National Marrow Donor Program Long-Term Donor Follow-Up
Status: Recruiting
Phase: N/A
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01362179
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 10-704
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.
Conducting Institutions:
Dana-Farber Cancer Institute
Overall PI:
Vincent Ho, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Contacts:
Eligibility Criteria
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. Donation was managed by a U.S. NMDP donor center.
3. Signed informed consent for participation in this long-term donor follow-up study.
4. Concurrent enrollment on other studies is permitted (e.g. A Phase III Randomized
Multicenter Trial Comparing G-CSF Mobilized Peripheral Blood Stem Cell with Marrow
Transplantation from HLA Compatible Unrelated Donors (BMT CTN PvM Protocol 0201) and
A Multicenter Study of Hematopoietic Stem Cell Donor Safety and Quality of Life
(RDSafe).
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.