Phase II Nilotinib With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML)
The goal of this clinical research study is to learn if an experimental agent, AMN107 (nilotinib), can help to control Chronic Myelogenous Leukemia (CML) in chronic phase. The safety of this experimental agent will also be studied.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Oral Nilotinib|
- PCR ratios of Bcr-Abl/Abl (molecular CR) after 12 months of therapy with Nilotinib [ Time Frame: 12 months ] [ Designated as safety issue: No ]Complete Hematologic Remission (CHR) - normalization for at least 4 weeks of bone marrow (less than 5% blasts) and peripheral blood with WBC < 10 x 109/L and no peripheral blasts, promyelocytes or myelocytes. This is in addition to disappearance of all signs and symptoms of the disease. Molecular response = PCR ratio < 0.05%, or PCR negative
- Complete Cytogenetic Response [ Time Frame: June 2009 ] [ Designated as safety issue: No ]
Complete hematologic remission classified according to suppression of Philadelphia chromosome (Ph) by cytogenetics or i FISH
- No cytogenetic response - Ph positive 100% of pretreatment value
- Minor cytogenetic response - Ph positive 35-90% of pretreatment value
- Partial cytogenetic response - Ph positive 1-34% of pretreatment value
- Complete cytogenetic response - Ph positive 0% Major cytogenetic response = complete + partial (Ph positive <35%)
|Study Start Date:||June 2005|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
400 mg orally twice daily
400 mg orally twice daily
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 another 18 months. After that, you may have the blood tests repeated as often as the doctor thinks it is needed. 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 about 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, the study staff will recommend that you have physical exams once 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129740
|Contact: Jorge Cortes, MD||713-794-5783|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Jorge Cortes, MD 713-794-5783|
|Principal Investigator:||Jorge Cortes, MD||M.D. Anderson Cancer Center|