drugset / Trial / NCT01954914
Plerixafor as a Salvage Regimen to Mobilize Allogeneic Stem Cells in Healthy Volunteers
Phase 2
Completed
39 enrolled
Technical University Dresden
Cellex Gesellschaft für Zellgewinnung mbH Dresden · collabCellex Gesellschaft für Zellgewinnung mbH Köln · collabUniversity Hospital Carl Gustav Carus · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-12
- Primary completion
- 2016-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Plerixafor | Small molecule | 240 ug/kg | Subcutaneous |