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.

Lead Sponsor:

Acerta Pharma BV

Intervention(s):

  • Drug: ACP-196
  • Drug: ibrutinib

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting