Clinical trial NCT02970318 (phase 3, status: active, not recruiting)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: acalabrutinib (acp-196), rituximab, idelalisib, bendamustine
SMILES: CC#CC(=O)N1CCC[C@H]1C1=NC(=C2N1C=CN=C2N)C1=CC=C(C=C1)C(=O)NC1=CC=CC=N1, ClCCN(CCCl)P1(=O)NCCCO1, [H][C@@](CC)(NC1=NC=NC2=C1N=CN2)C1=NC2=CC=CC(F)=C2C(=O)N1C1=CC=CC=C1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ≥ 18 years of age.

          -  ECOG performance status of 0 to 2.

          -  Received ≥ 1 prior systemic therapies for CLL.

          -  Diagnosis of CLL - CD-20 positive, and meeting published criteria (Hallek, 2008).

          -  Active disease meeting ≥ 1 of the IWCLL 2008 criteria for requiring treatment.

          -  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 ≥ 50,000 cells/μL or ≥ 30,000 cells/μL in subjects with documented
                  bone marrow involvement, and without transfusion support 7 days before
                  assessment.

               -  AST and ALT ≤ 2.0 x upper limit of normal

               -  Total bilirubin ≤ 1.5 x ULN.

               -  Estimated creatinine clearance of ≥ 30 mL/min

        Exclusion Criteria:

          -  Known prolymphocytic leukemia or history of, or currently suspected, Richter's
             syndrome. Known CNS lymphoma or leukemia.

          -  Prior exposure to a BCL-2 inhibitor or B-cell receptor inhibitor.

          -  Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura.

          -  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.

          -  Major surgery within 30 days of first dose of study drug.

          -  Prior malignancy, except for adequately treated lentigo maligna melanoma,
             non-melanomatous skin cancer, carcinoma in situ or other malignancy treated with no
             evidence of active disease > 2 years before Screening and at low risk for recurrence.

          -  Significant cardiovascular disease within 6 months of screening.

          -  Known history of infection with HIV, or any uncontrolled active systemic infection.

          -  Active CMV infection.

          -  Serologic status reflecting active hepatitis B or C infection.

          -  History of or ongoing drug-induced pneumonitis.

          -  Malabsorption syndrome, or other condition that would impair absorption of oral study
             medication.

          -  Received a live virus vaccination within 28 days of first dose of study drug.

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

          -  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.