Lenalidomide in Combination With Rituximab as Treatment for Patients With Relapsed Chronic Lymphocytic Leukemia - RV-CLL-PI-0292
The Study Drugs:
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 the growth of cancer cells.
Rituximab is designed to bind to a protein, called CD20, that is on the surface of the
leukemia cells, allowing the leukemia cells to be destroyed by the immune system.
If you are found to be eligible to take part in this study, you will receive rituximab
through a needle into your vein 1 time a week in Cycle 1. You will not receive rituximab
during Cycle 2, but you will continue to take lenalidomide.You will receive a dose of
rituximab by vein on Day 1 of Cycles 3-12. Your first dose of rituximab will be given over
6-8 hours. If the first dose is well tolerated, you may receive the next doses over 2-4
hours. If the doctor thinks it is needed, the next doses may given over a longer time.
On Day 9 of Cycle 1, you will begin taking lenalidomide by mouth once a day. You will then
take lenalidomide once a day, every day.
The dose and schedule of lenalidomide may change depending on the side effects you may
experience. You should swallow lenalidomide capsules whole with a glass (8 ounces) 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.
You need to tell the study staff before you start or stop taking any drug.
Each study cycle is 4 weeks.
Once a week during the first 5 weeks, blood (about 1 tablespoon) will be drawn for routine
After the first 5 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.
At the end of Cycles 3, 6, and 12, you will have a bone marrow biopsy and aspirate to check
the status of the disease. Blood (about 1 tablespoon) will be drawn for routine blood tests.
If you stay on study past 12 cycles, once every 6 cycles (Cycles 18, 24, 30, and so on), you
will have a bone marrow biopsy and aspirate to check the status of the disease. Blood (about
1 tablespoon) will be drawn for routine blood tests.
Blood (about 1 tablespoon) will be drawn more often if the dose of lenalidomide needs to be
changed or if you experience intolerable side effects.
Women who are able to become pregnant must have a negative urine or blood (less than 1
teaspoon) pregnancy test 10-14 days and 24 hours before the first dose of lenalidomide, even
if they have not had a menstrual period due to treatment of the disease or had only 1
menstrual period in the past 24 months.
If you have regular or no menstrual cycles, you will then have a urine or blood (less than 1
teaspoon) pregnancy test every week for the first 4 weeks, then every 4 weeks while taking
lenalidomide, again as soon as 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 urine or blood (less than 1 teaspoon)
pregnancy test every week for the first 4 weeks, then every 2 weeks while taking
lenalidomide, again as soon as you have been taken off of lenalidomide therapy, and then at
14 days and 28 days after you have stopped taking lenalidomide.
Length of Study:
You will be on study treatment for about 1 year. You will be taken off study early if you
experience intolerable side effects or the disease gets worse.
If the doctor thinks you are benefiting, you may be able to continue taking the study
treatment. If you continue, you will follow the same schedule of dosing and study visit
This is an investigational study. Lenalidomide and rituximab are FDA approved and
commercially available. Lenalidomide is approved for the treatment of multiple myeloma and
some myelodysplastic syndromes. Rituximab is approved for the treatment of chronic
lymphoproliferative disorders and non-Hodgkin's lymphoma. The combination of these drugs to
treat CLL and SLL is investigational.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Patient Response
Efficacy + toxicity evaluated first at completion of cycle 6 (28 day cycle) through 1 year
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|