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


Phase 4
N/A
18 Years
Open (Enrolling by invite only)
Both
Acute Leukemia, Chronic Leukemia, Myelodysplastic Syndrome, Myeloproliferative Neoplasm, Solid Tumors, Lymphoma, Plasma Cell Disorders

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

European Union: European Medicines Agency

Study ID:

MOZ19310

NCT ID:

NCT01362985

Start Date:

September 2011

Completion Date:

July 2014

Related Keywords:

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

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