With a standard mobilization regimen using G-CSF, approximately 5% of allogeneic donors does not mobilize enough CD34+ cells to reach an optimal dose for transplantation and are therefore called "poor mobilizers". A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is \> 4.5 x 106/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 106/kg body weight of the recipient.The objective of this trial is to assess the efficacy of a single dose of Plerixafor as salvage procedure in allogeneic stem cell donors with a poor CD34+ cell yield after the first day of peripheral blood stem cell collection.
In this trial the administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1 will be provided. The apheresis on day 2 is performed according to standard recommendations.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1.
Cellex Gesellschaft für Zellgewinnung mbH Köln
Cologne, Germany
Cellex Gesellschaft für Zellgewinnung mbH Dresden
Dresden, Germany
Universitätsklinikum Dresden, Medizinische Klinik I
Dresden, Germany
Rate of donation success
A generally accepted optimum CD34+ PBSC dose for allogeneic transplantation is \> 4.5 x 10e6/kg body weight of the recipient. The minimum total CD34+ PBSC dose certainly amounts to 2 x 10e6/kg body weight of the recipient.
Time frame: 1 day
Assessment of donor safety and tolerability based on self-reporting on a questionnaire, clinical findings, and laboratory evaluations; and evaluation of the cellular composition of the apheresis products collected with and without Plerixafor application.
The composition of apheresis products collected after filgrastim or filgrastim plus Plerixafor will be characterized with respect to: * CD34+ cell subsets (differential expression of prominin1/CD133+)33 * Regulatory T-cells34 * Dendritic cells * Myeloid-derived suppressor cells
Time frame: 30 days
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