Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia
Lenalidomide is designed to change the body's immune system and may also interfere with the
development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
may decrease or prevent the growth of cancer cells.
Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. You will have a complete medical history and physical exam. Blood (between 2-4
teaspoons) and urine will be collected for routine tests. For patients taking Coumadin,
blood will be collected (2-4 teaspoons) to measure anticoagulation in order to closely
monitor your clotting ability for the purpose of adjusting your Coumadin dose, if necessary.
This blood test is called an INR (International Standard Method to follow anticoagulation).
You will have a bone marrow biopsy and aspirate. To collect a bone marrow biopsy and
aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow
and bone is withdrawn through a large needle. These two collections are performed as one
single procedure. You also will have an electrocardiogram (ECG - a test that measures the
electrical activity of the heart). Women who are able to have children must have a negative
urine pregnancy test.
If you are found to be eligible to take part in this study, you will take lenalidomide by
mouth every morning at about the same time for 28 days. This is considered 1 cycle. The
dose and schedule of lenalidomide may be adjusted up or down depending on how your disease
responds and the side effects you experience.
During this study, you will have blood samples (about 1 tablespoon each) taken once a week
during the Cycle 1 until a stable dose of lenalidomide has been found. You will then have
about 1 tablespoon of blood drawn every 2 weeks for an additional cycle and then once a
month from then on while you are on study. Blood tests (about 1 tablespoon each) may be done
more frequently if the dose of medication needs to be adjusted or if you experience side
effects. Every month during the first 3 months, you will have a physical exam to see how you
are doing. You will have a physical exam every 3 months from then on. After the first 3
months of treatment, a bone marrow biopsy and aspirate is going to be collected to evaluate
your response to the treatment. In participants who continue to receive treatment, a bone
marrow biopsy and aspiration are going to be repeated every 6 months during the first year,
and then once a year after that while on study.
You will be required to return to M. D. Anderson at least once a month, for the first 3
months, and until a stable dose of lenalidomide has been established. Following this, you
will be required to return at least every 3 months while taking the medication . Women who
are able to have children must have a negative pregnancy test 10-14 days before the start of
therapy and a repeat pregnancy test 24 hours before the start of lenalidomide, every week
for the first 4 weeks, every 4 weeks if they have regular menstruation, every 2 weeks if
their periods are irregular, and 30 days after they stop taking lenalidomide. Only if you
have had a hysterectomy or no menstrual periods for at least 24 months in a row, will you
not be required to have these pregnancy tests and use birth control.
You may continue to receive treatment as long as your disease is responding and no
intolerable side effects occur. You will be taken off study if the disease gets worse or
intolerable side effects occur.
This is an investigational study. Lenalidomide is approved by the Food and Drug
Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS)
and in combination with dexamethasone for multiple myeloma. Lenalidomide use in chronic
lymphocytic leukemia is considered experimental. Up to 45 patients may take part in this
study. All will be enrolled at M. D. Anderson.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Number of Patients in Overall Response Categories
Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.
Evaluated after three 28-day cycles of lenalidomide.
Alessandra Ferrajoli, MD
UT M.D. Anderson Cancer Center
United States: Food and Drug Administration
|UT MD Anderson Cancer Center||Houston, Texas 77030|