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Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry
Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization \[31 July 2009\] and 31 July 2014). The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database. The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.
Age
0 - 18 years
Sex
ALL
Healthy Volunteers
No
Start Date
July 1, 2009
Primary Completion Date
July 1, 2014
Completion Date
July 1, 2014
Last Updated
August 13, 2015
201
ACTUAL participants
Lead Sponsor
Genzyme, a Sanofi Company
Collaborators
NCT04065399
NCT03520647
Data Source & Attribution
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