Abstract
AMD3100 is a drug capable of mobilizing peripheral blood stem cells (PBSCs) in donors and in cancer patients as a single agent or in combination with granulocyte–colony-stimulating factor (G-CSF). We initiated a phase II study of 11 refractory or relapsed non-Hodgkin's lymphoma (NHL) patients, receiving 16 μg/kg daily of G-CSF for 4 days followed by 240 μg/kg of AMD3100 given subcutaneously on a new schedule of 9–10 h before apheresis collection on day 5. Our aims were to assess the effect of AMD3100 on the mobilization of CD34+ cells, dendritic cells (DCs) and lymphoma cells. Administration of G-CSF and AMD3100 were continued daily until ≥2 × 106 CD34+ cells/kg were collected. Adequate collection of the target of CD34+ cells was achieved in all but 1 patient within 2 days, and 10/11 patients were transplanted within 2 months. All transplanted patients engrafted with a mean of 10 and 12 days for neutrophils and platelets, respectively. Addition of AMD3100 to G-CSF resulted with >2.5-fold increase in CD34+ cells/μl (p = 0.0001) and in a >2-fold increase in pDC1 and pDC2 cells/μl (p = 0.003). Adverse events related to AMD3100 were minimal. AMD3100 was generally safe and improved PBSC and DC cell mobilization with no apparent contamination of lymphoma cells.
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