National Marrow Donor Program Long-Term Donor Follow-Up

Center for International Blood and Marrow Transplant Research21,974 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

21,974

Conditions

Hematologic Neoplasms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (29)

Outcomes

Primary Outcomes

Incidence of malignant myeloid hematologic disorders

To describe the long-term incidence of malignant myeloid hematologic disorders in donors who received and in those who did not receive filgrastim.

Time frame: Post HSCT donation

Data from ClinicalTrials.gov

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City of Hope

Duarte, California, United States

National Marrow Donor Program Northern California & Northwest District

Oakland, California, United States

National Marrow Donor Program Southern California & Southwest District

Santa Ana, California, United States

Colorado Marrow Donor Program

Denver, Colorado, United States

OneBlood

Fort Lauderdale, Florida, United States

Hawaii Bone Marrow Donor Registry

Honolulu, Hawaii, United States

LifeSource

Glenview, Illinois, United States

Rock River Valley Blood Center

Rockford, Illinois, United States

Indiana Blood Center

Indianapolis, Indiana, United States

National Marrow Donor Program Southcentral District, Heart of America

Leawood, Kansas, United States

...and 19 more locations