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

Running, not enrolling · Phase 3

Conditions studied: Chronic Lymphocytic Leukemia

In brief

This study is designed to evaluate progression-free survival (PFS) endpoint for acalabrutinib versus (vs) ibrutinib in previously treated chronic lymphocytic leukemia.

Key facts

Study ID

NCT02477696

Run by

Acerta Pharma BV

People needed

533

Starts

2015-07-28

Expected to finish

2028-01-03

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Anaheim, California, United States
• Research Site — Berkeley, California, United States
• Research Site — Duarte, California, United States
• Research Site — La Jolla, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Palo Alto, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Athens, Georgia, United States
• Research Site — Harvey, Illinois, United States
• Research Site — Peoria, Illinois, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Minneapolis, Minnesota, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Billings, Montana, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — Lake Success, New York, United States
• Research Site — New Hyde Park, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — New York, New York, United States
• Research Site — Durham, North Carolina, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.