CLL11: A Study of Obinutuzumab (RO5072759 [GA101]) With Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 2)
Condition: Lymphocytic Leukemia, Chronic
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: obinutuzumab; rituximab; chlorambucil
Intervention description: 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).; 375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6.; Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle
Intervention MeSH terms: Rituximab; Obinutuzumab; Chlorambucil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 787.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, randomized, 3-arm study will evaluate the efficacy and safety of
      (obinutuzumab) RO5072759 in combination with chlorambucil as compared to rituximab plus
      chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic
      leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles
      of either RO5072759 (1000 mg intravenous (iv) infusion, on days 1, 8 and 15 of cycle 1 and
      day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or
      rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil,
      or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for
      disease-progression and safety will be at least 5 years. In the US, this trial is
      sponsored/managed by Genentech.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults >/=18 years

          -  Documented Cluster of Differentiation Antigen 20 (CD20) + B-Cell Chronic Lymphocytic
             Lymphoma (B-CLL)

          -  Previously untreated Chronic Lymphocytic Leukemia (CLL) requiring treatment according
             to the National Cancer Institute (NCI) criteria

          -  Total Cumulative Illness Rating Scale (CIRS) > 6 and/or creatinine clearance < 70
             ml/min.

        Exclusion Criteria:

          -  Prior CLL therapy

          -  Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
             transformation)

          -  History of other malignancy unless the malignancy has been in remission without
             treatment for >/=2 years prior to enrolment, and except for carcinoma in situ of the
             cervix, basal or squamous cell skin cancer, surgically treated low-grade prostate
             cancer, or ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone

          -  Positive hepatitis serology (HBV, HCV) or positive HIV or Human T-Cell Leukemia Virus
             (HTLV) testing

          -  Patients with active infection requiring systemic treatment.