Chemosensitization With Plerixafor Plus G-CSF in 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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: To determine the maximum tolerated dose of plerixafor plus G-CSF when combined with MEC in patients with relapsed or refractory AML
45 days after start of treatment
Yes
Geoffrey L. Uy, M.D.
Principal Investigator
Washington University School of Medicine
United States: Institutional Review Board
10-0910 / 201106039
NCT00906945
February 2011
June 2016
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
Dana Farber Cancer Institute | Boston, Massachusetts 02115 |
Washington University | St. Louis, Missouri 63110 |