NCT00785525 Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
| NCT ID | NCT00785525 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Center for International Blood and Marrow Transplant Research |
| Condition | Healthy |
| Study Type | INTERVENTIONAL |
| Enrollment | 60,000 participants |
| Start Date | 1997-02 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60,000 participants in total. It began in 1997-02 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Eligibility Criteria
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.
Contact & Investigator
Lisa Erickson
✉ PBSCStudyTeam@nmdp.orgJohn P Miller, MD, PhD
PRINCIPAL INVESTIGATOR
National Marrow Donor Program
Frequently Asked Questions
Who can join the NCT00785525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Healthy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT00785525 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60,000 participants.
Is NCT00785525 currently recruiting?
Yes, NCT00785525 is actively recruiting participants. Contact the research team at PBSCStudyTeam@nmdp.org for enrollment information.
Where is the NCT00785525 trial being conducted?
This trial is being conducted at Boca Raton, United States, Rockville, United States, Minneapolis, United States, New York, United States.
Who is sponsoring the NCT00785525 clinical trial?
NCT00785525 is sponsored by Center for International Blood and Marrow Transplant Research. The principal investigator is John P Miller, MD, PhD at National Marrow Donor Program. The trial plans to enroll 60,000 participants.