A Study of Obinutuzumab + Bendamustine (BG) in Participants With Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Bendamustine; Obinutuzumab
Intervention description: Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6.; Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.
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: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, open-label, multicenter study to evaluate the safety and efficacy of BG
      induction therapy in participants with previously untreated CLL. The anticipated time on
      study treatment is 24 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must satisfy one of the criteria for treatment initiation, as outlined in
             the iwCLL NCI-WG guidelines. The criteria include: (a) Evidence of progressive marrow
             failure as manifested by the development of, or worsening of, anemia and/or
             thrombocytopenia, (b) Massive (i.e., greater than or equal to [>=] 6 centimeters [cm]
             below the left costal margin) or progressive or symptomatic splenomegaly, (c) Massive
             nodes (i.e., >= 10 cm in longest diameter) or progressive or symptomatic
             lymphadenopathy, (d) Progressive lymphocytosis with an increase of greater than (>) 50
             percent (%) over a 2-month period or lymphocyte doubling time (LDT) of less than (<) 6
             months, (e) Autoimmune anemia and/or thrombocytopenia that is poorly responsive to
             corticosteroids or other standard therapy, (f) Constitutional symptoms, defined as any
             one or more of the following disease-related symptoms or signs: unintentional weight
             loss of >=10% within the previous 6 months, significant fatigue (i.e., Eastern
             Cooperative Oncology Group Performance Status [ECOG PS] of 2 or worse or the inability
             to work or perform usual activities), fevers higher than 100.5 degrees Fahrenheit
             (°F)/38.0 degrees Celsius (°C) for >= 2 weeks without other evidence of infection, or
             night sweats for >1 month without evidence of infection

          -  Absolute neutrophil count (ANC) >=1.5 × 10^9 per liter (/L) and platelets >=75 ×
             10^9/L unless cytopenia is caused by the underlying disease, i.e., no evidence of
             additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone
             marrow)

          -  Life expectancy >6 months

          -  ECOG PS of 0, 1, or 2

          -  Willing to use acceptable contraceptive measures as defined by the protocol during and
             at least for 6 months (male participants) or 12 months (female participants) after the
             last dose of study drug

        Exclusion Criteria:

          -  Pregnant or lactating, or intending to become pregnant during the study: Women who are
             not postmenopausal (>=12 months of non-therapy-induced amenorrhea) or surgically
             sterile must have a negative serum pregnancy test result within 14 days prior to
             initiation of study drug

          -  Participants who have received previous CLL therapy, including investigational
             therapies

          -  Transformation of CLL to aggressive non-Hodgkin's lymphoma (Richter's transformation)

          -  Inadequate renal function

          -  Inadequate liver function: National Cancer Institute Common Terminology Criteria for
             Adverse Events (NCI CTCAE) Grade 3 liver function tests (aspartate aminotransferase
             [AST] or alanine aminotransferase [ALT] >5× upper limit of normal [ULN] for >2 weeks;
             bilirubin >3× ULN) unless due to underlying disease

          -  History of other malignancy, which could affect compliance with the protocol or
             interpretation of results

          -  Participants with active bacterial, viral, or fungal infection requiring systemic
             treatment

          -  Participants with known infection with human immunodeficiency virus (HIV) or human
             T-cell leukemia virus 1 (HTLV-1)

          -  Positive hepatitis serology: (a) Participants with positive serology for hepatitis B,
             defined as positivity for hepatitis B surface antigen (HBsAg), or participants who are
             HBsAg negative but are hepatitis B core antibody (anti-HBc) positive, (b) Participants
             positive for anti-HBc, but with negative hepatitis B Virus (HBV) deoxyribonucleic acid
             (DNA), will be considered for inclusion by the Medical Monitor on a case-by-case basis
             in order to ensure feasibility of monthly DNA testing and availability of appropriate
             care in case of hepatitis B reactivation, (c) Participants with positive serology for
             hepatitis C (HCV) unless HCV (by ribonucleic acid [RNA]) is confirmed negative

          -  History of severe allergic or anaphylactic reactions to monoclonal antibodies

          -  Evidence of significant, uncontrolled concomitant diseases that could affect
             compliance with the protocol or interpretation of results, including significant
             cardiovascular disease (such as New York Heart Association Class III or IV cardiac
             disease, myocardial infarction within the previous 6 months, unstable arrhythmias, or
             unstable angina) or pulmonary disease (including obstructive pulmonary disease and
             history of symptomatic bronchospasm)

          -  Vaccination with a live vaccine a minimum of 30 days prior to study treatment

          -  Use of investigational agents of any kind within 30 days before study treatment