An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Obinutuzumab; Chlorambucil
Intervention MeSH terms: Obinutuzumab; Chlorambucil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, single-arm, expanded access treatment study designed to
      provide obinutuzumab to patients with previously untreated Chronic Lymphocytic Leukemia (CLL)
      in combination with chlorambucil and to evaluate the safety and efficacy of obinutuzumab
      administered in combination with chlorambucil. This study will enroll patients with
      previously untreated CD20-positive CLL requiring treatment according to the IWCLL guidelines
      (Hallek et al 2008), as assessed by the investigator.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CD20-positive CLL (per IWCLL guidelines, Hallek et al 2008)

          -  Previously untreated CLL requiring treatment according to the IWCLL guidelines (Hallek
             et al 2008), as assessed by the investigator

          -  Adequate baseline bone marrow function unless it due to underlying CLL disease No
             previous treatment for CLL by chemotherapy, radiotherapy, or immunotherapy

          -  Patients who are not appropriate to receive more intensive chemotherapy in the
             judgment of the investigator

          -  Life expectancy of > 6 months

        Exclusion Criteria:

          -  Treatment with any other investigational agent or participation in another clinical
             trial within 28 days prior to the start of Cycle 1

          -  Transformation of CLL to aggressive B-cell malignancy History of severe allergic or
             anaphylactic reactions to monoclonal antibody therapy

          -  Known hypersensitivity to chlorambucil or any of its excipients

          -  History of other malignancy that could affect compliance with the protocol or
             interpretation of results Known active bacterial, viral, fungal, mycobacterial, or
             other infection (excluding fungal infections of nail beds) or any major episode of
             infection requiring treatment with IV antibiotics or hospitalization (related to the
             completion of the course of antibiotics) within 4 weeks before the start of Cycle 1

          -  Major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis

          -  Known infection with human immunodeficiency virus (HIV) or Human T-Cell Leukemia Virus
             1 (HTLV-1) seropositive status

          -  Positive hepatitis serology

          -  Women who are pregnant or lactating

          -  Fertile men or women of childbearing potential unless 1) surgically sterile or 2)
             using an adequate measure of contraception such as oral contraceptives, intrauterine
             device, or barrier method of contraception in conjunction with spermicidal jelly

          -  Effective contraception is required while receiving obinutuzumab. For women, effective
             contraception is required to continue for >= 12 months after the last dose of
             obinutuzumab. For men, effective contraception is required to continue for 6 months
             after the last dose of chlorambucil treatment.

          -  Vaccination with a live vaccine a minimum of 28 days prior to the start of Cycle 1