Last updated on January 2017

Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): Phase II


Brief description of study

The goal of this clinical research study is to learn if Jakafi (ruxolitinib) can help to control fatigue and other symptoms in patients with CLL who do not need treatment for the cancer. Researchers also want to learn if ruxolitinib can decrease the size of enlarged lymph nodes and/or lower the number of CLL cells in the blood.

Detailed Study Description

Study Drug Administration: If you are found to be eligible to take part in this study, you will take ruxolitinib pills 2 times a day, about 12 hours apart. If you miss a dose, do not take an extra dose. Instead, take your next dose on time. If you vomit a dose within 30 minutes after taking it, you can take an extra dose to make it up for it. If you vomit and more than 30 minutes has passed since you took ruxolitinib, do not take an extra dose. Instead, take your next dose on time. If needed, your doctor may raise or lower your dose of ruxolitinib, based on how the disease is responding to the drug or if you are experiencing severe side effects. Study Visits: At about 2 weeks and then 3 months after your first study drug dose: - Blood (about 1 teaspoon) will be drawn for cytokine testing. - You will fill out the symptom questionnaire during your clinic visit. About every 1-2 months: - You will have a physical exam. - Blood (about 1 teaspoon) will be drawn for routine tests. If it is more convenient, some of the study tests and procedures can be done at your home doctor's office. Length of Treatment: You may receive the study drug for up to 2 years. At that point, you may be allowed to continue taking the study drug for as long as the sponsor provides the drug and 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. This is an investigational study. Ruxolitinib is FDA approved and commercially available for the treatment of myelofibrosis (MF). Giving ruxolitinib to patients with CLL is investigational. The study doctor can explain how the study drug is designed to work. Up to 60 participants will enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02131584

Contact Investigators or Research Sites near you

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Zeev Estrov, MD

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