CLINICAL TRIAL SUMMARY

MDACC Study No:2012-0086 (clinicaltrials.gov NCT No: NCT01752426)
Title:A Pilot Study to determine the effects of the Bruton’s tyrosine kinase (Btk)
inhibitor PCI-32765 on leukemia cell kinetics and trafficking, using Heavy Water
Labeling in subjects with Chronic Lymphocytic Leukemia (CLL) and Small
Lymphocytic Lymphoma (SLL).
Principal Investigator:Jan A. Burger
Treatment Agent:Heavy Water; PCI-32765
Study Status:Closed
Study Description:The goal of this clinical research study is to learn how PCI-32765 (ibrutinib)
may affect the life cycle of blood-cancer cells. Cancer cells will be "labeled"
with heavy water to learn about their birth rates and death rates.

Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins
inside cells that help cells live and grow. The study drug is designed to
inhibit or "block" the activity of a type of kinase that helps blood-cancer
cells live and grow. By blocking the activity of this specific kinase, it is
possible that the study drug may kill the cancer cells or stop them from
growing.

Heavy water (2H2O) is a special type of water that is designed to help
researchers learn how quickly cancer cells in the body reproduce.

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Disease Group:Leukemia
Phase of Study:N/A
Treatment Agents:Heavy Water
PCI-32765
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:
Supported By:Pharmacyclics
Return Visit:
Home Care:


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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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