Leukemia, Myeloid, Acute Clinical Trial
Official title:
Chemosensitization With Plerixafor Plus G-CSF in Relapsed or Refractory Acute Myeloid Leukemia
This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.
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 this study, we seek to maximize blockage of the SDF-1/CXCR4 axis through
the following:
1. Addition of G-CSF, which down regulates SDF-1 expression and acts synergistically with
plerixafor in stem cell mobilization
2. Intravenous instead of subcutaneous dosing of plerixafor to improve kinetics of
administration.
3. Dose escalation of plerixafor and twice daily dosing to maintain maximum CXCR4
blockade.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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