Clinical trial NCT00535873
Conditions: Leukemia CLL Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma
Keywords: Leukemia CLL chronic lymphocytic leukemia SLL small lymphocytic lymphoma Untreated CLL Lenalidomide CC-5013 Revlimid Oral
Sponsor: M.D. Anderson Cancer Center
Start date: 2007-10-01; Completion date: 2013-02-01
Enrollment: 61 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

* To assess the activity of lenalidomide in patients with previously untreated chronic lymphocytic leukemia (CLL) age 65 and older.

Secondary Objective:

* To assess the tolerability of lenalidomide in patients with untreated CLL age 65 and older

Detailed description:
The Study Drug:

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.

Drug Administration:

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 each day for 28 days. Twenty-eight (28) days is considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down, depending on how the disease responds and the side effects you may experience. Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose).

Concomitant Medications:

Allopurinol will be prescribed for you during the first 14 days of treatment. This medication is taken by mouth and will help protect your kidney function.

Study Visits:

During this study, you will have blood (about 1 tablespoon each) drawn every other week until the best dose of lenalidomide has been found. Blood tests (about 1 tablespoon each) may be done more often if the dose of medication needs to be changed or if you experience intolerable side effects. Women who are able to have children must have a negative urine or blood (less than 1 teaspoon) pregnancy test 10 - 14 days and 24 hours before starting lenalidomide therapy, even if they have not had a menstrual period due to treatment of the disease or had as little as one menstrual period in the past 24 months. If you have regular or no menstrual cycles, you will then have pregnancy tests every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 28 days after you have stopped taking lenalidomide. If you have irregular menstrual cycles, you will have pregnancy tests every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again when you have been taken off of lenalidomide therapy, and then 14 days and 28 days after you have stopped taking lenalidomide. Every month for the first 3 months, then at Months 6, 9, 12, and 15 you will have a physical exam to see how you are doing. After the 15-month visit, you will have a physical exam every 6 months.

After the first 3 months, and then every 6 months after that (unless your study doctor does not think it is necessary), you will have a bone marrow biopsy and aspirate performed to check the status of the disease.

Length of Study:

You may stay on this study for as long as you are benefitting. You will be taken off this study early if the disease gets worse or intolerable side effects occur.

This is an investigational study. Lenalidomide is FDA approved and commercially available. Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Its use in this study, for this disease, is investigational. Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms: arm 1: Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: Starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.

Protocol documents: