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

Trial ID or NCT#

NCT02477696

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - Men and women ≥ 18 years of age.
  2. - ECOG performance status of 0 to 2.
  3. - Diagnosis of CLL.
  4. - Must have ≥ 1 of the following high-risk prognostic factors:
  5. - Presence of 17p del by central laboratory.
  6. - Presence of 11q del by central laboratory.
  7. - Active disease meeting ≥ 1 of the following IWCLL 2008 criteria for requiring treatment
  8. - Must have received ≥ 1 prior therapies for CLL.
  9. - Meet the following laboratory parameters:
  10. - 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.
  11. - Platelet count ≥ 30,000 cells/μL without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
  12. - Serum AST/SGOT and ALT/SGPT ≤ 3.0 x ULN.
  13. - Total bilirubin ≤ 1.5 x ULN.
  14. - Estimated creatinine clearance ≥ 30 mL/min.
Exclusion Criteria:
  1. - Known CNS lymphoma or leukemia.
  2. - Known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome.
  3. - Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenia purpura.
  4. - Prior exposure to ibrutinib or to a BCR inhibitor or a BCL-2 inhibitor.
  5. - Received any chemotherapy, external beam radiation therapy, anticancer antibodies, or investigational drug within 30 days before first dose of study drug.
  6. - Prior radio- or toxin-conjugated antibody therapy.
  7. - Prior allogeneic stem cell or autologous transplant.
  8. - Major surgery within 4 weeks before first dose of study drug.
  9. - 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.
  10. - Significant cardiovascular disease within 6 months of screening.
  11. - Known history of infection with HIV.
  12. - History of stroke or intracranial hemorrhage within 6 months before randomization.
  13. - History of bleeding diathesis.
  14. - Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists within 7 days of first dose of study drug.
  15. - Requires treatment with a strong CYP3A inhibitor/inducer.
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Investigator(s)

Caroline Berube
Caroline Berube
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Rondeep Brar
Rondeep Brar
Hematologist-Oncologist
Clinical Associate Professor, Medicine - Hematology
Steven Coutre
David Iberri
David Iberri
Hematologist-Oncologist
Clinical Assistant Professor, Medicine - Hematology

Contact us to find out if this trial is right for you.

Contact

CCTO
650-498-7061

View on ClinicalTrials.gov