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

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.

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Key information

Conditions

Acute Leukemia Bone Marrow Diseases Chronic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Myeloproliferative Disorders Myeloproliferative Neoplasm Neoplasms Neoplasms by Histologic Type Plasma Cell Disorders Solid Tumors

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration

Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Collaborators

European Society for Blood and Marrow Transplantation

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jun 1, 2011
Registry last updated: Aug 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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