Clinical trial NCT00267059
Conditions: Chronic Lymphocytic Leukemia Leukemia
Keywords: Chronic Lymphocytic Leukemia Lenalidomide Revlimid CLL
Sponsor: M.D. Anderson Cancer Center
Start date: 2005-12-01; Completion date: 2009-08-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this clinical research study is to learn if lenalidomide (Revlimid®) can help to control CLL in patients who have already received standard therapy. The safety of lenalidomide will also be studied.

Detailed description:
Lenalidomide is designed to change the body's immune system and may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells.

Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. You will have a complete medical history and physical exam. Blood (between 2-4 teaspoons) and urine will be collected for routine tests. For patients taking Coumadin, blood will be collected (2-4 teaspoons) to measure anticoagulation in order to closely monitor your clotting ability for the purpose of adjusting your Coumadin dose, if necessary. This blood test is called an INR (International Standard Method to follow anticoagulation). You will have a bone marrow biopsy and aspirate. To collect a bone marrow biopsy and aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. These two collections are performed as one single procedure. You also will have an electrocardiogram (ECG - a test that measures the electrical activity of the heart). Women who are able to have children must have a negative urine pregnancy test.

If you are found to be eligible to take part in this study, you will take lenalidomide by mouth every morning at about the same time for 28 days. This is considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down depending on how your disease responds and the side effects you experience.

During this study, you will have blood samples (about 1 tablespoon each) taken once a week during the Cycle 1 until a stable dose of lenalidomide has been found. You will then have about 1 tablespoon of blood drawn every 2 weeks for an additional cycle and then once a month from then on while you are on study. Blood tests (about 1 tablespoon each) may be done more frequently if the dose of medication needs to be adjusted or if you experience side effects. Every month during the first 3 months, you will have a physical exam to see how you are doing. You will have a physical exam every 3 months from then on. After the first 3 months of treatment, a bone marrow biopsy and aspirate is going to be collected to evaluate your response to the treatment. In participants who continue to receive treatment, a bone marrow biopsy and aspiration are going to be repeated every 6 months during the first year, and then once a year after that while on study.

You will be required to return to M. D. Anderson at least once a month, for the first 3 months, and until a stable dose of lenalidomide has been established. Following this, you will be required to return at least every 3 months while taking the medication . Women who are able to have children must have a negative pregnancy test 10-14 days before the start of therapy and a repeat pregnancy test 24 hours before the start of lenalidomide, every week for the first 4 weeks, every 4 weeks if they have regular menstruation, every 2 weeks if their periods are irregular, and 30 days after they stop taking lenalidomide. Only if you have had a hysterectomy or no menstrual periods for at least 24 months in a row, will you not be required to have these pregnancy tests and use birth control.

You may continue to receive treatment as long as your disease is responding and no intolerable side effects occur. You will be taken off study if the disease gets worse or intolerable side effects occur.

This is an investigational study. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for multiple myeloma. Lenalidomide use in chronic lymphocytic leukemia is considered experimental. Up to 45 patients may take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: None
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 10 mg/day, orally once a day for 28 days

Protocol documents: