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Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

Status: Recruiting
Phase: Phase 3
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT00785525 (View complete trial on
DFCI Protocol ID: 06-700


The purpose of the study is to: - Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from National Marrow Donor Program donors (NMDP) donors - Assess the safety among NMDP donors of filgrastim administration and PBSC leukapheresis - Assess the safety and efficacy of filgrastim-mobilized PBSC in unrelated donor hematopoietic stem cell transplant recipients - Determine the acceptability of stem cell donation by filgrastim stimulated apheresis in normal donors


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Thomas Spitzer, MD, Massachusetts General Hospital

Site-responsible Investigators:
Joseph Antin, MD, Dana-Farber Cancer Institute

Dana-Farber Cancer Institute: Margaret Coles, 617-632-4890,
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in NMDP Standards and the Donor Center Manual of Operations. Exclusion Criteria: - Pregnancy or uninterruptible breastfeeding. Pregnancy is an absolute contraindication under this protocol. Women who are breastfeeding must be willing and able to interrupt breastfeeding during the administration of filgrastim and for two days following the final dose. - Sensitivity to filgrastim or to E. coli-derived recombinant protein products. - History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable. - History of deep vein thrombosis or pulmonary embolism. - History of iritis or episcleritis. - Thrombocytopenia < 150 x 10(9)/L (< 150,000/µL) at baseline evaluation. - Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated. - Positive Hemoglobin-Solubility (e.g., SickleDex™ or equivalent) test. - Donors receiving experimental therapy or investigational agents.
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