A Phase I Study of Intravenous Plerixafor in Combination With Mitoxantrone Etoposide and Cytarabine for Relapsed or Refractory Acute Myeloid Leukemia
In this study, we are seeking to target the leukemia microenvironment to overcome disease
resistance. We hypothesize that by disrupting the interaction of leukemic blasts with the
bone marrow microenvironment, we may sensitize leukemic blasts to the effects of cytotoxic
chemotherapy. In current formulations, the volume of plerixafor required to administer
doses higher than 240 mcg/kg may result in significant discomfort with repeated daily
injections. In this phase I extension study, we seek to test the safety of both higher
doses of plerixafor as well as intravenous dosing to maximize inhibition of the target,
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the maximum tolerated dose and dose limiting toxicities of intravenous plerixafor when combined with MEC in patients with relapsed or refractory AML.
Geoffrey Uy, M.D.
Washington University School of Medicine
United States: Food and Drug Administration
09-1825 / 201101703
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