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โ† Trials
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Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

RecruitingPhase 3Ages 18 Years - 60 YearsAllCenter for International Blood and Marrow Transplโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. PBSC donors must meet the same criteria as NMDP marrow donors. These criteria are set forth in the Donor Center Manual of Operations. 2. 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: 1. 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. 2. Sensitivity to filgrastim or to E. coli-derived recombinant protein products. 3. 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. 4. History of deep vein thrombosis or pulmonary embolism. 5. History of iritis or episcleritis. 6. Thrombocytopenia \< 150 x 10\^9/L (\< 150,000/uL) at baseline evaluation. 7. Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated. 8. Positive Hemoglobin-Solubility (e.g., SickleDex or equivalent) test. 9. Donors receiving experimental therapy or investigational agents. 10. Positive pregnancy test collected/reported prior to start of filgrastim.
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What it tests

  • Filgrastim
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Where

4 sites
Gift of Life Bone Marrow Foundation
Boca Raton, United States
C.W. Bill Young Marrow Donor Center
Rockville, United States
Be The Match
Minneapolis, United States
DKMS Americas
New York, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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