Acalabrutinib: Participants will receive oral acalabrutinib as stated in arm description.
Ibrutinib: Participants will receive oral ibrutinib as stated in arm description.
Study summary
This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
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.
Primary outcome measure(s)
Progression-free Survival (PFS) Based on Independent Review Committee (IRC) Assessment — Baseline (Days -28 to -1) through 55.2 months (maximum observed duration) The PFS is defined as the time from date of randomization to the date of first IRC-assessed PD or death due to any cause, whichever occurred first. PD (per International Workshop on Chronic Lymphocytic Leukemia \[iwCLL\] 2008 criteria): Lymphocytes \>= 50% increase over baseline, or \>= 50% increase in lymphadenopathy/hepatomegaly/splenomegaly, or \>= 50% platelets or \> 2 g/dL hemoglobin decreases from baseline secondary to chronic lymphocytic leukemia (CLL). The PFS is assessed using the Kaplan-Meier method.
Trial sites (130)
Facility
City
Region
Status
Research Site
Phoenix
Arizona
Research Site
Anaheim
California
Research Site
Berkeley
California
Research Site
Duarte
California
Research Site
La Jolla
California
Research Site
Los Angeles
California
Research Site
Palo Alto
California
Research Site
Santa Rosa
California
Research Site
Jacksonville
Florida
Research Site
Tampa
Florida
Research Site
Athens
Georgia
Research Site
Harvey
Illinois
Research Site
Peoria
Illinois
Research Site
Wichita
Kansas
Research Site
Minneapolis
Minnesota
Research Site
Rochester
Minnesota
Research Site
Billings
Montana
Research Site
Hackensack
New Jersey
Research Site
Lake Success
New York
Research Site
New Hyde Park
New York
Research Site
New York
New York
Research Site
New York
New York
Research Site
New York
New York
Research Site
Durham
North Carolina
Research Site
Columbus
Ohio
Research Site
Philadelphia
Pennsylvania
Research Site
Houston
Texas
Research Site
Round Rock
Texas
Research Site
Charlottesville
Virginia
Research Site
Tacoma
Washington
Research Site
Northwest WA
Wisconsin
Research Site
Darlinghurst
Australia
Research Site
Frankston
Australia
Research Site
Melbourne
Australia
Research Site
St Leonards
Australia
Research Site
Waratah NSW
Australia
Research Site
Wollongong
Australia
Research Site
Bruges
Belgium
Research Site
Brussels
Belgium
Research Site
Ghent
Belgium
+ 90 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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