At a glance
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Plerixafor for Stem Cell Mobilization in Normal Donors
In Brief
A Phase 2 clinical trial evaluating Filgrastim, Plerixafor, and 1 other intervention for Blood And Marrow Transplantation. Completed, enrolled 22 participants across 1 site.
Detailed Summary
The goal of this clinical research study is to learn if treating stem cell donors with filgrastim (G-CSF) and plerixafor (Mozobil®) can cause them to produce a higher number of blood stem cells than filgrastim by itself. Researchers also want to learn if giving both of these drugs helps donors produce enough stem cells so that only 1 apheresis procedure needs to be performed. Researchers will study if using both drugs lowers the risk of the stem cell transplant recipients developing severe forms graft-versus-host disease (GVHD). GVHD is a condition in which transplanted tissue (such as blood stem cells) attacks the tissue of the recipient's body. The safety and effectiveness of this drug combination will also be studied. Filgrastim and plerixafor are both designed to help move or "mobilize" the stem cells from the bone marrow to the blood.
Study Details
Timeline
Interventions
5 µg/kg in the morning daily for 4 days.
240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.
The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor. The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained.