Last updated on May 2016

ACE-CL-007: Study of Obinutuzumab + Chlorambucil, ACP-196 + Obinutuzumab, and ACP-196 Monotherapy in Subjects With Previously Untreated CLL


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Lymphocytic Leukemia | Chronic
  • Age: 18 Years
  • Gender: Male or Female

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
  • Men and women ≥ 18 years of age.
  • ECOG performance status of 0 to 2.
  • Diagnosis of CLL.
  • Must have ≥ 1 of the following high-risk prognostic factors:
    • Presence of 17p del by central laboratory.
    • Presence of 11q del by central laboratory.
  • Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
  • Must have received ≥ 1 prior therapies for CLL.
  • Meet the following laboratory parameters:
    • ANC ≥ 750 cells/µL or ≥ 500 cells/µL in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
    • Platelet count ≥ 30,000 cells/µL without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded
    • Serum AST/SGOT and ALT/SGPT ≤ 3.0 x ULN.
    • Total bilirubin ≤ 1.5 x ULN.
    • Estimated creatinine clearance ≥ 30 mL/min.
Exclusion Criteria:
  • Known CNS lymphoma or leukemia.
  • Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  • Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura
  • Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor.
  • Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
  • Prior radio- or toxin-conjugated antibody therapy.
  • Prior allogeneic stem cell or autologous transplant.
  • Major surgery within 4 weeks before first dose of study drug.
  • Prior malignancy, except for adequately treated lentigo maligna melanoma, non-melanomatous skin cancer, in situ cervical carcinoma or other malignancy treated with no evidence of active disease > 3 years before Screening and at low risk for recurrence.
  • Significant cardiovascular disease within 6 months of Screening.
  • Known history of infection with HIV.
  • History of stroke or intracranial hemorrhage within 6 months before randomization.
  • History of bleeding diathesis.
  • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
  • Requires treatment with a strong CYP3A inhibitor/inducer.

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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