Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
Phase: Phase 3
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT00785525
(View complete trial on ClinicalTrials.gov)
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
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Thomas Spitzer, MD,
Massachusetts General Hospital
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
- 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.
- 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
- 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.