Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

This study is designed to evaluate PFS endpoint for acalabrutinib 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

Keywords

Chronic Lymphocytic Leukemia Leukemia Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell ACP-196 ibrutinib acalabrutinib

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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.

You CAN'T join if...

  • 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.

Locations

  • Los Angeles California 90095 United States
  • La Jolla California 92093 United States
  • Los Angeles California 90017 United States
  • Orange California 92868 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Acerta Pharma BV
ID
NCT02477696
Phase
Phase 3
Study Type
Interventional
Last Updated