Description:
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously
treated chronic lymphocytic leukemia.
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
Drug | Synonyms | Arms |
---|
ACP-196 | | ACP-196 |
ibrutinib | | ibrutinib |
Purpose
This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously
treated chronic lymphocytic leukemia.
Trial Arms
Name | Type | Description | Interventions |
---|
ACP-196 | Experimental | acalabrutinib 100 mg BID (Arm A; N=250) | |
ibrutinib | Active Comparator | ibrutinib 420 mg QD (Arm B; N=250) | |
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
August 30, 2021