Status:
RECRUITING
Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
Lead Sponsor:
Center for International Blood and Marrow Transplant Research
Collaborating Sponsors:
National Marrow Donor Program
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 t...
Detailed Description
For many years, allogeneic bone marrow transplantation has been used to successfully treat leukemias, other hematologic conditions and congenital disorders. The first unrelated donor transplants were ...
Eligibility Criteria
Inclusion
- 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
- 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.
- Donors receiving experimental therapy or investigational agents.
- Positive pregnancy test collected/reported prior to start of filgrastim.
Key Trial Info
Start Date :
February 1 1997
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2030
Estimated Enrollment :
60000 Patients enrolled
Trial Details
Trial ID
NCT00785525
Start Date
February 1 1997
End Date
January 1 2030
Last Update
April 13 2025
Active Locations (4)
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1
Gift of Life Bone Marrow Foundation
Boca Raton, Florida, United States, 33431
2
C.W. Bill Young Marrow Donor Center
Rockville, Maryland, United States, 20852
3
Be The Match
Minneapolis, Minnesota, United States, 55401
4
DKMS Americas
New York, New York, United States, 10016