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Completed

NCT Number: NCT01362179

National Marrow Donor Program Long-Term Donor Follow-Up

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Marrow Donor Program at Puerto Rico, Guaynabo, PR, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of malignant myeloid hematologic disorders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Center for International Blood and Marrow Transplant Research

Network

Collaborators

  • National Marrow Donor Program

Registry information

Official study 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)

Acronym: LTDFU

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
May 30, 2011
Registry last updated
Oct 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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