An Expanded Access, Open-Label Study of Obinutuzumab (GA101) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Genentech, Inc.
- Enrollment
- 20
- Locations
- 19
- Primary Endpoint
- Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Obinutuzumab + Chlorambucil
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
Intervention: Obinutuzumab (Drug)
Obinutuzumab + Chlorambucil
Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
Intervention: Chlorambucil (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Received Obinutuzumab and Chlorambucil in the Study
Time Frame: Cycles 1 to 6 (28-day cycles)
Number of participants who received obinutuzumab and chlorambucil in the study are presented in the below table.
Secondary Outcomes
- Number of Participants With Adverse Events (AEs), AEs of Grade 3 and Above Severity, AEs of Special Interest (AESI), AEs Leading to Obinutuzumab Discontinuation or Dose Delays, Serious Adverse Events (SAEs), and Death(Up to 28 days after the last dose of study drug (up to 7 months from Day 1))
- Number of Participants With Objective Response(Up to end of treatment or premature discontinuation from study (up to 7 months from Day 1))