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A Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy - RV-CLL-PI-0270


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Lymphocytic Leukemia

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Trial Information

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
experience.

If you are a woman who is able to have children, you must wear gloves if you touch the
lenalidomide capsules.

Study Visits:

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.

Pregnancy Testing:

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.

Long-Term Follow-Up:

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
performed:

- 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
the disease.

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.


Inclusion Criteria:



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
molecular testing.

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

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
taking lenalidomide.

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.

Exclusion Criteria:

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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to Progression

Outcome Description:

Time from the start of study drug therapy to the first documentation of disease progression.

Outcome Time Frame:

From baseline to disease progression (continual reassessments 12 months+)

Safety Issue:

No

Principal Investigator

Alessandra Ferrajoli, M.D,

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

2007-0213

NCT ID:

NCT00632359

Start Date:

February 2008

Completion Date:

August 2014

Related Keywords:

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

Name

Location

The University of Texas M.D. Anderson Cancer CenterHouston, Texas