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Trial record 12 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide in Chronic Lymphocytic Leukemia (CLL) Patients With Residual Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00632359
Recruitment Status : Completed
First Posted : March 10, 2008
Last Update Posted : October 15, 2015
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Drug: Lenalidomide Phase 2

Detailed Description:

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.

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.

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Lenalidomide in Patients With Chronic Lymphocytic Leukemia and Residual Disease After Chemotherapy - RV-CLL-PI-0270
Study Start Date : February 2008
Actual Primary Completion Date : October 2015

Arm Intervention/treatment
Experimental: Lenalidomide
Lenalidomide 10 mg daily given for 12 months.
Drug: Lenalidomide
10 mg daily given for 12 months
Other Name: Revlimid

Primary Outcome Measures :
  1. Time to Progression [ Time Frame: From baseline to disease progression (continual reassessments 12 months+) ]
    Time from the start of study drug therapy to the first documentation of disease progression.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00632359

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
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Principal Investigator: Alessandra Ferrajoli, M.D, M.D. Anderson Cancer Center

Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00632359     History of Changes
Other Study ID Numbers: 2007-0213
NCI-2012-01690 ( Registry Identifier: NCI CTRP )
First Posted: March 10, 2008    Key Record Dates
Last Update Posted: October 15, 2015
Last Verified: October 2015
Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents