NCT01362985

Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor

Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 201 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Leukemia
• Chronic Leukemia
• Myelodysplastic Syndrome
• Myeloproliferative Neoplasm
• Solid Tumors
• Lymphoma
• Plasma Cell Disorders

Timeline

• Start date: 2009-07-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2011-06-01
• Last updated: 2015-08-13