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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00632359
First received: March 3, 2008
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Chronic Lymphocytic Leukemia
Drug: Lenalidomide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: From baseline to disease progression (continual reassessments 12 months+) ] [ Designated as safety issue: No ]
    Time from the start of study drug therapy to the first documentation of disease progression.


Estimated Enrollment: 52
Study Start Date: February 2008
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lenalidomide
Lenalidomide 10 mg daily given for 12 months.
Drug: Lenalidomide
10 mg daily given for 12 months
Other Name: Revlimid

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632359

Contacts
Contact: Alessandra Ferrajoli, M.D. 713-792-2063 aferrajo@mdanderson.org

Locations
United States, Texas
The University of Texas M.D. Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Alessandra Ferrajoli, M.D.    713-792-2063    aferrajo@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Celgene Corporation
Investigators
Principal Investigator: Alessandra Ferrajoli, M.D, M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00632359     History of Changes
Other Study ID Numbers: 2007-0213, NCI-2012-01690
Study First Received: March 3, 2008
Last Updated: April 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Chronic Lymphocytic Leukemia
CLL
Lenalidomide
Revlimid

Additional relevant MeSH terms:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Lenalidomide
Thalidomide
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on September 18, 2014