IRB Number:

07-002156

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 previously untreated B-cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This study is being done to learn about the effectiveness and side effects of pentostatin, cyclophosphamide and rituximab (PCR) followed by lenalidomide for previously untreated CLL/SLL and to learn whether lenalidomide treatment after treatment with PCR can eliminate residual CLL/SLL that remains after PCR.

Who is Eligible to Participate in the Study?

-Age 18 or older
-Diagnosed with previously untreated B-cell Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

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

What is Involved With this Study?

This study is divided into 4 phases: induction, consolidation, continuation, and observation.

During the induction phase, patients will receive pentostatin, cyclophosphamide, and rituximab (PCR) as an intravenous infusion (IV - into a vein). It is hoped that this phase of the study will put the patient's CLL/SLL into remission. This treatment will be repeated 1 day out of every three weeks; this is considered 1 cycle of treatment. For the first cycle only, the patient's dose of rituximab will be given over 2 days. Patients will receive a total of six cycles of treatment with PCR.

The day after each treatment with pentostatin and cyclophosphamide patients will get a subcutaneous injection (into the skin) with a drug called Neulasta (pegfilgrastim). This drug helps infection fighting cells (neutrophils - a kind of white blood cell) recover from the effects of chemotherapy more quickly. It may be possible for the patient to get these injections at home; the doctor will talk this over with the patient.

During the consolidation phase, patients will be taking lenalidomide once per day by mouth for three weeks out of four weeks; this is considered 1 cycle of treatment. The patient will receive a total of six cycles of treatment with lenalidomide. Patients will also be asked to keep a diary to make sure they are taking the study drug at the correct time points. The intent of this part of the study is to get rid of any leukemia cells that were not killed during the first part of the trial.

During the continuation phase, only patients who still have evidence of disease after the consolidation phase will take part in this phase. If the patient still has residual leukemia cells after the second part of the study, they will continue on lenalidomide by mouth to try to eliminate these cells. The patient will continue to take lenalidomide as previously described and keep track in a diary. The doctor will reevaluate the patient every three months to see if these cells have been eliminated at which time the patient would stop lenalidomide and enter the observation phase of the study.

The patient will start the observation phase if they have no detectable leukemia cells at the end of the consolidation phase (skipping the continuation phase) or anytime during the continuation phase. During the observation phase the patient will follow-up with their doctor every three months for up to three years. During this part of the study the doctors will monitor for any signs of leukemia recurrence by performing routine blood tests, exams, and procedures.

Throughout the study the patient will have blood collected for special research tests that will look for evidence of recurrence of leukemia cells (called minimal residual disease). Since the clinical importance of finding "minimal residual disease" is unknown the results of these tests will be used to determine how long the patient will continue treatment with lenalidomide.

How long will the Study run?

Patients will be in the study for five years.

Sponsor(s): Mayo Clinic

Study Activation/Registration Date: 02/28/2008

IRB Review and Approval Date: 01/24/2008

Study Type: Treatment

Projected Accrual: The plan is to have 45 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: Tait D. Shanafelt, 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
• Jacksonville, FL
• Scottsdale and Phoenix, AZ

Last updated: 05/08/2008