A Study Evaluating the Efficacy of Obinutuzumab and Bendamustine Treatment in Participants With Refractory or Relapsed Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: bendamustine; obinutuzumab
Intervention description: 70 milligrams per square meter (mg/m^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.; 1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.
Intervention MeSH terms: Bendamustine Hydrochloride; Obinutuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial was designed to evaluate the efficacy of obinutuzumab and bendamustine
      treatment in participants with refractory or relapsed chronic lymphocytic leukemia (CLL).
      Participants receive up to six 28-day cycles of treatment. Treatment consists of intravenous
      (IV) administration of obinutuzumab and bendamustine. Treatment time is expected to last 6
      months, and participant follow-up will last 2 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 years or older

          -  Diagnosed CD20+ B- chronic lymphocytic leukemia (CLL) according to National Cancer
             Institute (NCI) criteria

          -  Active disease meeting at least 1 of the International Workshop on CLL (IWCLL) 2008
             criteria for treatment

          -  Refractory CLL (i.e. treatment failure or progression during treatment or within 6
             months after the last treatment) or relapse CLL (i.e. participants who met criteria
             for CR or PR, but progressed beyond 6 months post-treatment)

          -  At least 1 prior purine analogue or bendamustine containing therapy

          -  Life expectancy greater than (>) 6 months

          -  Use of effective contraception as described in the study protocol

        Exclusion Criteria:

          -  Prior Alogenic Bone Marrow Transplant

          -  Greater than or equal to (>/=) 3 previous lines of chemotherapy and/or immunotherapy
             for the CLL

          -  Previous obinutuzumab-containing regimen

          -  Treatment failure or progression within 6 months of bendamustine-containing regimen

          -  Transformation of CLL to aggressive non-Hodgkin lymphoma (NHL; Richter's
             transformation) Patients with prolymphocytic transformation cannot entry the study
             either

          -  Active haemolytic anaemia

          -  Inadequate liver function

          -  History of other malignancy which could affect compliance with the protocol or
             interpretation of results. Patients with a history of malignancy that has been treated
             but not with curative intent will be excluded, unless the malignancy has been in
             remission without treatment for >/= 2 years prior to enrolment. Patients with a
             history of adequately treated carcinoma in situ of the cervix; basal or squamous cell
             skin cancer; low grade, early stage localized prostate cancer treated surgically with
             curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated
             with lumpectomy alone with curative intent are eligible

          -  Evidence of significant, uncontrolled concomitant diseases that could affect
             compliance with the protocol or interpretation of results, including significant
             cardiovascular disease or pulmonary disease

          -  Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for
             diagnosis

          -  Regular treatment with corticosteroids during the 4 weeks prior to study start, unless
             administered for another condition at a dose equivalent to less than or equal to (</=)
             30 milligrams per day (mg/day) prednisone

          -  Known active infection or any infection requiring treatment with IV antibiotics or
             hospitalization within 4 weeks prior to study start

          -  Patients with HIV, human T cell leukemia virus 1 (HTLV-1), hepatitis B or hepatitis C

          -  Pregnancy or breast-feeding

          -  Vaccination with a live vaccine within 4 weeks prior to baseline visit

          -  Receipt of any other study drug within 4 weeks prior to study start