Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Oral Nilotinib
Nilotinib is a drug that is designed to block a protein that is responsible for the
development of CML.
If you are found to be eligible to take part in this study, you will take 2-4 nilotinib
capsules or tablets by mouth 2 times a day (4-8 capsules or tablets a day total) every day,
at least 8 hours apart. Nilotinib should be taken each morning and evening with a large
glass of water. The study medication will be given to you every 3 - 12 months. You will
also be given a "pill diary" to write down when (day and time) you take the drug. You will
also write in the diary any side effects you may experience. You should bring the diary,
any unused capsules or tablets, and empty containers of nilotinib with you to every visit to
the study doctor. Any unused supplies must be returned at the end of the study.
Every 1-4 weeks during the first 4 weeks of the study, you will have around 2 teaspoons of
blood drawn for routine blood tests. The blood tests will then be repeated every 4-8 weeks
(or more often if your doctor feels it is necessary) until you have been on study for 6
months, then every 3 to 6 months for as long as you are on the study. A bone marrow sample
will also be taken every 3-4 months for the first year and then every 6-12 months in the 2nd
year, then every 2-3 years for as long as you are on the study to check on the status of the
disease. Additionally, blood (about ½ tablespoon) will be drawn or a bone marrow sample will
be collected every 3-4 months for the first year and then every 6-12 months until 2 years,
and then one time a year for as long as you are on the study to check on the status of the
disease. However, if you are in complete remission after Year 2, your doctor will decide
when you will have a bone marrow aspiration. But you will still have blood drawn (about ½
tablespoon) every 1 - 3 years to check the status of your disease. An ECG will be repeated
around Day 5, and then at about 6 weeks and about 3 months.
You will be asked to visit the doctor for a physical exam and to have vital signs measured
periodically. These visits will be scheduled at least every 3 to 4 months the first year.
After the first year, physical exams will be at least every year. The visits may be
scheduled more often depending on the status of the disease.
Treatment may be continued for up to 8-10 years or as long as the doctor feels it is
necessary to control the leukemia. If the disease gets worse or you experience any
intolerable side effects, you will be taken off the study and your doctor will discuss other
treatment options with you.
This is an investigational study. Nilotinib is FDA approved. A total of 150 patients will
take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
PCR ratios of Bcr-Abl/Abl (molecular CR) after 12 months of therapy with Nilotinib
Jorge Cortes, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|