Trials / Completed
CompletedNCT01362179
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 21,974 (actual)
- Sponsor
- Center for International Blood and Marrow Transplant Research · Network
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2010-10-01
- Primary completion
- 2020-09-30
- Completion
- 2020-10-15
- First posted
- 2011-05-30
- Last updated
- 2020-10-20
Locations
29 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT01362179. Inclusion in this directory is not an endorsement.