Clinical trial NCT02071225 (phase 2, status: completed)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: bendamustine, obinutuzumab
SMILES: ClCCN(CCCl)P1(=O)NCCCO1
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