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

May 26, 2011
April 3, 2014
October 2010
October 2020   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01362179 on ClinicalTrials.gov Archive Site
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National Marrow Donor Program Long-Term Donor Follow-Up
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.

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.

Observational
Observational Model: Cohort
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Non-Probability Sample

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

Hematologic Neoplasms
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  • unstimulated BM donors
    Observational (non-interventional) study.
  • filgrastim-mobilized PBSC donors
    Observational (non-interventional) study.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
32000
October 2020
October 2020   (final data collection date for primary outcome measure)

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.
Both
18 Years to 60 Years
No
Contact: Susan Flesch 612-617-8303 sflesch@nmdp.org
United States,   Puerto Rico
 
NCT01362179
LTDFU
Yes
Center for International Blood and Marrow Transplant Research
Center for International Blood and Marrow Transplant Research
National Marrow Donor Program
Principal Investigator: John P Miller, MD, PhD National Marrow Donor Program
Center for International Blood and Marrow Transplant Research
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP