Trial Information

A Pilot Open Label Study to Investigate the Role of Lenalidomide in Improving Cancer Related Sleep in CLL Patients Over 65 Years of Age Experiencing Clinically Significant Fatigue

In this study, researchers are trying to learn if treatments to kill cancer cells such as
lenalidomide and/or radiation therapy can also help to control sleep problems and fatigue in
patients with CLL and/or breast cancer.

Study Procedures:

If you are found to be eligible to take part in this study, before you begin taking
chemotherapy on Day 1, the following tests and procedures will be performed:

- Blood (about 2 tablespoons) will be drawn to learn about the relationship between
changes in specific protein levels in the blood, your level of fatigue, and sleep
problems.

- Your complete medical history will be recorded.

- You will have a physical exam.

- You will also complete 4 questionnaires that will ask you questions about your symptoms
and your sleep patterns. They will take 20-30 minutes to complete in total.

From Day 1 through the end of 1st cycle (+/- 3 days), you will wear a watch that records
your body movements. This is called an actigraph.

On Day 15 (+/- 3 days), you will be called by a member of the research staff. During these
calls, you will complete the 4 questionnaires that ask about symptoms you are having and
about your sleep patterns.

On Day 29 (+/- 3 days) and end of 1st cycle (+/- 3 days), you will have a clinic visit. At
this visit, you will complete the 4 questionnaires that ask about symptoms you are having
and your sleep patterns. Blood (about 2 tablespoons) will also be drawn to learn about the
relationship between changes in protein levels in the blood, your level of fatigue, and
sleep problems.

Sleep Tests:

You will have a sleep test before starting chemotherapy on Day 1 and again on end of 1st
cycle (+/- 3 days). The sleep test is done overnight in a sleep lab.

A sleep study, called a polysomnogram, is a test that records a person's physical state
during various stages of sleep and wakefulness. The study provides information about a
person's sleep stages, body position, blood oxygen levels, breathing events, muscle tone,
heart rate, snoring, and general sleep behavior.

When you arrive at the Sleep Center Laboratory you will be shown to your private room. You
will complete a questionnaire that will ask questions about how much you slept the night
before, how active you have been, and about any caffeine or alcohol you may have had. The
questionnaire will take about 5 minutes to complete.

The member of the sleep lab staff will connect sensors that will record your brain waves,
muscle tone, eye movements, air flow, and limb movements while you sleep. The sensors are
applied to specific areas of your body with paste and gauze or tape. The monitoring
equipment is painless and should not interfere with your sleep.

It is not a problem to have a drink of water or to use the restroom during the sleep study.
The member of the sleep lab staff will monitor the sleep study from another room throughout
the night and will wake you in the morning to remove the sensors.

In the morning, you will complete a questionnaire about how you slept and how you are
feeling. It will take about 5 minutes to complete.

Length of Study:

You will be on study up to end of 1st cycle (+/- 3 days).

This is an investigational study. Sleep studies are a standard test for patients with sleep
problems.

The blood tests performed for this study and the sleep test will be performed at no cost to
you.

Up to 12 patients will take part in this study. All will be enrolled at M. D. Anderson.