Clinical trial NCT02242942 (phase 3, status: active, not recruiting)
Conditions: lymphocytic leukemia, chronic
ICD codes: C91.11, C91.12, C91.10
Drugs: chlorambucil, venetoclax, obinutuzumab
SMILES: OC(=O)CCCC1=CC=C(C=C1)N(CCCl)CCCl, CC1(C)CCC(CN2CCN(CC2)C2=CC=C(C(=O)NS(=O)(=O)C3=CC=C(NCC4CCOCC4)C(=C3)[N+]([O-])=O)C(OC3=CN=C4NC=CC4=C3)=C2)=C(C1)C1=CC=C(Cl)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Documented previously untreated CLL according to the International Workshop on Chronic
             Lymphocytic Leukemia (IWCLL) criteria

          -  CLL requiring treatment according to IWCLL criteria

          -  Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 6

          -  Adequate marrow function independent of growth factor or transfusion support within 2
             weeks of screening as per protocol, unless cytopenia is due to marrow involvement of
             CLL

          -  Adequate liver function

          -  Life expectancy > 6 months

          -  Agreement to use highly effective contraceptive methods per protocol

        Exclusion Criteria:

          -  Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation
             or pro-lymphocytic leukemia)

          -  Known central nervous system involvement

          -  Participants with a history of confirmed progressive multifocal leukoencephalopathy
             (PML)

          -  An individual organ/ system impairment score of 4 as assessed by the CIRS definition
             limiting the ability to receive the treatment regimen of this trial with the exception
             of eyes, ears, nose, throat organ system

          -  Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia

          -  Inadequate renal function

          -  History of prior malignancy, except for conditions as listed in the protocol if
             participants have recovered from the acute side effects incurred as a result of
             previous therapy

          -  Use of investigational agents or concurrent anti-cancer treatment within the last 4
             weeks of registration

          -  Participants with active bacterial, viral, or fungal infection requiring systemic
             treatment within the last two months prior to registration

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies or known sensitivity or allergy to murine products

          -  Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the
             excipients

          -  Pregnant women and nursing mothers

          -  Positive test results for chronic hepatitis B virus (HBV) infection (defined as
             positive hepatitis B surface antigen [HBsAg] serology) or positive test result for
             hepatitis C (hepatitis C virus [HCV] antibody serology testing)

          -  Participants with known infection with human immunodeficiency virus (HIV) or human
             T-cell leukemia virus-1 (HTLV-1)

          -  Requires the use of warfarin, marcumar, or phenprocoumon

          -  Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or
             inducers within 7 days prior to the first dose of study drug