Clinical Trials /

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL

NCT02477696

Description:

This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously treated chronic lymphocytic leukemia.

Related Conditions:
  • Chronic Lymphocytic Leukemia
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Study of ACP-196 Versus <span class="go-doc-concept go-doc-intervention">Ibrutinib</span> in Previously Treated Subjects With High Risk <span class="go-doc-concept go-doc-disease">Chronic Lymphocytic Leukemia</span>

Title

  • Brief Title: Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
  • Official Title: A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase 3 Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia
  • Clinical Trial IDs

    NCT ID: NCT02477696

    ORG ID: ACE-CL-006

    Trial Conditions

    Chronic Lymphocytic Leukemia

    Trial Interventions

    Drug Synonyms Arms
    ACP-196 ACP-196
    ibrutinib ibrutinib

    Trial Purpose

    This study is designed to evaluate PFS endpoint for ACE-196 vs ibrutinib in previously
    treated chronic lymphocytic leukemia.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    ACP-196 Experimental ACP-196 will be orally administered until disease progression or unacceptable toxicity. ACP-196
    ibrutinib Active Comparator Ibrutinib will be orally administered until disease progression or unacceptable toxicity. ibrutinib

    Eligibility Criteria

    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.

    - Measurable nodal disease by CT.

    - Meet the following laboratory parameters:

    - ANC 750 cells/L or 500 cells/L in subjects with documented bone marrow
    involvement, and independent of growth factor support 7 days before assessment.

    - Platelet count 30,000 cells/L 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 2.5 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.

    - Currently active clinically significant cardiovascular disease within 6 months before
    first dose with study drug.

    - 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 28 days of first dose of study drug.

    - Requires treatment with a strong CYP3A4 inhibitor/inducer.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression-free survival in Arm A compared to Arm B

    Secondary Outcome Measures

    Incidence of treatment-emergent Grade 3 infections in Arm A versus Arm B

    Incidence of Richter's transformation in Arm A versus Arm B

    Incidence of Atrial fibrillation in Arm A versus Arm B

    Overall survival in Arm A versus Arm B

    Trial Keywords