Filgrastim-Mobilized Peripheral Blood Stem Cells for Allogeneic Transplantation with Unrelated Donors

Trial ID:
IRB-13-6170
James Mason
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

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.

Contact Info:

  • Deborah Mattila
  • dmattila@nmdp.org
  • 612-884-8707