CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)
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 (1000mg 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 lymphectomy
             alone

          -  Positive hepatitis serology (HBV, HCV) or positive HIV or Human T Cell Leukemia Virus
             (HTLV) testing

          -  Patients with active infection requiring systemic treatment