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Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)
Not Recruiting
Trial ID: NCT02477696
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
Stanford Investigator(s)
Caroline Berube
Clinical Associate Professor, Medicine - Hematology
Rondeep Brar
Clinical Associate Professor, Medicine - Hematology
David Iberri
Clinical Assistant Professor, Medicine - Hematology
Eligibility
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.
Intervention(s):
drug: ibrutinib
drug: Acalabrutinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061