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Number: CALGB E1912 Principal Investigator: Bartlett, Nancy
Title: A Randomized Phase III Study of Ibrutinib (PCI-32765)-based Therapy vs Standard Fludarabine, Cyclophosphamide, and Rituximab (FCR) Chemoimmunotherapy in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)
Phase: III Disease Site: Lymphoid Leukemia
Participating Site(s):
 
Main Campus
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South County
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St. Peters
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West County
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Contact: 800-600-3606 or info@ccadmin.wustl.edu

Description:
The purpose of this study is to compare the effects, good and/or bad, of two different therapies that include combinations of the drugs rituximab, fludarabine, cyclophosphamide and Ibrutinib have on you and your CLL. The first three of these drugs are standard treatments for CLL. Fludarabine and cyclophosphamide have been approved by the Food and Drug Administration (FDA) for the treatment of CLL. Rituximab is approved for the treatment of CLL when given in combination with fludarabine and cyclophosphamide and is also approved for treatment of non-Hodgkin lymphoma and rheumatoid arthritis. Ibrutinib has been previously studied in patients with CLL, and has been approved by the FDA for use in previously treated CLL patients. In this study, ibrutinib is investigational because it will be given to previously untreated CLL patients and administered in combination with rituximab. This research is being done because currently there is no proven cure for this type of cancer.
 
More Information:
clinicaltrials.gov link
Internal Protocol Documents (requires Siteman administrative database password)