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Clinical Trials in the UK / NCT02477696
Active, not recruiting Phase 3

Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

NCT02477696 · tracked via the Priya Life Science UK tracker
Sponsor
Acerta Pharma BV
Phase
Phase 3
Started
2015-07-28
Last updated
2026-08-26

Condition(s) studied

Chronic Lymphocytic Leukemia

Investigational drug(s) / intervention(s)

AcalabrutinibIbrutinib

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)

Trial sites (130)

FacilityCityRegionStatus
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.

On this site

📄 Calquence (acalabrutinib) drug profile → 📄 Imbruvica (ibrutinib) drug profile →

More Acerta Pharma BV trials in the UK

Other trials for the same condition

Official registry record

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.

View NCT02477696 on ClinicalTrials.gov ↗ ← All trials in the UK