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)
18 Years
60 Years
Both
Hematologic Neoplasms
Trial Information
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. 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. Donation was managed by a U.S. NMDP donor center.
3. Signed informed consent for participation in this long-term donor follow-up study.
4. Concurrent enrollment on other studies is permitted (e.g. A Phase III Randomized
Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow
Transplantation from HLA Compatible Unrelated Donors (BMT CTN PvM Protocol 0201) and
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
(RDSafe).
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort
Principal Investigator
John P Miller, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Marrow Donor Program
Authority:
United States: Federal Government
Study ID:
LTDFU
NCT ID:
NCT01362179
Start Date:
October 2010
Completion Date:
October 2020
Related Keywords:
- Hematologic Neoplasms
- malignant myeloid hematologic disorders
- filgrastim
- long term incidence
- donors who received and in those who did not receive filgrastim.
- Neoplasms
- Hematologic Neoplasms
Name | Location |
|---|---|
| James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| New York Blood Center | New York, New York 10021 |
| City of Hope | Duarte, California 91010 |
| Baylor Research Institute | Dallas, Texas 75246 |
| The Johns Hopkins Hospital | Baltimore, Maryland 21205 |
| Puget Sound Blood Center | Seattle, Washington 98014 |
| Colorado Marrow Donor Program | Denver, Colorado 80230 |
| Hawaii Bone Marrow Donor Registry | Honolulu, Hawaii 96817 |
| LifeSource | Glenview, Illinois 60025 |
| Rock River Valley Blood Center | Rockford, Illinois 61107 |
| Indiana Blood Center | Indianapolis, Indiana 46208 |
| NIH Marrow Donor Center | Rockville, Maryland 20892 |
| The HLA Registry | Oradell, New Jersey 07649 |
| DKMS Americas | New York, New York 10016 |
| Rhode Island Blood Center | Providence, Rhode Island 02908 |
| Blood Assurance, Inc. | Chattanooga, Tennessee 37403 |
| Gulf Coast Regional Blood Center | Houston, Texas 77054 |
| South Texas Blood and Tissue Center | San Antonio, Texas 78201 |
| Scott & White Clinic | Temple, Texas 76508 |
| Community Blood Center, Inc. | Appleton, Wisconsin 54914 |
| National Marrow Donor Program Northern California & Northwest District | Oakland, California 94612 |
| National Marrow Donor Program Southern California & Southwest District | Santa Ana, California 92705 |
| Community Blood Centers of Florida, Inc. | Lauderhill, Florida 33313-5006 |
| National Marrow Donor Program Southcentral District, Heart of America | Leawood, Kansas 66206 |
| Michigan Blood | Grand Rapids, Michigan 49503 |
| National Marrow Donor Program Southeast District | Charlotte, North Carolina 28269 |
| National Marrow Donor Program Northcentral District | Cleveland, Ohio 44131 |
| Oklahoma Blood Institute | Oklahoma City, Oklahoma 73104-3251 |
| National Marrow Donor Program Northeast District | Philadelphia, Pennsylvania 19123-3594 |
| Cooperative Appalachian Marrow Program Medic Regional Blood Center | Knoxville, Tennessee 37601 |
| Cook Children's | El Paso, Texas 79913 |
