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

Title

  • Brief Title: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL
  • Official Title: A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: ACE-CL-006
  • NCT ID: NCT02477696

Conditions

  • Chronic Lymphocytic Leukemia

Interventions

DrugSynonymsArms
ACP-196ACP-196
ibrutinibibrutinib

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
ACP-196Experimentalacalabrutinib 100 mg BID (Arm A; N=250)
  • ACP-196
ibrutinibActive Comparatoribrutinib 420 mg QD (Arm B; N=250)
  • 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.

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression-free survival in Arm A compared to Arm B
Time Frame:36 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence of treatment-emergent Grade ≥ 3 infections in Arm A versus Arm B
Time Frame:36 months
Safety Issue:
Description:
Measure:Incidence of Richter's transformation in Arm A versus Arm B
Time Frame:36 months
Safety Issue:
Description:
Measure:Incidence of Atrial fibrillation in Arm A versus Arm B
Time Frame:36 months
Safety Issue:
Description:
Measure:Overall survival in Arm A versus Arm B
Time Frame:36 months
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Acerta Pharma BV

Last Updated

May 20, 2021