This phase 1 and 2 trial aims to determine the effectiveness and optimal dose of Axitinib and Bosutinib in patients with chronic myeloid leukemia. The outcome to be measured is the response to treatment based on genetic analysis and blood cell count, and the side effects. The study is located in Houston, Texas, United States.
The details
Chronic myeloid leukemia (CML) is a cancer of the blood forming cells. It can be grouped based on the progress of the disease. In chronic phase, symptoms are mild and there are less immature white blood cells. In accelerated phase, there are more immature white blood cells and symptoms are more present. In blast phase, there are high numbers of immature white blood cells and more severe symptoms. Standard treatment for CML is use of a group of drugs called tyrosine kinase inhibitors. Axitinib and bosutinib are both a type of tyrosine kinase inhibitor that is being studied in CML.
This trial will examine the effectiveness of this therapy combination in patients in both chronic and advanced phase CML. The main outcome to be measured is the rate of response based on the level of reduction of certain abnormal chromosomes.
Who are they looking for?
This study is recruiting 52 participants with chronic myeloid leukemia. Participants should have failed treatment to at least 3 tyrosine kinase inhibitors if in chronic phase or at least 1 tyrosine kinase inhibitor if in acute phase. Women of childbearing potential must practice 2 effective methods of contraception. Male participants must also agree to use contraception.
Participants should not have previously received bosutinib or axitinib. Participants should not have unstable angina, heart attack, stroke, deep vein thrombosis (blood clot) or other thrombotic event, abnormal heart rhythm or severe heart failure within 6 months of starting the study. Participants should not have uncontrolled high blood pressure. Participants should not be receiving anticoagulants (drugs that stop clotting) during the study.
How will it work
Participants in the chronic phase will receive axitinib if they have the T315I mutation and receive bosutinib if they do not have this mutation. Axitinib will be taken twice daily by mouth and bosutinib will be taken once daily by mouth. They will receive the drug for 3 months, after which they will switch to the other drug for 3 months. This continues every 3 months while on the study.
Participants in the advanced phase will receive axitinib twice daily by mouth and bosutinib once daily by mouth. In the second part of the study, the dose will be increased to determine the maximum dose that can be tolerated. This will occur over 1 month.
At 3 months, the blood count level will be measured to determine if there is remission. At 12 months, genetic analysis will be performed to see if there is a major response to treatment.
