A Phase II Study of Lenalidomide as Initial Treatment of Patients With Chronic Lymphocytic Leukemia Age 65 or Older - RV-CLL-PI-0188
The Study Drug:
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.
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 each day for 28 days. Twenty-eight (28) days is
considered 1 cycle. The dose and schedule of lenalidomide may be adjusted up or down,
depending on how the disease responds and the side effects you may experience. Swallow
lenalidomide capsules whole with water at the same time each day. Do not break, chew or open
the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the
same day. If you miss taking your dose for the entire day, take your regular dose the next
scheduled day (do NOT take double your regular dose to make up for the missed dose).
Allopurinol will be prescribed for you during the first 14 days of treatment. This
medication is taken by mouth and will help protect your kidney function.
During this study, you will have blood (about 1 tablespoon each) drawn every other week
until the best dose of lenalidomide has been found. Blood tests (about 1 tablespoon each)
may be done more often if the dose of medication needs to be changed or if you experience
intolerable side effects. Women who are able to have children must have a negative urine or
blood (less than 1 teaspoon) pregnancy test 10 - 14 days and 24 hours before starting
lenalidomide therapy, even if they have not had a menstrual period due to treatment of the
disease or had as little as one menstrual period in the past 24 months. If you have regular
or no menstrual cycles, you will then have pregnancy tests every week for the first 4 weeks,
then every 4 weeks while taking lenalidomide, again when you have been taken off of
lenalidomide therapy, and then 28 days after you have stopped taking lenalidomide. If you
have irregular menstrual cycles, you will have pregnancy tests every week for the first 4
weeks, then every 2 weeks while taking lenalidomide, again when you have been taken off of
lenalidomide therapy, and then 14 days and 28 days after you have stopped taking
lenalidomide. Every month for the first 3 months, then at Months 6, 9, 12, and 15 you will
have a physical exam to see how you are doing. After the 15-month visit, you will have a
physical exam every 6 months.
After the first 3 months, and then every 6 months after that (unless your study doctor does
not think it is necessary), you will have a bone marrow biopsy and aspirate performed to
check the status of the disease.
Length of Study:
You may stay on this study for as long as you are benefitting. You will be taken off this
study early if the disease gets worse or intolerable side effects occur.
This is an investigational study. Lenalidomide is FDA approved and commercially available.
Lenalidomide is approved for the treatment of patients with transfusion-dependent anemia due
to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5
abnormality with or without other chromosome abnormalities. Lenalidomide is also approved
in combination with dexamethasone for the treatment of patients with multiple myeloma that
have received at least one prior therapy. Its use in this study, for this disease, is
investigational. Up to 60 patients will take part in this study. All will be enrolled at M.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
ORR defined as number of participants with best response of Complete or Partial response out total number of participants using the NCI Working Group criteria for response. Response assessed after 3 cycles, 6 cycles and yearly thereafter.
Following 3, 6, and 12 cycles
Alessandra Ferrajoli, M.D.
M.D. Anderson Cancer Center
United States: Food and Drug Administration
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