IRB Number:

1155-05

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

This research study is being done to:

• test the effects (good and bad) of an extract of green tea (called polyphenon E) on patients who have chronic lymphocytic leukemia (CLL);


• find the highest dose of polyphenon E that can be given without causing unacceptable bad side effects;


• learn how the body handles or processes polyphenon E and polyphenon Es other effects in the body using blood and bone marrow samples.

There is no approved treatment for patients who don't have obvious signs or symptoms of their early stage CLL, despite the fact that the cancer gets worse in many patients with this illness, and in time will require treatment for it.

Who is Eligible to Participate in the Study?

Men or women over the age of 18 with a confirmed diagnosis of Chronic Lymphocytic Leukemia may be eligible to participate in this research study.

Minimum Age:

18

What is Involved With this Study?

This study has two parts:

1. Patients who are in the first part of this study will be assigned to different doses of polyphenon E to try to find the highest dose of this medication that can be given without causing too many bad side effects. To find the highest dose of polyphenon E, the first group of 3-6 patients will receive an initial dose thought to have limited side effects based on a previous study. If these patients do not have severe side effects, the next group of 3-6 patients will get a higher dose of polyphenon E. The dose will be increased until at least some patients have bad side effects. The dose that you get will not increase during this study, but if you have bad side effects your dose may be lowered at future visits.



2. Patients who are in the second part of this study will be assigned to get polyphenon E at the dose level that is thought to be the maximum tolerated dose (MTD), learned from Part 1 of this study. All patients in Part 2 of the study will get the same dose. The dose that you get will not increase during this study, but if you have bad side effects your dose may be lowered at future visits.

All patients will be watched carefully for any serious side effects. These side effects cannot be completely known ahead of time. Phase I studies may involve significant risks for this reason.

How long will the Study run?

You will be allowed to take polyphenon E for up to 6 months unless the side effects are too bad or you decide to stop or if your cancer gets worse, in which case you will have to stop taking it. After your last treatment with Polyphenon E, you will be followed for up to 10 years from the time you started the study so that the researchers can watch your health status.

Who can I Contact for Additional Information on this Trial?

Complete Request Form for Cancer Clinical Trial Information at Mayo Clinic or
For more information about this study or other clinical trial options, please contact our Mayo Clinic Cancer Center Clinical Trials Referral Office.

• Patients living within the United States, call 507-538-7623, or e-mail cancerclinicaltrials@mayo.edu


• Patients living outside the United States may call our International Office at 507-284-8884, or e-mail intl.mcr@mayo.edu.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/02/2009