National Marrow Donor Program Long-Term Donor Follow-Up (LTDFU)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Center for International Blood and Marrow Transplant Research
Sponsor:
Collaborator:
National Marrow Donor Program
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier:
NCT01362179
First received: May 26, 2011
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

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.


Condition
Hematologic Neoplasms

Study Type: Observational
Study Design: Observational Model: Cohort
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)

Resource links provided by NLM:


Further study details as provided by Center for International Blood and Marrow Transplant Research:

Primary Outcome Measures:
  • Incidence of malignant myeloid hematologic disorders [ Time Frame: Post HSCT donation ] [ Designated as safety issue: No ]
    To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.


Estimated Enrollment: 32000
Study Start Date: October 2010
Estimated Study Completion Date: October 2020
Estimated Primary Completion Date: October 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts
unstimulated BM donors
Observational (non-interventional) study.
filgrastim-mobilized PBSC donors
Observational (non-interventional) study.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

10,956 unstimulated BM donors and 21,172 filgrastim-mobilized PBSC donors

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362179

Contacts
Contact: Susan Flesch 612-617-8303 sflesch@nmdp.org

  Hide Study Locations
Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010-3012
National Marrow Donor Program Northern California & Northwest District Recruiting
Oakland, California, United States, 94612
National Marrow Donor Program Southern California & Southwest District Recruiting
Santa Ana, California, United States, 92705
United States, Colorado
Colorado Marrow Donor Program Recruiting
Denver, Colorado, United States, 80230-6918
United States, Florida
Community Blood Centers of Florida, Inc. Recruiting
Lauderhill, Florida, United States, 33313-5006
United States, Hawaii
Hawaii Bone Marrow Donor Registry Recruiting
Honolulu, Hawaii, United States, 96817-1651
United States, Illinois
LifeSource Recruiting
Glenview, Illinois, United States, 60025-2498
Rock River Valley Blood Center Recruiting
Rockford, Illinois, United States, 61107
United States, Indiana
Indiana Blood Center Recruiting
Indianapolis, Indiana, United States, 46208-4437
United States, Kansas
National Marrow Donor Program Southcentral District, Heart of America Recruiting
Leawood, Kansas, United States, 66206
United States, Maryland
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21205-2020
NIH Marrow Donor Center Recruiting
Rockville, Maryland, United States, 20852-3839
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115-6013
United States, Michigan
Michigan Blood Recruiting
Grand Rapids, Michigan, United States, 49503
United States, New Jersey
The HLA Registry Recruiting
Oradell, New Jersey, United States, 07649
United States, New York
New York Blood Center Recruiting
Brooklyn, New York, United States, 11201
DKMS Americas Recruiting
New York, New York, United States, 10016
United States, North Carolina
National Marrow Donor Program Southeast District Recruiting
Charlotte, North Carolina, United States, 28269
United States, Ohio
National Marrow Donor Program Northcentral District Recruiting
Cleveland, Ohio, United States, 44131
United States, Oklahoma
Oklahoma Blood Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104-3251
United States, Pennsylvania
National Marrow Donor Program Northeast District Recruiting
Philadelphia, Pennsylvania, United States, 19123-3594
United States, Rhode Island
Rhode Island Blood Center Recruiting
Providence, Rhode Island, United States, 02908-4811
United States, Tennessee
Blood Assurance, Inc. Recruiting
Chattanooga, Tennessee, United States, 37403-1207
Cooperative Appalachian Marrow Program Medic Regional Blood Center Recruiting
Knoxville, Tennessee, United States, 37601
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246-2029
Cook Children's Recruiting
El Paso, Texas, United States, 79913
Gulf Coast Regional Blood Center Recruiting
Houston, Texas, United States, 77054-1802
South Texas Blood and Tissue Center Recruiting
San Antonio, Texas, United States, 78201-2023
Scott & White Clinic Recruiting
Temple, Texas, United States, 76508-0001
United States, Washington
Puget Sound Blood Center Recruiting
Seattle, Washington, United States, 98104-1239
United States, Wisconsin
Community Blood Center, Inc. Recruiting
Appleton, Wisconsin, United States, 54914-9106
Puerto Rico
National Marrow Donor Program at Puerto Rico Recruiting
Guaynabo, Puerto Rico, 00968-2710
Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Investigators
Principal Investigator: John P Miller, MD, PhD National Marrow Donor Program
  More Information

No publications provided

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01362179     History of Changes
Other Study ID Numbers: LTDFU
Study First Received: May 26, 2011
Last Updated: April 3, 2014
Health Authority: United States: Federal Government

Keywords provided by Center for International Blood and Marrow Transplant Research:
malignant myeloid hematologic disorders
filgrastim
long term incidence
donors who received and in those who did not receive filgrastim.

Additional relevant MeSH terms:
Hematologic Neoplasms
Hematologic Diseases
Neoplasms
Neoplasms by Site
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014