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

Not Recruiting

Trial ID: NCT02477696


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
Caroline Berube

Clinical Associate Professor, Medicine - Hematology

Rondeep Brar
Rondeep Brar

Clinical Associate Professor, Medicine - Hematology

David Iberri
David Iberri

Clinical Assistant Professor, Medicine - Hematology


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

   - 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

      - 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

   - 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

   - 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.


drug: ibrutinib

drug: Acalabrutinib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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