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| Name | Class |
|---|---|
| University Hospital Carl Gustav Carus | OTHER |
| Cellex Gesellschaft für Zellgewinnung mbH Dresden | UNKNOWN |
| Cellex Gesellschaft für Zellgewinnung mbH Köln | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plerixafor, Mozobil | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plerixafor | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Hölig, Dr. med. | Universitätsklinikum Carl Gustav Carus, Medizinische Klinik und Poliklinik I, 01307 Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cellex Gesellschaft für Zellgewinnung mbH Köln | Cologne | 50670 | Germany | |||
| Cellex Gesellschaft für Zellgewinnung mbH Dresden |
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| ID | Term |
|---|---|
| C088327 | plerixafor |
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|
| 30 days |
| Dresden |
| 01307 |
| Germany |
| Universitätsklinikum Dresden, Medizinische Klinik I | Dresden | 01307 | Germany |