Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor
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|ClinicalTrials.gov Identifier: NCT01362985|
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : August 13, 2015
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.
|Condition or disease|
|Acute Leukemia Chronic Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm Solid Tumors Lymphoma Plasma Cell Disorders|
|Study Type :||Observational|
|Actual Enrollment :||201 participants|
|Official Title:||Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry|
|Study Start Date :||July 2009|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
- Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration [ Time Frame: 5 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362985
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|