Lenalidomide and Obinutuzumab in Treating Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Condition: Recurrent Chronic Lymphocytic Leukemia; Recurrent Small Lymphocytic Lymphoma; Refractory Chronic Lymphocytic Leukemia; Refractory Small Lymphocytic Lymphoma
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Recurrence
Intervention: Lenalidomide; Obinutuzumab
Intervention description: Given PO; Given IV
Intervention MeSH terms: Lenalidomide; Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well lenalidomide and obinutuzumab work in treating patients
      with chronic lymphocytic leukemia or small lymphocytic lymphoma that has come back
      (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such
      as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing
      the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal
      antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and
      spread. Giving lenalidomide and obinutuzumab may work better in treating patients with
      chronic lymphocytic leukemia or small lymphocytic lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to understand and to provide voluntarily informed consent

          -  Have documented chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
             according to National Cancer Institute (NCI) criteria

          -  Recurrent or refractory disease according to NCI criteria

          -  Patient are eligible if they have received one or more prior treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Life expectancy > 6 months

          -  Serum creatinine less or equal to 2 mg/dl

          -  Total bilirubin less or equal to 2 mg/dl

          -  Alanine aminotransferase (ALT)/serum glutamate pyruvate transaminase (SGPT) less or
             equal to two times the upper normal limit

          -  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

          -  No prior history of myelodysplastic syndrome or other myeloid malignancy

          -  All participants must be registered into the mandatory Revlimid Risk Evaluation and
             Mitigation Strategy (REMS) program, and be willing and able to comply with the
             requirements of the Revlimid REMS

          -  Females of childbearing potential (FCBP) must have a negative serum and/or urine
             pregnancy test with a sensitive of at least 50 mIU/mL within 10-14 days and again
             within 24 hours prior to prescribe lenalidomide for cycle 1 (prescriptions must be
             filled within 7 days as required by Revlimid REMS) and must either commit to continued
             abstinence 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; FCBP must also agree to
             ongoing pregnancy testing; men must agree to use a latex condom during sexual contact
             with a FCBP even if they have had a successful vasectomy

        Exclusion Criteria:

          -  Known sensitivity to lenalidomide or other thalidomide derivatives or anti cluster of
             differentiation (CD)20

          -  Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)

          -  Known history of infection with human immunodeficiency virus (HIV) or human T cell
             leukemia virus 1 (HTLV-1)

          -  Serologic status reflecting active hepatitis B or C; patients with hepatitis B (HBV)
             antibody positive but who have positivity for hepatitis B surface antigen (HBsAg) or
             anti hepatitis B core antibody (anti-HBc) and patients who are positive for
             anti-hepatitis C (HCV) will need to have a negative polymerase chain reaction (PCR)
             (viral HBV deoxyribonucleic acid [DNA] or HCV ribonucleic acid [RNA]) result prior to
             enrollment; those who are HBsAg positive or HBV DNA positive and those who are
             positive for HCV (RNA) will be excluded

          -  Pregnant or breast feeding females

          -  History of tuberculosis treated within the last five years or recent exposure to
             tuberculosis

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             places the subject unacceptable risk if he/she were to participate to the study

          -  Patients with a recent history of deep vein thrombosis or pulmonary embolus, in the
             six months prior to enrollment are not eligible for this study