Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

This study is to determine the clinical minimum residual disease (MRD) response with the combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma.

Cancer (Oncology), Cancer (Oncology) - Leukemia, Cancer (Oncology) - Lymphoma
John Pagel, MD, PhD

Swedish Cancer Institute

Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CLL/SLL that meets IWCLL diagnostic criteria (Hallek 2008), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
  • Measurable nodal disease by computed tomography (CT)
  • Adequate hepatic, and renal function
  • Adequate hematologic function

    • absolute neutrophil count >750/µL
    • platelet count >30,000 /μL
    • hemoglobin >8.0 g/dL

Exclusion Criteria:

  • Any prior therapy used for treatment of CLL/SLL
  • Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for TLS
(206) 215-3086