CLINICAL TRIAL SUMMARY

MDACC Study No:2007-0147 (clinicaltrials.gov NCT No: NCT00801489)
Title:A Phase 2 Study of Fludarabine, cytarabine, Filgrastim and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia
Principal Investigator:Gautam Borthakur
Treatment Agent:ARA-C; Fludarabine; G-CSF; Idarubicin
Study Status:Open
Study Description:The goal of this clinical research study is to learn if idarubicin can be added
to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim)
without increasing the risk of side effects. This study will also look at
whether the addition of idarubicin will increase the long-term chances of
patients remaining disease free.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:ARA-C
Fludarabine
G-CSF
Idarubicin
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Patients will be admitted for the duration of induction chemotherapy. Patients
over the age of 50 years will be given the option of staying in the "protected
environment" for the approximately 4 weeks of induction to remission.
Supported By:N/A
Return Visit:Once a month for approximately 7 months
Home Care:Supportive care that includes blood transfusions, antibiotics or growth factors
including G-CSF as per protocol can be administered by local oncologist.
Patients can be instructed to self-administer G-CSF.


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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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