RecruitingPhase 3

Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

United States60,000 participantsStarted 1997-02

Plain-language summary

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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations.
✓. Confirmatory pregnancy test must be performed within 15 days of collection and prior to the start of filgrastim administration; this may require more than one test to be performed.

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/uL) 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.

What they're measuring

Establish and evaluate a system for collection of filgrastim-mobilized peripheral blood stem cells from NMDP donors.

Timeframe: Ongoing

Trial details

NCT IDNCT00785525

SponsorCenter for International Blood and Marrow Transplant Research

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2030-01

Contact for this trial

Lisa Erickson

PBSCStudyTeam@nmdp.org

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