Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)
Condition: Hematologic Disorder
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Hematologic Diseases
Intervention: Lenalidomide; Influenza Vaccine; Pneumovax Vaccine
Intervention description: 5 mg/day by mouth on Monday, Wednesday and Friday for 3 months. Process repeated for up to 2 years.
If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day by mouth for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years.; Administered as injection yearly, during the fall/winter season.; Administered by injection once between month 6 and month 21. Patients, who have received the Pneumovax vaccine within last 5 years, will not receive Pneumovax vaccination.
Intervention MeSH terms: Lenalidomide; Vaccines
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hematologic Disorder; Chronic Lymphocytic Leukemia; CLL; Hypogammaglobulinemia; Impaired Response to Vaccinations; Immunoglobulins; Immune system's function; Lenalidomide; CC-5013; Revlimid; Flu vaccine; TIV; Pneumonia vaccine

Summary:

      The goal of this clinical research study is to learn if lenalidomide can increase the level
      of immunoglobulins (parts of the blood that may help to improve the immune system's function)
      and/or will improve the protective effect of the flu and pneumonia vaccines in patients with
      CLL.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic lymphocytic leukemia (CLL) patients with IgG less than 500 mg/dl with/without
             symptoms who are either untreated or previously treated, regardless of response, at
             least 6 months from prior therapy (including mAb)..

          2. Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance
             status of 0-2.

          3. Adequate renal functions as indicated by serum creatinine equal to or less than 2
             mg/dl.

          4. Adequate hepatic function indicated as total bilirubin equal to or less than 2 mg/dl
             and alanine aminotransferase (ALT) equal to or less than two times the upper limit of
             normal.

          5. Disease free of prior malignancies for 3 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 or surgery can be enrolled in the study as long as they have a
             reasonable expectation to have been cured with the treatment modality received.

          6. 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; or 2) has not been naturally postmenopausal for at least 24 consecutive
             months (i.e., has not had menses at any time in preceding 24 consecutive months)>

          7. FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least
             50 mlU/mL within 10-14 days prior to and again within 24 hours of starting
             lenalidomide 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 28 days before she starts taking lenalidomide.

          8. 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).

          9. 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.

         10. Patients must be 18 years of age or older.

         11. All study participants must be registered into the mandatory Revlimid REMS® program,
             and be willing and able to comply with the requirements of the REMS® program.

         12. Females of reproductive potential must adhere to the scheduled pregnancy testing as
             required in the Revlimid REMS® program. Able to take aspirin (81 or 325 mg) daily as
             prophylactic anticoagulation (patients intolerant to ASA may use warfarin or low
             molecular weight heparin).

        Exclusion Criteria:

          1. Known sensitivity to lenalidomide or other thalidomide derivatives.

          2. History of Guillain-Barre within 6 weeks of previous influenza vaccination.

          3. Patient on steroid therapy.

          4. Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood) or
             Richter's transformation.

          5. Known positivity for HIV or active hepatitis B or C.

          6. Pregnant or breast feeding females.

          7. History of tuberculosis treated within the last five years or recent exposure to
             tuberculosis.

          8. Any serious medical condition, laboratory abnormality or psychiatric illness that
             places the subject at unacceptable risk if he/she were to participate in the study.

          9. Patients with a recent history of deep vein thrombosis (DVT) or pulmonary embolus
             (PE), in six months prior to enrollment are not eligible for this study.

         10. Subjects who have currently active hepatic or biliary disease (with the exception of
             patients with Gilbert's syndrome).

         11. Patients with severe allergic reaction (e.g., anaphylaxis) after previous dose of any
             influenza vaccine or to a vaccine component, including egg protein.

         12. Moderate or severe acute illness with or without fever.

         13. Use of any other experimental drug or therapy within 28 days of baseline.

         14. Concurrent use of other anti-cancer agents or treatments.