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

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Acerta Pharma BV
• Treatments: Acalabrutinib

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.