Last updated on March 2017

Bosutinib Dose-Optimization Study in Chronic Myeloid Leukemia (CML)


Brief description of study

Bosutinib is a type of tyrosine kinase inhibitor (TKI) which is commonly used for the treatment of chronic phase chronic myelogenous leukemia (CP CML). The standard dose of bosutinib often causes temporary, but severe, diarrhea which goes away after bosutinib is stopped or the dose is lowered. The goal of this clinical research study it to learn if a lower dose of bosutinib is as effective as the standard dose. Researchers think that by starting with a lower dose of bosutinib and slowly increasing the dose (if needed), the likelihood and severity of diarrhea and other side effects may be lowered in patients with CP CML. To help researchers learn if the lower dose of bosutinib is as effective as the regular dose, researchers will test your cytogenetic response to the drug. Cytogenetic testing looks at how genetic changes to cells (in this study, the BRC-ABL protein and Philadelphia chromosome) may affect how the disease may react to the study drug.

Detailed Study Description

Study Drug Administration: Each study cycle is 28 days. You will take bosutinib tablets by mouth 1 time each morning every cycle while you are on study. You should take your dose of study drug with breakfast and a small cup of water (about 6 ounces). If you miss or vomit a dose of bosutinib, do not retake the dose. Wait and take your next dose as scheduled. If the study doctor thinks it is in your best interest, the dose of study drug you receive may be raised or lowered, depending on how you react to the study drug. Study Visits: On Days 8 and 15 of Cycle 1, blood (about 2 teaspoons) will be drawn for routine tests. If your doctor thinks it is appropriate to do so, you may have this blood drawn at a local lab or doctor's office closer to your home. The results will be sent to the study doctor for review. The study doctor or study staff may also call you to discuss the results of the blood draw and to ask how you are doing. This call should last about 5-10 minutes. On Day 28 of Cycle 1: - You will have a physical exam. - Blood (about 3-4 teaspoons) will be drawn for routine tests. - You will have an EKG. On Day 28 of Cycle 2: - Blood (about 3-4 teaspoons) will be drawn for routine tests. - If your doctor thinks it is appropriate to do so, you may have this blood drawn at a local lab or doctor's office closer to your home. The results will be sent to the study doctor for review. The study doctor or study staff may also call you to discuss the results of the blood draw and to ask how you are doing. This call should last about 5-10 minutes. On Day 28 of Cycles 3, 6, 9, 15, 18, and 21: - You will have a physical exam. - Blood (about 3-4 teaspoons) will be drawn for routine tests and for BCR-ABL level testing. - You will have a bone marrow aspirate for cytogenetic testing, to check the status of the disease, and to check for genetic mutations. Based on the results of your bone marrow aspirate, the study doctor may decide that it is in your best interest to stop having bone marrow aspirates and to continue performing these tests on your blood samples instead. The study doctor will tell you if you will stop having bone marrow aspirates. - During Cycle 3, you will have an EKG. On Day 28 of Cycles 12 and 24: - You will have a physical exam. - Blood (about 3-4 teaspoons) will be drawn for routine tests. - You will have a bone marrow aspirate for cytogenetic testing and to check the status of the disease. - You will have either an ECHO or MUGA scan. - You will complete a questionnaire about your symptoms and how you view your health. If the disease appears to get worse and the doctor thinks it is needed, these tests/procedures may be repeated at any time to check the status of the disease. Length of Study: You may continue taking the study drug for up to 2 years. If the doctor thinks it is in your best interest, you may be able to continue taking bosutinib at the dose you were taking at the end of the study, as part of your regular care. 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 long-term follow-up has been completed. End-of-Study Visit: If you stopped taking the study drug before Cycle 24, within 7-28 days after your last dose of study drug: - You will have a physical exam. - Blood (about 3-4 teaspoons) will be drawn for routine tests and for BCR-ABL level testing. - You will have a bone marrow aspirate for cytogenetic testing, to check the status of the disease, and to check for genetic mutations. - You will have either an ECHO or MUGA scan. - You will complete a questionnaire about your symptoms and how you view your health. Long-Term Follow-Up: You will be called by a member of the study staff every 12 weeks for up to 2 years and then every 24 weeks after that for the next 2 years. During these calls, you will be asked how you are doing, if you have started any other anti-cancer treatment, and about any side effects you may be having. After that, you will be called 4 times each year until the study ends or you withdraw from the study. Each phone call should last about 5-10 minutes. If the doctor thinks it is in your best interest, you may come back to the clinic for additional follow-up, as part of your standard treatment. This is an investigational study. This is an investigational study. Bosutinib is FDA approved and commercially available for the treatment of chronic phase CML. It is considered investigational to use bosutinib at a lower dose compared to the standard dose. The study doctor can explain how the study drug is designed to work. Up to 42 participants will take part in this study. All will be enrolled at MD Anderson.

Clinical Study Identifier: NCT02906696

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Philip A. Thompson, MBBS

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