Summary:
Clinical Research Study for Adults with Chronic Phase CML
Chronic myeloid leukemia (CML) is the fourth most common type of leukemia occurring in adults.CML occurs more often in older adults than in children, but it can occur in people of any age. Many people with CML may live for months or even years without showing any symptoms; however, most people may respond to treatment better when it is started as early as possible.
What is chronic phase CML?
Chronic myeloid leukemia (CML) is a rare form of leukemia, which is cancer of the blood. CML begins in the blood-forming cells of the bone marrow, which is the soft interior of large bones, such as the skull, shoulder blades, and ribs.
In patients with CML, cancer eventually spreads to other parts of the body.CML progresses over three different stages — chronic phase, accelerated phase, and blast phase. The chronic phase is the earliest of these stages.
What treatment options are available for CML?
If you’ve been newly diagnosed with chronic myeloid leukemia (CML), it’s important to choose the treatment option that is right for you. There are several treatment options available, including targeted therapies, such as bosutinib and imatinib, which are the medications used in the BFORE study. Bosutinib has shown promise in recent clinical trials and has been successful in treating patients whose leukemia has not responded to other types of treatment.
What is the BFORE clinical research study?
The purpose of the BFORE study is to evaluate the safety and effectiveness of an investigational medication called bosutinib as a first treatment option (known as first-line therapy) for chronic phase CML. Although it has shown to be effective in a previous clinical study, bosutinib is considered investigational in the BFORE study because, it is not currently approved as a first-line therapy
In the BFORE study, bosutinib will be compared to another medication, called imatinib, which is commonly given as a first-line therapy to patients with CML.
What will happen during the BFORE study?
If you are eligible to participate, you will be assigned to receive either bosutinib or imatinib, which will be provided free of charge for the duration of your participation in the study. You will have an equal chance of receiving either medication. You will know what medication you are taking.
You will take bosutinib or imatinib for 1 year during what is called the core treatment phase. After the core treatment phase, you will enter an extension phase for 4 years. The study will last about 5 years.
During the study, you will be required to:
- Visit the study clinic for study-related tests and procedures; 10study visits in the first year with additional blood testing at your local medical center, followed by 4 visits in the second and third years and 2 visits in each of the following years.
- Undergo a procedure to remove a sample from your bone marrow several times during the study.
- Complete questionnaires about your health.
Who can participate in the study?
You may be able to join the study if you:
- Are at least 18 years old
- Have been diagnosed with chronic phase CML within the past 6 months
- Have not received treatment for CML other than with medication used to control blood counts (for example hydroxyurea or anagrelide)
There are other eligibility requirements that you must meet to participate. The study staff can discuss these in greater detail.
What are the potential risks and benefits?
Everyone who participates in a research study must first complete a screening visit. During the screening visit, the study doctor will explain the study details and the potential risks and benefits of participation in the study.
The information learned from the study may help improve treatment options for people with CML in the future.
Study participation is voluntary. If you choose to participate, you may leave the study at any time for any reason. The study doctor and staff will be available to help you throughout the study and to address any questions you may have.