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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
Sponsor:
Collaborator:
European Group for Blood and Marrow Transplantation
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Brief 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.


Condition or disease
Acute Leukemia Chronic Leukemia Myelodysplastic Syndrome Myeloproliferative Neoplasm Solid Tumors Lymphoma Plasma Cell Disorders

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Study Type : Observational
Actual Enrollment : 201 participants
Observational Model: Cohort
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





Primary Outcome Measures :
  1. Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients treated off-label with plerixafor.
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Genzyme, a Sanofi Company
European Group for Blood and Marrow Transplantation
Investigators
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Study Director: Medical Monitor Genzyme, a Sanofi Company
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01362985    
Other Study ID Numbers: MOZ19310
OBS13612 ( Other Identifier: Sanofi )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Leukemia
Myelodysplastic Syndromes
Myeloproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases