Expired Study
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Charlottesville, Virginia 22908


Purpose:

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


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. - 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.


NCT ID:

NCT02477696


Primary Contact:

Study Director
Acerta Clinical Trials
1-888-292-9613


Backup Contact:

N/A


Location Contact:

Charlottesville, Virginia 22908
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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