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

This study is currently recruiting participants.

Verified September 2012 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: September 25, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

May 26, 2011

Last Updated Date

September 25, 2012

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2020 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01362179 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

National Marrow Donor Program Long-Term Donor Follow-Up

Official Title ^ICMJE

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)

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. 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.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Hematologic Neoplasms

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

unstimulated BM donors
filgrastim-mobilized PBSC donors

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

32000

Estimated Completion Date

October 2020

Estimated Primary Completion Date

October 2020 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Unrelated donor who donated either unstimulated BM or 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 (e.g. A Phase III Randomized Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow Transplantation from HLA Compatible Unrelated Donors (BMT CTN PvM Protocol 0201) and A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life (RDSafe).

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.

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Susan Flesch

612-617-8303

sflesch@nmdp.org

Location Countries ^ICMJE

United States, Puerto Rico

Administrative Information

NCT Number ^ICMJE

NCT01362179

Other Study ID Numbers ^ICMJE

LTDFU

Has Data Monitoring Committee

Yes

Responsible Party

Center for International Blood and Marrow Transplant Research

Study Sponsor ^ICMJE

Center for International Blood and Marrow Transplant Research

Collaborators ^ICMJE

National Marrow Donor Program

Investigators ^ICMJE

Principal Investigator:

John P Miller, MD, PhD

National Marrow Donor Program

Information Provided By

Center for International Blood and Marrow Transplant Research

Verification Date

September 2012

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

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