The goal of this clinical research study is to learn if Revlimid (lenalidomide) can help to
reduce the level of leukemia in your body. The safety of this drug will also be studied.
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
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.
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.
1. Patients should have completed their chemotherapy 3 months prior to start of
treatment with lenalidomide and not more than 9 months prior to treatment initiation.
2. Patients with CLL/Small Lymphocytic Lymphoma (SLL) that achieve a complete or stable
partial remission after combination of chemotherapy. Patients in complete remission
need to have documentation of residual disease by immunophenotyping and/or PCR
3. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) status of
4. Adequate renal and hepatic function (creatinine equal to or less than 2mg/dL - total
bilirubin equal to or less than 2).
5. Females of childbearing potential (FCBP). A female of childbearing potential is a
sexually mature woman who: 1) has not undergone a hysterectomy or bilateral
oophorectomy; 2) or has not been naturally postmenopausal for at least 24 consecutive
months (has NOT had menses at any time in the preceding 24 consecutive months).
6. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at
least 50 mIU/mL within 10-14 days prior to and again within 24 hours of starting
lenalidomide and must either commit to continued abstinence from heterosexual
intercourse or begin TWO acceptable methods of birth control; one highly effective
and one additional effective method AT THE SAME TIME at least 28 days before starting
7. FCBP must also agree to ongoing pregnancy testing weekly for the first four weeks and
then every 28 days while on therapy and at discontinuation of treatment.
8. Men must agree to use a latex condom during sexual contact with a FCBP even if they
have had a successful vasectomy. All patients must be counseled at a minimum of every
28 days about pregnancy precautions and risks of fetal exposure.
9. Age 18 and older.
10. Signed, written IRB-approved informed consent.
1. Known sensitivity to lenalidomide or thalidomide or it's derivatives
2. Known positivity for HIV or active hepatitis B or C.
3. Pregnant or breast feeding females. Lactating females must agree not to breast feed
while taking lenalidomide.
4. History of tuberculosis within the last five years or recent exposure to tuberculosis
equal to or less than 6 months.
5. Any serious medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject from signing the informed consent form.
6. Any condition, including the presence of laboratory abnormalities, which places the
subject at unacceptable risk if he/she were to participate in the study or confounds
the ability to interpret data from the study.
7. Use of any other experimental drug or therapy within 28 days of baseline.
8. Concurrent use of other anti-cancer agents or treatments