CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0501 (clinicaltrials.gov NCT No: NCT00943943)
Title:G-CSF and Plerixafor with Sorafenib for acute myelogenous leukemia with FLT3 mutations
Principal Investigator:Michael Andreeff
Treatment Agent:G-CSF; Plerixafor; Sorafenib
Study Status:Open
Study Description:The goal of this clinical research study is to learn the most tolerable dose of
Nexavarâ (sorafenib) when given in combination with Mobozilâ (plerixafor) and
Neupogenâ (filgrastim) to patients with AML. The safety of this combination
will also be studied.

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Disease Group:Leukemia
Phase of Study:Phase I
Treatment Agents:G-CSF
Plerixafor
Sorafenib
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:No hospitalization is required for this study unless there are patient
monitoring concerns.
Supported By:Bayer HealthCare Pharmaceuticals, Inc.
Food and Drug Administration (FDA)
Genzyme Corporation
Georgia Institute of Technology
National Cancer Institute (NCI)
Onyx Pharmaceuticals
Return Visit:Cycle 1 on day 1, 2, 3, 4, and 5; then weekly. Optional blood draws day 1 at 3
time points: hr 0, 5, and 12; and days 2, 4, and 14, and an optional extra
research bone marrow aspiration both before treatment starts and on day 14-17.
Home Care:If agreeing to the optional research, presence is required, after the baseline
visit, on days 1, 2, 4, and 14-17 for sample collections.


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Physician Name:Michael Andreeff
Dept:Leukemia
For Clinical Trial Enrollment:713-792-7260
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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