A Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy - RV-CLL-PI-0270
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.
Study Drug Administration:
If you are found to be eligible to take part in this study, you will take lenalidomide by
mouth every night each day for up to 12 months. You should 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 a dose, it should not be made up on another day.
The dose and schedule of lenalidomide may be changed, depending on the side effects you may
If you are a woman who is able to have children, you must wear gloves if you touch the
Once a week during the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine
tests. Blood may be drawn more often if the dose of lenalidomide needs to be changed or if
you experience side effects.
After the first 4 weeks, blood (about 1 tablespoon) will be drawn for routine tests every 2
weeks until the doctor thinks your dose of lenalidomide will not change. After this, blood
(about 1 tablespoon) will then be drawn every 4 weeks for routine tests.
On Month 4 and 12 (+14 days), you will have a physical exam and blood (about 2-3 teaspoons)
will be drawn to check the status of the disease.
On Month 4 and 12 (+14 days), and then every 3 months after that (unless your study doctor
does not think it is necessary), you will have a bone marrow biopsy and aspirate to check
the status of the disease.
If you are a woman who is able to have children, you will have blood (about 2-3 teaspoons)
or urine collected for pregnancy tests while you are on study.
If you have regular or no menstrual cycles, you will have pregnancy tests every week for the
first 4 weeks, then every 4 weeks after that. You will have a pregnancy test when you stop
taking the study drug, and then 28 days later.
If you have irregular menstrual cycles, you will have pregnancy tests every week for the
first 4 weeks, then every 2 weeks after that. You will have a pregnancy test when you stop
taking the study drug, 14 days later, and 28 days later.
Length of Study:
You will continue receiving the study drug for up to 12 months. You will continue having
study visits for as long as the disease remains stable. You will be taken off study early if
the disease gets worse or intolerable side effects occur.
Once you are off study, you will have follow-up visits every 3 months for as long as the
disease remains stable. At these visits, the following tests and procedures will be
- You will have a bone marrow biopsy and aspirate performed.
- Blood (about 2-3 teaspoons) will be drawn for routine tests and to check the status of
This is an investigational study. Lenalidomide is FDA approved and commercially available
for the treatment of patients with myelodysplastic syndrome. Lenalidomide is also approved
to be used in combination with dexamethasone for the treatment of some patients with
multiple myeloma. Its use in this study, for this disease, is investigational.
Up to 52 patients will take part in this study. All will be enrolled at MD Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to Progression
Time from the start of study drug therapy to the first documentation of disease progression.
From baseline to disease progression (continual reassessments 12 months+)
Alessandra Ferrajoli, M.D,
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|The University of Texas M.D. Anderson Cancer Center||Houston, Texas|