National Marrow Donor Program Long-Term Donor Follow-Up

NCT ID: NCT01362179

Last Updated: 2020-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

21974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2020-10-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hematologic Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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unstimulated BM donors

Observational (non-interventional) study.

No interventions assigned to this group

filgrastim-mobilized PBSC donors

Observational (non-interventional) study.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Marrow Donor Program

OTHER

Sponsor Role collaborator

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John P Miller, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Marrow Donor Program

Locations

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City of Hope

Duarte, California, United States

Site Status

National Marrow Donor Program Northern California & Northwest District

Oakland, California, United States

Site Status

National Marrow Donor Program Southern California & Southwest District

Santa Ana, California, United States

Site Status

Colorado Marrow Donor Program

Denver, Colorado, United States

Site Status

OneBlood

Fort Lauderdale, Florida, United States

Site Status

Hawaii Bone Marrow Donor Registry

Honolulu, Hawaii, United States

Site Status

LifeSource

Glenview, Illinois, United States

Site Status

Rock River Valley Blood Center

Rockford, Illinois, United States

Site Status

Indiana Blood Center

Indianapolis, Indiana, United States

Site Status

National Marrow Donor Program Southcentral District, Heart of America

Leawood, Kansas, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Michigan Blood

Grand Rapids, Michigan, United States

Site Status

The HLA Registry

Oradell, New Jersey, United States

Site Status

New York Blood Center

Brooklyn, New York, United States

Site Status

DKMS Americas

New York, New York, United States

Site Status

National Marrow Donor Program Southeast District

Charlotte, North Carolina, United States

Site Status

National Marrow Donor Program Northcentral District

Cleveland, Ohio, United States

Site Status

Oklahoma Blood Institute

Oklahoma City, Oklahoma, United States

Site Status

National Marrow Donor Program Northeast District

Philadelphia, Pennsylvania, United States

Site Status

Rhode Island Blood Center

Providence, Rhode Island, United States

Site Status

Blood Assurance, Inc.

Chattanooga, Tennessee, United States

Site Status

Cooperative Appalachian Marrow Program Medic Regional Blood Center

Knoxville, Tennessee, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

Cook Children's

El Paso, Texas, United States

Site Status

Gulf Coast Regional Blood Center

Houston, Texas, United States

Site Status

South Texas Blood and Tissue Center

San Antonio, Texas, United States

Site Status

Scott & White Clinic

Temple, Texas, United States

Site Status

Community Blood Center, Inc.

Appleton, Wisconsin, United States

Site Status

National Marrow Donor Program at Puerto Rico

Guaynabo, PR, Puerto Rico

Site Status

Countries

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United States Puerto Rico

Other Identifiers

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LTDFU

Identifier Type: -

Identifier Source: org_study_id

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