Last updated on March 2017

Combination of Lenalidomide and Obinutuzumab (GA101) in Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)


Brief description of study

The goal of this clinical research study is to learn if the combination of lenalidomide and obinutuzumab can help to control CLL or SLL. The safety of this drug combination will also be studied.

Detailed Study Description

Study Drug Administration: If you are found to be eligible to take part in this study, you will receive obinutuzumab by vein over about 3-4 hours on Days 1, 2, 8, and 15 of Cycle 1, and then on Day 1 of Cycles 2-6. Starting on Day 9 of Cycle 1, you will take lenalidomide capsules by mouth 1 time each day. You should swallow your dose of lenalidomide whole with a glass (about 8 ounces) of water, at about 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 only. Do not make up any doses of lenalidomide on the next day. If the doctor thinks it is needed, you may have to take lenalidomide more or less often and the dose you are taking may change. Your doctor will discuss this with you. Study Visits: Each study cycle is 28 days. Each week during Cycle 1 and during the first week of Cycle 2, blood (about 2 teaspoons) will be drawn for routine tests. After Cycle 2, this blood draw will happen every 14 or 28 days, depending on what the doctor thinks is needed. If you are able to become pregnant, at the beginning of each week of Cycle 1, blood (about 1 teaspoon) or urine will be collected for a pregnancy test. After Cycle 1, you will have this pregnancy test every 14 or 28 days, depending on what the doctor thinks is needed. On Day 1 (+/-10 days) of Cycles 2-6: - You will have a physical exam. - Blood (about 2 teaspoons) will be drawn to check the status of the disease and to check your immune system. After Cycle 3, 6, 12, and every 6 cycles after that (Cycles 18, 24, 30, and so on), (+/-14 days from Day 1 of subsequent cycle): - You will have a physical exam - Blood (about 2 teaspoons) will be drawn to check the status of the disease and to check your immune system. - You will have a bone marrow biopsy/aspiration to check the status of the disease, to check your immune system, for cytogenic testing, biomarker testing (including genetic biomarkers), and flow cytometry testing. At any time during the study, if the doctor thinks it is needed, you will have radiographic testing to check the status of the disease. Length of Treatment: You may continue taking lenalidomide for as long as the doctor thinks it is in your best interest. You may receive up to 6 cycles of obinutuzumab. You will no longer be able to take the study drugs if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. This is an investigational study. Lenalidomide is FDA approved and commercially available for the treatment of multiple myeloma (MM), mantle cell lymphoma (MCL) and myelodysplastic syndromes (MDS). Lenalidomide is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. Obinutuzumab is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). It is investigational to give lenalidomide and obinutuzumab together to treat CLL or SLL. The study doctor can explain how the study drug(s) are designed to work. Up to 60 patients will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02225275

Contact Investigators or Research Sites near you

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Alessandra Ferrajoli, MD,BS

University of Texas MD Anderson Cancer Center
Houston, TX United States
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