Lenalidomide and Rituximab as Treatment of Chronic Lymphocytic Leukemia

Chronic Lymphocytic Leukemia Clinical Trial

Official title: Lenalidomide in Combination With Rituximab as Treatment for Patients With Relapsed Chronic Lymphocytic Leukemia - RV-CLL-PI-0292

Status Completed

Clinical Trial Summary

The goal of this clinical research study is to learn if the combination of lenalidomide and rituximab can help to control Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) in patients who have already received therapy. The safety of this drug combination will also be studied.

Clinical Trial Description

The Study Drugs:

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 the growth of cancer cells.

Rituximab is designed to bind to a protein, called cluster of differentiation antigen 20 (CD20), that is on the surface of the leukemia cells, allowing the leukemia cells to be destroyed by the immune system.

Drug Administration:

If you are found to be eligible to take part in this study, you will receive rituximab through a needle into your vein 1 time a week in Cycle 1. You will not receive rituximab during Cycle 2, but you will continue to take lenalidomide.You will receive a dose of rituximab by vein on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over 6-8 hours. If the first dose is well tolerated, you may receive the next doses over 2-4 hours. If the doctor thinks it is needed, the next doses may given over a longer time.

On Day 9 of Cycle 1, you will begin taking lenalidomide by mouth once a day. You will then take lenalidomide once a day, every day.

The dose and schedule of lenalidomide may change depending on the side effects you may experience. You should swallow lenalidomide capsules whole with a glass (8 ounces) 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 a dose, it should NOT be made up on another day.

Each study cycle is 4 weeks.

Study Visits:

Once a week during the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests.

After the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2 weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood (about 1 tablespoon) will then be drawn every 4 weeks for routine tests.

At the end of Cycles 3, 6, and 12, you will have a bone marrow biopsy and aspirate to check the status of the disease. Blood (about 1 tablespoon) will be drawn for routine blood tests.

If you stay on study past 12 cycles, once every 6 cycles (Cycles 18, 24, 30, and so on), you will have a bone marrow biopsy and aspirate to check the status of the disease. Blood (about 1 tablespoon) will be drawn for routine blood tests.

Blood (about 1 tablespoon) will be drawn more often if the dose of lenalidomide needs to be changed or if you experience intolerable side effects.

Pregnancy Testing:

Women who are able to become pregnant must have a negative urine or blood (less than 1 teaspoon) pregnancy test 10-14 days and 24 hours before the first dose of lenalidomide, even if they have not had a menstrual period due to treatment of the disease or had only 1 menstrual period in the past 24 months.

If you have regular or no menstrual cycles, you will then have a urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 4 weeks while taking lenalidomide, again as soon as 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 urine or blood (less than 1 teaspoon) pregnancy test every week for the first 4 weeks, then every 2 weeks while taking lenalidomide, again as soon as you have been taken off of lenalidomide therapy, and then at 14 days and 28 days after you have stopped taking lenalidomide.

Length of Study:

You will be on study treatment for about 1 year. You will be taken off study early if you experience intolerable side effects or the disease gets worse.

If the doctor thinks you are benefiting, you may be able to continue taking the study treatment. If you continue, you will follow the same schedule of dosing and study visit schedule.

This is an investigational study. Lenalidomide and rituximab are FDA approved and commercially available. Lenalidomide is approved for the treatment of multiple myeloma and some myelodysplastic syndromes. Rituximab is approved for the treatment of chronic lymphoproliferative disorders and non-Hodgkin's lymphoma. The combination of these drugs to treat CLL and SLL is investigational.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Small Lymphocytic Lymphoma

• NCT number: NCT00759603
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: September 2008
• Completion date: July 2014