Lenalidomide in Patients With Chronic Lymphocytic Leukemia Older Than 65 Years of Age
Condition: Chronic Lymphocytic Leukemia; Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: lenalidomide
Intervention description: Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg.
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: No
Keywords: Lenalidomide; CLL; 09-045

Summary:

      The purpose of this study is to:

      Determine the likelihood that lenalidomide will adequately control the disease for at least
      one year.

      Lenalidomide is a drug that alters the immune system and it may also interfere with the
      development of tiny blood vessels that help support tumor growth. Therefore, in theory, it
      may reduce or prevent the growth of cancer cells. 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 patients with multiple myeloma (MM) who have
      received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being
      tested in a variety of cancer conditions.

      In this case it is considered experimental. The lenalidomide being administered in this study
      is not a commercially marketed product. Although it is expected to be very similar in safety
      and activity to the commercially marketed drug, it is possible that some differences may
      exist. Because this is not a commercially marketed drug, lenalidomide can only be
      administered to patients enrolled in this clinical trial and may only be administered under
      the direction of physicians who are investigators in this clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with either previously untreated or treated disease must have either
             intermediate or high-risk chronic lymphocytic leukemia as defined by the three-stage
             Rai system. Patients with Rai intermediate risk disease should meet the criteria for
             active disease as outlined by the NCI Working Group guidelines (including weight loss,
             fatigue, fevers, evidence of progressive marrow failure, splenomegaly, progressive
             lymphadenopathy, or progressive lymphocytosis with a rapid doubling time)(49).

          -  MSKCC pathologist must confirm patient's disease.

          -  To be considered CLL the patient must have an absolute lymphocytosis in the blood of
             at least 5,000 lymphocytes per microliter, or bone marrow lymphocytosis greater than
             or equal to 30% of all nucleated cells

          -  Immunophenotypic (or immunohistochemical) analysis of the malignant lymphocytes should
             demonstrate that the cells are B-cells. Typically these cells should also express CD5
             and CD23. It is recognized that an occasional patient with CLL may have a slightly
             aberrant immunophenotype. All such cases need to be reviewed with the principal
             investigator prior to being registered for the study. Patients with small lymphocytic
             lymphoma (CLL type) will be eligible for this study.

          -  Age ≥ 65 years of age.

          -  Karnofsky performance status ≥ 50%

          -  ANC ≥ 0.8 and platelet count ≥ 30,000

          -  Total creatinine ≤ 2.0mg/dl or creatinine clearance ≥ 30ml/min.

          -  Total bilirubin ≤ 3.0 mg/dL (not attributable to autoimmune hemolytic anemia).

          -  Signed informed consent, which indicates the investigational nature of this study, is
             required.

          -  No patient may be entered onto the study without consultation with the principal
             investigator or his designee.

          -  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.

        Exclusion Criteria:

          -  Patients with significant active infections.

          -  Men should use effective contraception.

          -  Patients known positive for HIV or with active infection from hepatitis, A, B, or C.

          -  Concomitant chemotherapy or radiotherapy while on protocol.

          -  Evidence of laboratory TLS by Cairo-Bishop Definition of Tumor Lysis Syndrome.

          -  History of thromboembolic disease within the past 6 months, regardless of
             anti-coagulation.

          -  Myocardial infarction within 6 months prior to enrollment, or New York Hospital
             Association (NYHA) Class III or IV heart failure , uncontrolled angina, severe
             uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia
             or active conduction system abnormalities.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Any prior use of lenalidomide.