IRB Number:

07-002087

Trial Status:

Open for Enrollment

Phase: II

Why is this study being done?

Patients are being asked to take part in this research study because they have been diagnosed with chronic lymphocytic leukemia (CLL). This study is being done to see how their disease responds to treatment.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with chronic lymphocytic leukemia (CLL)
-Received no prior treatment for CLL (previous corticosteroids are allowed.)

*More specific, detailed eligibility and/ or exclusion criteria are associated with this trial.

What is Involved With this Study?

Patients will get treated for six weeks while on this study. The first week, they will get GMCSF three times (on Monday, Wednesday, and Friday) as a subcutaneous injection
(injected under the skin with a needle) and alemtuzumab three times (on Wednesday, Thursday, and Friday) as a subcutaneous injection. For the next four weeks, they will get GM-CSF and alemtuzumab three times per week (on Mondays, Wednesdays, and Fridays) as a subcutaneous injection. On Wednesdays, besides GM-CSF and alemtuzumab, patients will also get rituximab as an intravenous infusion (IV-into a vein). If the patient does not already have an IV 1line in place, one will be inserted into a vein in their arm. Then they will get GM-CSF three times per week (on Monday, Wednesday, and Friday) as a subcutaneous injection for 1 more week. Patients will be taught how to give themselves the subcutaneous injections of the GM-CSF and alemtuzumab. Patients will also be asked to keep a diary to make sure they are given the study drug at the correct time points.

How long will the Study run?

Patients will be in the study for five years from the time they are registered on the study.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 02/11/2008

IRB Review and Approval Date: 01/10/2008

Study Type: Treatment

Projected Accrual: The plan is to have up to 33 people take part in this study at Mayo Clinic.

Costs of Study:There may be standard patient care costs related to participating in a cancer research study.

Principal Investigator: Clive S. Zent, MD

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
• Scottsdale and Phoenix, AZ

Last updated: 05/12/2008