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

  Show 32 Study Locations
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
Neoplasms by Site
Neoplasms
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014