Trial Search Results
Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Subjects With High Risk CLL
This research study is evaluating an investigational drug, called ACP-196, in comparison with a drug called ibrutinib as a possible treatment for patients with CLL. The purpose of this study, which involves research, is to determine if an experimental drug: ACP-196 is safe and effective in the treatment of this disease.
Stanford is currently not accepting patients for this trial.
Acerta Pharma BV
- Drug: ACP-196
- Drug: ibrutinib
- 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:
- 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.
- 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 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
- 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.
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study