Mozobil for Autologous Stem Cell Mobilization

Inclusion Criteria

• •Patients eligible and planned for an autologous haematopoietic stem cell transplantation.
• •1.1 Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
• •1.2 WBC count ≥2.5x109/L.
• •1.3 Absolute neutrophil count ≥1.5x109/L.
• •1.4 Platelet count ≥100x109/L
• •1.5 Adequate cardiac, renal, hepatic and pulmonary function sufficient to undergo apheresis and transplantation.
• •1.6 Previously, heavily pretreated lymphoma patients or patients suspected to have a poor bone marrow stem cell reserve for at least one of the following:
• •\>2 lines of chemotherapy.
• •Previous radiotherapy involving bone marrow
• •Prior therapy with specific stem cell toxic chemotherapeutic agents
• •Platelets count pre-mobilisation, ≤150.103 x mm3
• •Level of circulating CD34+ ≤ 20 cells/mcL prior to apheresis on the collection day
• •Patients \> 60 years of age
• •2.2 History of any acute or chronic leukemia (including myelodysplastic syndrome.
• •2.3 Prior allogeneic or autologous transplantation.
• •2.4 Inability to tolerate stem cell harvest.
• •2.5 Peripheral venous access not possible.
• •2.6 Pregnant or nursing women.
• •2.7 Positive serology for hepatitis B or C.
• •2.8 Acute infection (febrile, i.e. temperature \> 38C) within 24 hours prior to dosing or antibiotic therapy within 7 days prior to the first dose of GCSF.
• •2.9 HIV positive.
• •2.10 Left ventricular ejection fraction \< 50%.
• •2.11 DLCO \< 50%.
• •2.12 Splenectomised or splenic irradiation.
• •2.13 Psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study.
• •2.14 Treatment with other investigational drugs within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilisation phase.