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

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ClinicalTrials.gov Identifier: NCT01362179
Recruitment Status : Active, not recruiting
First Posted : May 30, 2011
Last Update Posted : June 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Hematologic Neoplasms

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.

Study Design

Study Type : Observational
Estimated Enrollment : 21932 participants
Observational Model: Cohort
Time Perspective: Other
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)
Study Start Date : October 2010
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
unstimulated BM donors
Observational (non-interventional) study.
filgrastim-mobilized PBSC donors
Observational (non-interventional) study.


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
10,000 unstimulated BM donors and 20,000 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362179


  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

Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT01362179     History of Changes
Other Study ID Numbers: LTDFU
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: October 2016

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