Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

Elevate CLL R/R: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk Chronic Lymphocytic Leukemia

Protocol: OSU-15095

Full Title

A Randomized, Multicenter, Open-Label, Non-Inferiority, Phase III Study of ACP-196 Versus Ibrutinib in Previously Treated Subjects with High Risk Chronic Lymphocytic Leukemia

Purpose

This study is designed to evaluate PFS endpoint for acalabrutinib vs ibrutinib in previously

treated chronic lymphocytic leukemia.

Are you eligible?

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:

ANC ≥ 750 cells/μL or ≥ 500 cells/μL in subjects 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. Subjects with transfusion-dependent thrombocytopenia are excluded.

Serum AST/SGOT and ALT/SGPT ≤ 3.0 x 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 BCR inhibitor or a 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 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 CYP3A inhibitor/inducer.

Chronic Lymphocytic Leukemia Leukemia