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

NCT01362985 | Completed

• 2 other identifiers: MOZ19310OBS13612
• Study Type: observational
• Target: 201
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

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

  5 years

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated off-label with plerixafor.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead
• European Society for Blood and Marrow Transplantation: collaborator

MeSH Terms

Conditions

Myelodysplastic Syndromes; Myeloproliferative Disorders; Lymphoma

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Medical Monitor

  Genzyme, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: July 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 13, 2015

Record last verified: 2015-08