Last updated on April 2017

Nivolumab in Acute Myeloid Leukemia (AML) in Remission at High Risk for Relapse


Brief description of study

The goal of this clinical research study is to learn if opdivo (nivolumab) can help to control AML. The safety of nivolumab will also be studied.

Detailed Study Description

Study Drug Administration: Each study cycle is 28 days. If you are found to be eligible to take part in this study, you will receive nivolumab by vein over about 1 hour on Days 1 and 15 of each cycle. After Cycle 6, you may receive nivolumab 1 time each month. After you have been on study for about 1 year, you may receive the study drug 1 time every 3 months. If during this time, the disease appears to get worse, you may go back to receiving the study drug on Days 1 and 15 of each cycle. The study doctor will discuss this with you. On Day 1 of Cycle 1, you will stay in the clinic for up to 2 hours after the end of your infusion so the study staff can check on your health. After that, you will stay in the clinic for about 1 hour after the end of your infusion. Study Visits: On Days 1 and 15 of Cycle 1, one time during Cycles 2 and 3, and then every 8-12 weeks after that until Cycle 6, you will have a physical exam. If you continue therapy after Cycle 6, you will have a physical exam every 2-3 months. One (1) time each week during Cycle 1, every 2 weeks during Cycles 2 and 3, and then 1 time during each cycle after that, blood (about 2-3 teaspoons) will be drawn for routine tests. These tests may be done more often if your doctor thinks it is needed. On Day 28 of Cycles 1, 3, and 5 and then one time every 3 months after that, you will have a bone marrow aspiration to check the status of the disease and for cytogenetic testing. Length of Study: You may continue receiving the study drug for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug 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 you have completed the End-of-Treatment Visit. End-of-Treatment Visit: Within 30 days after your last dose of study drug: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. - If it has not been done within the last 6 weeks and the doctor thinks it is possible, you will have a bone marrow aspirate to check the status of the disease and for cytogenetic testing. If you cannot come to the clinic for the End-of-Treatment visit, you will be called by the study staff and asked about your health. This call should last about 5-10 minutes. This is an investigational study. Nivolumab is FDA approved and commercially available for the treatment of melanoma. It is considered investigational to use nivolumab to treat AML. The study doctor can explain how the study drug is designed to work. Up to 30 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02532231

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Tapan Kadia, MD

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