Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
Trial ID or NCT#
NCT02477696
Status
NOT RECRUITING
Purpose
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
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
Eligibility Criteria
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
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:
- * Absolute neutrophil count (ANC) ≥ 750 cells/μL or ≥ 500 cells/μL in participants 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. Participants with transfusion-dependent thrombocytopenia are excluded. * Serum aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT)/serum glutamic-pyruvic transaminase (SGPT) ≤ 3.0 x upper limit of normal (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 B-cell receptor (BCR) inhibitor or a B-cell lymphoma-2 (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 human immunodeficiency virus (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 cytochrome P450 3A (CYP3A) inhibitor/inducer.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
View on ClinicalTrials.gov
