania, 19123-3594, United States
Rhode Island Blood Center
Providence, Rhode Island, 02908-4811, United States
Blood Assurance, Inc.
Chattanooga, Tennessee, 37403-1207, United States
Cooperative Appalachian Marrow Program Medic Regional Blood Center
Knoxville, Tennessee, 37601, United States
Baylor Research Institute
Dallas, Texas, 75246-2029, United States
Cook Children's
El Paso, Texas, 79913, United States
Gulf Coast Regional Blood Center
Houston, Texas, 77054-1802, United States
South Texas Blood and Tissue Center
San Antonio, Texas, 78201-2023, United States
Scott & White Clinic
Temple, Texas, 76508-0001, United States
Community Blood Center, Inc.
Appleton, Wisconsin, 54914-9106, United States
National Marrow Donor Program at Puerto Rico
Guaynabo, PR, 00968-2710, Puerto Rico
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Miller, MD, PhD
National Marrow Donor Program
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2011
First Posted
May 30, 2011
Study Start
October 1, 2010
Primary Completion
September 30, 2020
Study Completion
October 15, 2020
Last Updated
October 20, 2020
Record last verified: 2020-03