Clinical trial NCT02611908 (phase 1, status: withdrawn)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: ibrutinib, obinutuzumab
SMILES: NC1=NC=NC2=C1C(=NN2[C@@H]1CCCN(C1)C(=O)C=C)C1=CC=C(OC2=CC=CC=C2)C=C1
Reason stopped: 
    no participants enrolled
  
Eligibility criteria:

        Inclusion Criteria:

          -  Clinical and phenotypic verification of B cell CLL or SLL and measurable disease.

          -  Prior therapy: Patients must have been receiving single agent ibrutinib therapy at the
             time of disease progression. Patient may have received other therapy in combination
             with ibrutinib earlier in the their treatment course. Prior obinutuzumab therapy is
             also permitted.

          -  Progressive disease on current single agent ibrutinib therapy (but not within the
             first 2 months of initiating ibrutinib therapy). Progression is based on 2008 iwCLL
             definition.

          -  ECOG performance status of 0-2.

          -  Adequate hematologic function.

          -  Adequate renal function.

          -  Adequate hepatic function.

        Exclusion Criteria:

          -  Known CNS lymphoma or leukemia

          -  History of Richter's or prolymphocytic transformation.

          -  Primary ibrutinib resistance, defined by progressive disease within the first 2 months
             of first initiating ibrutinib therapy.

          -  Uncontrolled autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenia purpura
             (ITP)

          -  CLL therapy, with the exception of ibrutinib within the following timeframes:

               1. Chemotherapy, external beam radiation therapy, anticancer antibodies within 30
                  days prior to the first dose of drug on this study.

               2. Corticosteroid use 20mg prednisone within 1 week prior to first dose on this
                  study.

               3. Radio- or toxin-conjugated antibody therapy within 10 weeks prior to first dose
                  on this study.

               4. Allogeneic stem cell transplant within 6 months prior to first dose on this study

          -  History of major surgery within 4 weeks prior to first dose on this study.

          -  History of prior malignancy, with the exception of adequately treated non-melanoma
             skin cancer, malignancies treated with curative intent and with no evidence of active
             disease for more than 3 years, or adequately treated cervical carcinoma in situ
             without current evidence of disease.

          -  Currently active clinically significant cardiovascular disease or history of
             myocardial infarction within 6 months of first dose.

          -  Serologic status and/or PCR testing reflecting active hepatitis B or C infection.

          -  Known history of infection with human immunodeficiency virus (HIV).

          -  Unable to swallow capsules or disease significantly affecting gastrointestinal
             function.

          -  History of stroke or intracranial hemorrhage within 6 months of first dose.

          -  Requires anticoagulation with warfarin or other Vitamin K antagonists.

          -  Requires treatment with a strong CYP 3A inhibitor.

          -  Pregnant or breast-feeding women

          -  Women of child-bearing age must obtain a pregnancy test and pregnant or breast feeding
             females

          -  Patients who are currently receiving another investigational therapy

          -  Current infection requiring parenteral antibiotics.