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Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia

Phase 2
18 Years
Not Enrolling
Chronic Lymphocytic Leukemia, Leukemia

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Trial Information

Lenalidomide (Revlimid) in Patients With Previously Treated Chronic Lymphocytic Leukemia

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.

Before you can start treatment on this study, you will have what are called "screening
tests." These tests will help the doctor decide if you are eligible to take part in this
study. You will have a complete medical history and physical exam. Blood (between 2-4
teaspoons) and urine will be collected for routine tests. For patients taking Coumadin,
blood will be collected (2-4 teaspoons) to measure anticoagulation in order to closely
monitor your clotting ability for the purpose of adjusting your Coumadin dose, if necessary.
This blood test is called an INR (International Standard Method to follow anticoagulation).
You will have a bone marrow biopsy and aspirate. To collect a bone marrow biopsy and
aspirate, an area of the hip is numbed with anesthetic, and a small amount of bone marrow
and bone is withdrawn through a large needle. These two collections are performed as one
single procedure. You also will have an electrocardiogram (ECG - a test that measures the
electrical activity of the heart). Women who are able to have children must have a negative
urine pregnancy test.

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 for 28 days. This is considered 1 cycle. The
dose and schedule of lenalidomide may be adjusted up or down depending on how your disease
responds and the side effects you experience.

During this study, you will have blood samples (about 1 tablespoon each) taken once a week
during the Cycle 1 until a stable dose of lenalidomide has been found. You will then have
about 1 tablespoon of blood drawn every 2 weeks for an additional cycle and then once a
month from then on while you are on study. Blood tests (about 1 tablespoon each) may be done
more frequently if the dose of medication needs to be adjusted or if you experience side
effects. Every month during the first 3 months, you will have a physical exam to see how you
are doing. You will have a physical exam every 3 months from then on. After the first 3
months of treatment, a bone marrow biopsy and aspirate is going to be collected to evaluate
your response to the treatment. In participants who continue to receive treatment, a bone
marrow biopsy and aspiration are going to be repeated every 6 months during the first year,
and then once a year after that while on study.

You will be required to return to M. D. Anderson at least once a month, for the first 3
months, and until a stable dose of lenalidomide has been established. Following this, you
will be required to return at least every 3 months while taking the medication . Women who
are able to have children must have a negative pregnancy test 10-14 days before the start of
therapy and a repeat pregnancy test 24 hours before the start of lenalidomide, every week
for the first 4 weeks, every 4 weeks if they have regular menstruation, every 2 weeks if
their periods are irregular, and 30 days after they stop taking lenalidomide. Only if you
have had a hysterectomy or no menstrual periods for at least 24 months in a row, will you
not be required to have these pregnancy tests and use birth control.

You may continue to receive treatment as long as your disease is responding and no
intolerable side effects occur. You will be taken off study if the disease gets worse or
intolerable side effects occur.

This is an investigational study. Lenalidomide is approved by the Food and Drug
Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS)
and in combination with dexamethasone for multiple myeloma. Lenalidomide use in chronic
lymphocytic leukemia is considered experimental. Up to 45 patients may take part in this
study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. Patients with B-cell CLL with indications for treatment by National Cancer Institute
(NCI) Working Group Criteria, or Rai Stage III or IV or patients with CLL requiring
treatment because of any of the following: disease related symptoms, progressive
marrow failure (development or worsening of anemia and/or patients' thrombocytopenia)
progressive splenomegaly, progressive lymphoadenopathy, progressive lymphocytosis

2. Patients who have received a minimum of one prior purine analog-based chemotherapy
regimen. Prior treatment with corticosteroids, immunotherapy, monoclonal antibody or
radiation therapy is permitted. All previous cancer therapy, including radiation,
hormonal therapy and surgery must have been discontinued 2 weeks prior to treatment
in this study. Any cytotoxic chemotherapy must be discontinued 4 weeks prior to
treatment in this study.

3. Age more or equal to 18 years (CLL is not observed in patients less than 18 years of

4. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
status 0-2.

5. Adequate renal function indicated by serum creatinine less or equal to 2 and adequate
hepatic function indicated as total bilirubin less or equal to 2 times the upper
limit of normal.

6. Understand and sign Informed Consent after the investigational nature, study design,
risks and benefits of the study have been explained.

7. Females of childbearing potential (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 method and one additional effective method AT THE SAME
TIME, at least 4 weeks before she starts taking lenalidomide. FCBP must also agree to
ongoing pregnancy testing.

8. Continued from #7. Men must agree to use a condom during sexual contact with a female
of child bearing potential 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. Continued from #8. A female of childbearing potential is a sexually mature woman who:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at
any time in the preceding 24 consecutive months).

10. Disease free of prior malignancies for 5 years with exception of currently treated
basal cell, squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
or breast. Patients with malignancies with indolent behavior such as prostate cancer
treated with radiation can be enrolled in the study as long as they have a reasonable
expectation to have been cured with treatment modality received.

Exclusion Criteria:

1. Known sensitivity to thalidomide or its derivatives

2. The development of erythema nodosum as characterized by a desquamating rash while
taking thalidomide or similar drugs.

3. Prior use of lenalidomide

4. Concurrent use of other chemotherapy agents.

5. Known positivity for Human immunodeficiency virus (HIV) or infectious hepatitis type
A, B or C.

6. Pregnant or lactating females.

7. A serious medical condition, laboratory abnormality or psychiatric illness that would
pose the subject at unacceptable risk if he/she were to participate in the study or
that would interfere with the ability of the patient to carry out the treatment
program or confine the ability to interpret the data from the study.

8. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).

9. Active cardiovascular disease as defined by the New York Heart Association class 3 or

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients in Overall Response Categories

Outcome Description:

Overall Response defined as participant had either complete response (CR) or partial response (PR) assessed after three cycles, at six months and yearly thereafter using the NCI-Working Group Criteria: Complete Response, Complete Response with Nodules, Partial Response, or No Response.

Outcome Time Frame:

Evaluated after three 28-day cycles of lenalidomide.

Safety Issue:


Principal Investigator

Alessandra Ferrajoli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

December 2005

Completion Date:

August 2009

Related Keywords:

  • Chronic Lymphocytic Leukemia
  • Leukemia
  • Chronic Lymphocytic Leukemia
  • Lenalidomide
  • Revlimid
  • CLL
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid



UT MD Anderson Cancer Center Houston, Texas  77030