National Marrow Donor Program Long-Term Donor Follow-Up

Completed

• Conditions: Hematologic Neoplasms

• Registration Number: NCT01362179
• Lead Sponsor: Center for International Blood and Marrow Transplant Research

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.

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 Timeline

• Study Start: 2010-10
• Study First Submitted: 2011-05-26
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Status Verified: 2020-03
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-15
• Last Update Submitted: 2020-10-19
• Last Update Posted: 2020-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21974

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of malignant myeloid hematologic disorders	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.

Trial Locations

Locations (29)

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

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