Myelodysplastic Syndromes Clinical Trial
Official title:
A Phase I Trial Evaluating the Effects of Plerixafor (AMD3100) and G-CSF in Combination With Azacitidine (Vidaza) for the Treatment of MDS
Our main objectives are to determine the optimal dose and schedule of plerixafor + G-CSF and azacitidine in patients with MDS and determine the safety and tolerability of plerixafor + G-CSF and azacitidine.
The interaction of normal stem cells with the bone marrow microenvironment is mediated by a number of factors. These interactions have been implicated in protecting malignant hematopoietic cells from spontaneous apoptosis and genotoxic stresses such as chemotherapy. Key elements are CXCR4, which is expressed on normal stem cells and leukemic blasts, and its ligand, stromal derived factor 1 (SDF-1) expressed by bone marrow stromal cells and osteoblasts. The CXCR4/SDF-1 axis is essential for homing, retention and mobilization of stem cells from the bone marrow microenvironment. Plerixafor is a bicyclam small molecule inhibitor of CXCR4 and has been extensively studied by our group and others as a potent stem cell mobilization agent both in combination with G-CSF or alone (25, 62). Plerixafor is currently being investigated in a phase I/II trial in combination with salvage chemotherapy for relapsed AML in an attempt to sensitize leukemia stem cells to chemotherapy. The goal of this study is to determine the optimal dose of plerixafor for the treatment of patients with high-risk myelodysplastic syndrome (MDS) in combination with G-CSF and azacitidine. We hypothesize that plerixafor in combination with G-CSF will detach MDS blasts from the bone marrow microenvironment resulting in their increased proliferation and sensitivity to azacitidine; thus, improving complete and partial response rates (CR/PR). ;
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