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Clinical Trial Summary

This study is designed to test the combination of Plerixafor with G-CSF for chemosensitization in patients with relapsed or refractory AML.


Clinical Trial Description

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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00906945
Study type Interventional
Source Washington University School of Medicine
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date February 2011
Completion date September 2015

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