Plerixafor (Plerixafor AMD 3100) + Recombinant Human G-CSF (rhG-CSF) for Autologous Peripheral Blood Stem Cell Transplantation (AutoSCT) in Hard to Mobilise Patients: a Phase IIB Study
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
2.1 Lymphoma patients that did not fulfil the inclusion criteria.
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