Last updated on June 2017

Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma


Brief description of study

The goal of this clinical research study is to learn if adding Imbruvica (ibrutinib) to Rituxan (rituximab) and Revlimid (lenalidomide) can help to control previously untreated follicular lymphoma (FL) and marginal zone lymphoma.

Detailed Study Description

Study Drug Administration: Each study cycle is 28 days. You will take lenalidomide by mouth on Days 1-21 of Cycle 1. After Cycle 1, your dose of lenalidomide will increase and you will take it by mouth on Days 1-21 of Cycles 2-12. You should return all empty or leftover lenalidomide capsules/bottles to the study staff. Do not share the study drug with anyone. You will receive rituximab by vein over about 4-6 hours on Days 1, 8, 15, and 22 of Cycle 1 and then on Day 1 of Cycles 2-12. You will also receive ibrutinib by mouth 1 time every day of Cycles 1-12. You should take your dose ibrutinib with a cup (about 8 ounces) of water. Study Visits: On Day 1 of Cycle 1: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. - Blood (about 2-3 teaspoons) will be drawn before your dose of rituximab for biomarker testing . Biomarkers are found in the blood/tissue and may be related to your reaction to the study drugs. On Days 8, 15, and 22 of Cycle 1: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. If you can become pregnant, this blood draw will also include a pregnancy test. - Blood (about 2-3 teaspoons) will be drawn for biomarker testing on Day 15 only. On Day 1 of Cycles 2 and beyond: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. If you can become pregnant, this blood draw will also include a pregnancy test. - During Cycles 4 and 7 only, you will have an MRI or PET/CT scan. - During Cycles 2 and 7 only, blood (about 2-3 teaspoons) will be drawn for biomarker testing. Women who can become pregnant and have irregular menstrual periods will have the blood pregnancy test (about 1 teaspoon) repeated on Day 15 of every cycle. Length of Treatment: You may receive the study drugs for up to 12 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 on this study will be over after the follow-up visits. End-of-Treatment Visits: About 4 weeks after your last dose of study drugs: - You will have a physical exam. - Blood (about 4-6 teaspoons) will be drawn for routine tests and biomarker testing. - You will have an MRI or PET/CT scan. You will also be asked about any side effects you may have had and if you have been hospitalized. If you can become pregnant, you will have a pregnancy test when you are taken off lenalidomide. The test will be repeated either 28 days after your last dose (if you have regular or no menstrual cycles), or 14 and 28 days after your last dose (if you have irregular menstrual cycles). Follow Up Visits: After the End-of-Treatment visit, you will have follow-up visits every 12 weeks (± 2 weeks) for the first year and then every 24 weeks (± 4 weeks) after that. Follow-up will stop when 3 years have passed since the last study participant enrolled received their last dose of study drug. If you completed 12 cycles of study treatment, at each follow-up visit: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. - You will have an MRI or PET/CT scan. If you stopped study treatment early because the disease got worse or came back, you will be called and asked about any new therapies you have started, any symptoms you may be having, and about your overall health. Each call should take about 5-10 minutes. This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulinemia. Lenalidomide is FDA approved and commercially available for the treatment of multiple myeloma (MM), mantle cell lymphoma, and myelodysplastic syndrome (MDS). Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin lymphoma (NHL). It is considered investigational to use ibrutinib, lenalidomide, and rituximab to treat FL and marginal zone lymphoma. Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02532257

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Loretta Nastoupil, MD

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