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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362985
• Other study ID #: MOZ19310
• Secondary ID: OBS13612
• Status: Completed
• Phase: Phase 4
• First received: May 27, 2011
• Last updated: August 12, 2015
• Start date: July 2009
• Est. completion date: July 2014

Study information

• Verified date: August 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria: Patients treated with plerixafor who have 1 or more of the following:

• Background disease other than lymphoma or multiple myeloma (MM)

• Are younger than 18 years of age.

• Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection)

• Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF))

• Contraindication for G-CSF

• Transplants using plerixafor-mobilised cells from allogeneic donor

• Received transplant using plerixafor-mobilised bone marrow cells

• Routes of plerixafor administration other than subcutaneous

• Patients whose cells do not mobilize poorly

• Other

Exclusion Criteria:

• Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company	European Group for Blood and Marrow Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration		5 years	No