Combination of Lenalidomide and Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (CLL/SLL)
The Study Drugs:
Lenalidomide is designed to change the body's immune system. It 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.
Ofatumumab is designed to bind to the surface of a type of white blood cells called B-cells
and destroy them. The cancer cells in B-CLL/SLL are B-cells.
Study Drug Administration:
Each cycle is 28 days.
If you are found to be eligible to take part in this study, you will receive ofatumumab by
vein over 4 hours at the following times:
- On Days 1, 8, 15, and 22 of Cycle 1.
- On Day 1 of Cycles 2-6.
- On Day 1 of every even cycle beginning Cycle 8 (Cycles 8,10,12, and so on).
Beginning on Day 9 of Cycle 1, you will take lenalidomide by mouth every day.
Swallow lenalidomide capsules whole with a glass of 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). If you take more than the prescribed dose of lenalidomide you should seek
emergency medical care if needed and contact study staff right away. Any unused lenalidomide
should be returned as instructed through the RevAssist® program.
On Days 1-14 of Cycle 1, you will take allopurinol to help prevent side effects. You will
take this by mouth with 1 glass of water 1 time a day. If the doctor thinks it is needed,
you will continue to take allopurinol.
If the doctor thinks it is needed, you may take aspirin or low molecular weight heparin to
help prevent blood clots.
If the doctor thinks it is needed, you may take medicine to help prevent return of hepatitis
You should drink at least 8-10 cups of water each day for the first 14 days of Cycle 1 (
this includes the 1 with medications).
One (1) time a week for the first 5 weeks, then 1 time every 2 weeks (if the dose of
lenalidomide has been changed), and then every 4 weeks, blood (about 2-3 teaspoons) will be
drawn for routine tests.
On Day 28 of Cycles 3, 7, 13, 19, and 23:
- You will have a physical exam, including measurement of your vital signs.
- Your performance status will be recorded
- Urine will be collected for routine tests.
- You will have a bone marrow aspiration and biopsy to check the status of the disease.
If you continue past 23 cycles, once every 6-12 cycles (+ 14 days):
- Blood (about 2-3 teaspoons) will be drawn for routine tests.
- If the doctor thinks it is needed, you will have a bone marrow biopsy and aspirate to
check the status of the disease .
If the doctor thinks it is needed, extra blood (about 2-3 teaspoons) will be drawn for
routine tests and at any time during the study.
If you have a type of hepatitis B called HBcAb, you are at risk of having hepatitis B
infection during treatment with ofatumumab. Every 2 months, blood (about 1/2 teaspoon each
time) will be drawn to check for hepatitis B infection.
If you are a woman who is able to become pregnant, you will have blood (about 1 teaspoon) or
urine pregnancy tests 1 time a week for the first 28 days of the study, then every 28 days
while on study, when you stop the study, and at 28 days after off study.
If you are a woman who is able to become pregnant and your menstrual cycles are irregular,
you will have blood (about 1 teaspoon) or urine pregnancy tests 1 time a week for the first
28 days, then every 14 days while on study, when you stop the study, and at 14 and 28 days
after off study.
Length of Study:
You will be on study for about 2 years. You will be taken off study early if you have
intolerable side effects or the disease gets worse.
If the doctor thinks you are benefiting, you may be able to continue taking lenalidomide for
as long as you are benefitting. If you continue, you will follow the same schedule of dosing
and study visit schedule.
About 6 months after you go off study, blood (about 1 teaspoon) will be drawn for routine
tests. You will not need to come to M. D. Anderson for this blood draw, it can be performed
by your local doctor.
The study staff will call you every 3 months from then on unless you begin a new treatment
and ask you how you are doing. This phone call will take about 2-3 minutes.
After you are off study, if you have hepatitis B, blood (about 1/2 teaspoon each time) will
be drawn every 2-3 months up to 6 months after the last dose of ofatumumab.
This is an investigational study. Lenalidomide is FDA approved for the treatment of
multiple myeloma and some myelodysplastic syndromes. Ofatumumab is FDA approved and
commercially available for the treatment of CLL. The combination of lenalidomide and
ofatumumab to treat CLL or SLL is investigational.
Up to 36 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
Responses assessed after 3, 6, 12, 18 and 24 cycles (each cycle is 28 days) and every 6-12 months as clinically indicated.
Alessandra Ferrajoli, MD
UT MD Anderson Cancer Center
United States: Food and Drug Administration
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