National Marrow Donor Program Long-Term Donor Follow-Up

Study Overview
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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.

Official Title
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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)

Conditions
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Hematologic Neoplasms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unrelated donor who donated either unstimulated BM or filgrastim-mobilized PBSC between July 1, 1999 and approximately five years post study activation. 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. 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| unstimulated BM donors<br>Observational (non-interventional) study. | |
| filgrastim-mobilized PBSC donors<br>Observational (non-interventional) study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Post HSCT donation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant myeloid hematologic disorders, filgrastim, long term incidence, donors who received and in those who did not receive filgrastim.