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

NCT ID: NCT01362985

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 201 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2014-07-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT

Eligibility Criteria

Inclusion Criteria

• 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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Society for Blood and Marrow Transplantation

NETWORK

Sponsor Role: collaborator

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Genzyme, a Sanofi Company

Other Identifiers

OBS13612

Identifier Type: OTHER

Identifier Source: secondary_id

MOZ19310

Identifier Type: -

Identifier Source: org_study_id