Filgrastim-Mobilized Stem Cells for Transplantation Using Unrelated Donors
NCT00785525 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60000
Last updated 2025-04-13
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
Conditions
- Healthy
Interventions
- DRUG
-
PBSC donors will receive 10 µg/kg of filgrastim subcutaneously each day of a five day mobilization schedule.
Sponsors & Collaborators
-
National Marrow Donor Program
collaborator OTHER -
Center for International Blood and Marrow Transplant Research
lead NETWORK
Principal Investigators
-
John P Miller, MD, PhD · National Marrow Donor Program
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 1997-02-28
- Primary Completion
- 2030-01-31
- Completion
- 2030-01-31
Countries
- United States
Study Locations
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