CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0288 (clinicaltrials.gov NCT No: NCT00882102)
Title:Phase II Study of Decitabine and Gemtuzumab Ozogamicin in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome
Principal Investigator:Gautam Borthakur
Treatment Agent:Decitabine; Gemtuzamab Ozogamicin
Study Status:Terminated
Study Description:The goal of this clinical research study is to learn if 5-aza-2 deoxycytidine
(decitabine) given in combination with Mylotarg (gemtuzumab ozogamicin) can
help to control AML, high-risk MDS or MF. The safety of this drug combination
will also be studied.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:Decitabine
Gemtuzamab Ozogamicin
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Since the treatment can be administered as out-patient we do not expect
hospitalization unless required for other reasons
Supported By:Eisai, Inc.
Return Visit:1-3 months
Home Care:Post induction cycles as well as supportive care can be administered at a local
oncologists office.


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Physician Name:Gautam Borthakur
Dept:Leukemia
For Clinical Trial Enrollment:713-563-1586
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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