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Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors

StatusRecruiting
PhasePhase 3
Started1997-02
View on ClinicalTrials.gov ↗

Amendment history

2025-04-09
Study Status, Oversight, Contacts/Locations v30
Study sitescontacts updated at 1 of 4 sites
2025-01-29
2 amendments v28-v29
2 re-verifications since 2025-01-23, no change to tracked fields
2023-07-21
Study Status, Study Design, Contacts/Locations v27
Enrollment target40000→60000
Study sites20→4
2022-03-07
Study Status v26
Primary completion date2022-01→2030-01
Completion date2022-01→2030-01
2021-03-11
Study Status, Eligibility, Contacts/Locations v25
Study sites55→20
Eligibility criteria+233 characters
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. 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 breastfeedi [...] story of iritis or episcleritis. Thrombocytopenia < 150 x 10(^9)/L (< 150,000/µLuL) at baseline evaluation. Current treatment with lithium. Dr [...] y evaluated. Positive Hemoglobin-Solubility [...]
Show 24 earlier versions
2019-06-18
Study Status v24
Re-verified, no change to tracked fields
2017-06-13
Study Status, Study Design, Contacts/Locations v23
Enrollment target35000→40000
Study sitesdetails revised at 1 of 55 sites
2017-02-15
Study Status, Study Design v22
Primary completion date2017-01→2022-01
2016-10-24
Study Status v21
Re-verified, no change to tracked fields
2016-01-26
Study Status, Study Design v20
Enrollment target20000→35000
2015-07-27
12 amendments v8-v19
12 re-verifications since 2013-03-30, no change to tracked fields
2013-03-24
Study Status, Study Design, Contacts/Locations v7
Enrollment target15000→20000
2012-09-25
Study Status, Contacts/Locations v6
Re-verified, no change to tracked fields
2012-02-14
Study Status, Sponsor/Collaborators, Contacts/Locations v5
Primary completion date2012-01→2017-01
Completion date2015-01→2022-01
Collaborators+29 characters
National Marrow Donor Program
2011-09-14
2 amendments v3-v4
2 re-verifications since 2011-03-17, no change to tracked fields
2009-04-30
Study Status, Study Design, Contacts/Locations, References v2
Enrollment target10000→15000
2008-11-12
Study Status, References v1
Re-verified, no change to tracked fields
2008-11-04
Original filing
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
Trial Details
NCT Number NCT00785525
Lead Sponsor Center for International Blood and Marrow Transplant Research
Collaborators: National Marrow Donor Program
Conditions Healthy
Enrollment 60,000 participants
Start Date 1997-02
Primary Completion 2030-01 (estimated)
Study Completion 2030-01 (estimated)
Updated on ClinicalTrials.gov 2025-04-13