CLINICAL TRIAL SUMMARY

MDACC Study No:2009-0536 (clinicaltrials.gov NCT No: NCT01160354)
Title:Phase I/II Study of Plerixafor and Clofarabine in Previously Untreated Older (>/=60 years) Adult Patients with Acute Myelogenous Leukemia (AML) with two or more unfavorable prognostic factors for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
Principal Investigator:Jan A. Burger
Treatment Agent:Clofarabine; Plerixafor
Study Status:Closed
Study Description:The goal of Part 1 of this clinical research study is to learn about the safety
of the combination of plerixafor and clofarabine when given to patients with
previously untreated AML who are at least 60 years old.

The goal of Part 2 of this study is to learn if the combination of plerixafor
and clofarabine can help to control previously untreated AML in patients who
are at least 60 years old.

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Disease Group:Leukemia
Phase of Study:Phase I/Phase II
Treatment Agents:Clofarabine
Plerixafor
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Patients are required to stay in the Houston area for at least 4 weeks during
course 1. Longer stay may be required as judged by the treating physician.
There is a maximum of 6 cycles over approximately 5 months.
Supported By:Genzyme Corporation
Return Visit:Outpatient visits at least weekly until CR, non-response, or resolution of
toxicities. Return to MDACC thereafter every 3-6 months during the first year
and then every 6-12 months as long as on study.
Home Care:As required.


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Physician Name:Jan A. Burger
Dept:Leukemia
For Clinical Trial Enrollment:713-792-1865
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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