National Marrow Donor Program Long-Term Donor Follow-Up

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01362179

Acronym

LTDFU

Enrollment

21974

Registered

2011-05-30

Start date

2010-10-31

Completion date

2020-10-15

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematologic Neoplasms

Keywords

malignant myeloid hematologic disorders, filgrastim, long term incidence, donors who received and in those who did not receive filgrastim.

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Puerto Rico, United States

Outcome results