IRB Number:

968-04

Trial Status:

Open for Enrollment

Phase: I

Why is this study being done?

The purpose of this research study is to evaluate the use of CpG 7909. CpG 7909 is a short strand of DNA, the genetic material found in cells. CpG 7909 has the potential to stimulate the immune system, and we are studying these effects to learn if CpG 7909 has potentially beneficial effects in people with chronic lymphocytic leukemia. The purpose of this research study is to see if we can measure biological changes in Chronic Lymphocytic Leukemia (CLL) cells and chemicals in your blood after receiving CpG 7909.

Who is Eligible to Participate in the Study?

A diagnosis of CLL supported by clinical immunophenotyping with co-expression of CD5 (without other pan-T cell markers) and CD19/20, dim surface Ig, and presence of CD23.
An absolute lymphocytosis of > 5,000/ul. Morphologically, the lymphocytes must appear mature with < 55% prolymphocytes
Lymphocyte immunophenotype from the peripheral blood or marrow must reveal a predominant B-cell monoclonal population of small to moderate size lymphocytes, with fewer than 55% prolymphocytes, atypical lymphocytes, or lymphoblasts morphologically determined by manual differential. Lymphocytes should demonstrate co-expression of a B-cell marker (CD19, CD20, CD23, CD24) with the CD5 antigen, in the absence of other pan-T-cell markers. Peripheral blood should be sent for interphase fluorescence in situ hybridization for 11q22.3, 17p13.1, 13q14.3, 13q34, and 12 cen . This need not be repeated if performed within 6 months of enrollment.

What is Involved With this Study?

To determine if you can receive the CpG 7909, you will have a physical exam and blood work. We will gather information from you and your doctors about how your leukemia was treated in the past. After this screening visit, if you are eligible to continue in the research study, you will return to receive the CpG 7909. This is a dose increase study. People who enter this study early on will receive lower doses of the study drug than people who enroll later in the study.

You will receive a single injection of CpG 7909 either by injection into a vein OR by injection under the skin. You will have a 50/50 chance of receiving the drug by either method and this will be determined by chance as by flipping a coin. You will have several tubes of blood drawn at 2, 3, 4, and 6 hours after receiving the study drug (1/3 tablespoon each time).

This blood will be sent to Coley Pharmaceuticals to test the amount of drug in your blood stream. You will be asked to return to the clinic 1, 3 and 7 days after the study drug was given to have blood work done, including a blood count to see how the study drug affects your CLL.

Four weeks after receiving CpG 7909, you will return to the clinic to have a physical, vital signs, and blood work. At this time, you will have a blood count performed to determine the effect of the study drug on your CLL.

How long will the Study run?

You will be in the study for at least 4 weeks. You will receive a single dose of study drug. The day you receive the study drug, you will be monitored for 6 hours. You will receive follow-up phone calls over the next four weeks to see if you have any side effects.

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: 05/07/2008