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9L-11-4: An Open-Label, Multicenter, Randomized Phase II Trial Comparing the Efficacy, Safety and Pharmacokinetics of Ga101 1000 Mg Versus 2000 Mg In Patients With Previously Untreated Chronic Lymphocytic Leukemia

Description

This open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (RO5072759; GA101) 1000 mg versus 2000 mg in participants with previously untreated CLL. Participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of each subsequent cycle up to 8 cycles.

Phase

Phase 2 - takes the treatment one step further, assessing the activity of a particular therapy in a disease, often building upon leads from the Phase I trial. While patients are generally required to be previously untreated, participation in a Phase II trial doesn't usually preclude the patient from getting the standard treatment after they've received the investigational agent. At best they are allowed to get a new drug they wouldn't be able to get otherwise that may turn out to be better for their disease.

Inclusion and Exclusion Criteria

  • Confirmed diagnosis of CD20-positive B-cell CLL (per International Workshop on Chronic Lymphocytic Leukemia [IWCLL] guidelines)
  • Rai Stage III/IV or Binet Stage C disease, or Rai Stage I/II or Binet Stage B disease that requires treatment according to IWCLL guidelines
  • No previous treatment for CLL chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP); prior use of steroids for AIHA or ITP is allowed
  • Eastern Cooperative Oncology Group performance status of 0, 1 or 2

  • Confirmed diagnosis of Transformation of CLL to aggressive B-cell malignancy
  • History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
  • Evidence of severe, uncontrolled concomitant disease
  • Known active infection or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks before the start of Cycle 1
  • Seropositive for human immunodeficiency virus (HIV)
  • Positive for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology)
  • Positive for hepatitis C (hepatitis C virus [HCV] antibody serology testing)
  • Pregnant or lactating women
  • Concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions

Sites

  • California

    • Unknown facility, Pasadena, California, 91750
    • Unknown facility, La Jolla, California, 92093
  • Arizona

    • Unknown facility, Tucson, Arizona, 85704
    • Unknown facility, Tucson, Arizona, 85715
  • Colorado

    • Unknown facility, Colorado Springs, Colorado, 80907
    • Unknown facility, Lone Tree, Colorado, 80124
    • Unknown facility, Denver, Colorado, 80218
    • Unknown facility, Aurora, Colorado, 80012
    • Unknown facility, Parker, Colorado, 80138
  • Oregon

    • Unknown facility, Portland, Oregon, 97225
  • Washington

    • Unknown facility, Vancouver, Washington, 98684
    • Unknown facility, Yakima, Washington, 98902
  • Idaho

    • Unknown facility, Coeur D'Alene, Idaho, 83814
    • Unknown facility, Post Falls, Idaho, 83854
  • Oklahoma

    • Unknown facility, Oklahoma City, Oklahoma, 73142
  • Texas

    • Unknown facility, Fort Worth, Texas, 76177
    • Unknown facility, Dallas, Texas, 75230
    • Unknown facility, Dallas, Texas, 75231
  • Kentucky

    • Unknown facility, Paducah, Kentucky, 42001
  • Indiana

    • Unknown facility, Lafayette, Indiana, 47905
    • Unknown facility, Goshen, Indiana, 46526
  • Alabama

    • Unknown facility, Birmingham, Alabama, 35249
  • Ohio

    • Unknown facility, Kettering, Ohio, 45429
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