Last updated on May 2017

Study of Obinutuzumab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma


Brief description of study

The goal of this clinical research study is to learn if combining obinutuzumab and lenalidomide can help to control previously untreated FL.

Detailed Study Description

Study Drug Administration: Each study cycle is 28 days. You will receive obinutuzumab by vein over about 4-6 hours on Days 1, 8, and 15 of Cycle 1 and then on Day 1 of Cycles 2-6 and Cycle 8 and then every even-numbered cycle after that (Cycles 10, 12, 14, and so on) up to Cycle 30. About 30-60 minutes before each dose of obinutuzumab, you will be given standard drugs to help decrease the risk of side effects. You may ask the study staff for information about how the drugs are given and their risks. You will also take lenalidomide capsules by mouth on Days 1-21 of Cycles 1-6. Each dose of lenalidomide should be taken at about the same time each day, either with or without food. After Cycle 6, you may receive up to an additional 12 cycles of lenalidomide based on how you are responding to lenalidomide. The doctor will discuss this with you. Lenalidomide capsules should be swallowed whole with water and should not be opened, broken, or chewed. If a dose is missed, it can be taken as soon as possible on the same day, however you should take your next dose according to your normal dosing schedule. Do not take an extra "make-up" dose if you miss a dose. Study Visits: On Day 1 of Cycle 1: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine testing. On Days 8 and 15 of Cycle 1: - You will have a physical exam. - Blood (about 3 teaspoons) will be drawn for routine tests. On Day 1 of Cycles 2-18: - You will have a physical exam. - Blood (about 3 teaspoons) will be drawn for routine tests. - You will have an MRI, CT, or PET/CT scan (Cycles 4, 7, 10, and 14). On Day 1 of Cycle 20 and then every even-numbered cycle after that (Cycles 22, 24, 26, and so on): - You will have a physical exam. - Blood (about 3 teaspoons) will be drawn for routine tests. - You will have an MRI, CT, or PET/CT scan (Cycles 20 and 26). If you can become pregnant and you have regular or no menstrual cycles, blood (about 3 teaspoons) will be drawn for a pregnancy test every week during Cycle 1 and then 1 time every cycle after that. If you can become pregnant and you have irregular menstrual cycles, you will have this testing every week during Cycle 1 and then every 2 weeks after that. Length of Study: You may receive obinutuzumab for up to 30 cycles and you may receive lenalidomide for up to 18 cycles. 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. Your participation in this study will be over after about 2 years of follow-up visits. End-of-Treatment Visit: About 4 weeks (±14 days) after your last dose of study drugs: - You will have a physical exam. - Blood (about 6 teaspoons) will be drawn for routine testing. - You will have an MRI, CT, or PET/CT. - If you can become pregnant, blood (about 3 teaspoons) will be drawn for a pregnancy test. If you have a regular menstrual period, you will have this test within 28 days after your last dose of study drugs. If you have an irregular menstrual cycle, this test will be performed within 14 and 28 days after your last dose of study drugs. If you have a side effect at the end-of-treatment visit, the study doctor may call you or collect information from your medical record for up to 30 days after the end-of-treatment visit to check on your health until the side effect goes away or becomes stable. If you are called, each call should take about 5 minutes. Follow-Up: Every 6 months for the first 18 months and then 1 time every year after that for up to 2years after your last dose of study drugs: - You will have a physical exam. - Blood (about 3 teaspoons) will be drawn for routine testing. - You will have an MRI, CT, or PET/CT scan. This is an investigational study. Obinutuzumab is FDA approved and commercially available for the treatment of chronic lymphocytic leukemia (CLL). Lenalidomide is FDA approved and commercially available for the treatment of different types of lymphoma and multiple myeloma (MM). It is considered investigational to combine obinutuzumab and lenalidomide to treat FL. The study doctor can explain how the study drugs are designed to work. Up 60 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02871219

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Loretta Nastoupil, MD

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