CLINICAL TRIAL SUMMARY

MDACC Study No:2008-0431 (clinicaltrials.gov NCT No: NCT00759798)
Title:Prospective Identification of Significant Prognostic Factors in Patients Treated with Fludarabine, Cyclophosphamide, and Rituximab (FCR) as Initial Therapy for Chronic Lymphocytic Leukemia.
Principal Investigator:William G. Wierda
Treatment Agent:Acetaminophen; Allopurinol; Cyclophosphamide; Fludarabine; Ondansetron Hydrochloride; Rituximab; Valacyclovir
Study Status:Open
Study Description:The goal of this clinical research study is to learn more about the
characteristics of CLL, including genes and chromosome abnormalities and
proteins expressed by the leukemia cells, which may help doctors predict if
patients who receive standard treatment (fludarabine, cyclophosphamide, and
rituximab) for the first time will experience a complete remission.

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Disease Group:Leukemia
Phase of Study:Phase II
Treatment Agents:Acetaminophen
Allopurinol
Cyclophosphamide
Fludarabine
Ondansetron Hydrochloride
Rituximab
Valacyclovir
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:N/A
Supported By:N/A
Return Visit:After completion of treatmet, patients with return to MDACC for follow-up 6,
12, and 24 months later. Follow-up thereafter will be with annual visit until
patients relapse or go on alternative treatment.
Home Care:Patients may receive courses 2-6 at home with their referring physician with
interim visits at MDACC before course 4 and after course 6 for response
assessments.


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Physician Name:William G. Wierda
Dept:Leukemia
For Clinical Trial Enrollment:713-745-0428
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


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