{
    "info": {
        "nct_id": "NCT02980731",
        "official_title": "Open-Label, Single Arm, Phase 3b, Multi-Center Study Evaluating the Impact of Venetoclax on the Quality of Life of Relapsed/Refractory Subjects With Chronic Lymphocytic Leukemia (CLL) (VENICE II)",
        "inclusion_criteria": "* Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2\n* Participant has relapsed/refractory disease (received at least one prior therapy)\n* Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines and:\n\n  * has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines\n  * has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)\n  * with or without 17p deletion or TP53 mutation\n  * may have been previously treated with a prior B-cell receptor inhibitor therapy\n* Adequate bone marrow function\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 99 Years",
        "exclusion_criteria": "* Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL)\n* Participant has previously received venetoclax\n* History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:\n\n  * adequately treated in situ carcinoma of the cervix uteri\n  * adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin\n  * previous malignancy confined and surgically resected (or treated with other modalities) with curative intent\n* Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids\n* Prior allogeneic stem cell transplant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance score of ≤ 2",
                    "criterion": "ECOG performance score",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has relapsed/refractory disease (received at least one prior therapy)",
            "criterions": [
                {
                    "exact_snippets": "Participant has relapsed/refractory disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received at least one prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "therapy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of CLL that meets published 2008 Modified International Workshop on CLL National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines and:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of CLL",
                    "criterion": "chronic lymphocytic leukemia (CLL)",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "meets published 2008 Modified International Workshop on CLL National Cancer Institute - Working Group (IWCLL NCI-WG) Guidelines",
                    "criterion": "IWCLL NCI-WG Guidelines compliance",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* has an indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines",
            "criterions": [
                {
                    "exact_snippets": "indication for treatment according to the 2008 Modified IWCLL NCI-WG Guidelines",
                    "criterion": "indication for treatment",
                    "requirements": [
                        {
                            "requirement_type": "guideline",
                            "expected_value": "2008 Modified IWCLL NCI-WG Guidelines"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* has clinically measurable disease (lymphocytosis > 5 × 10^9/L and/or palpable and measurable nodes by physical exam and/or organomegaly assessed by physical exam)",
            "criterions": [
                {
                    "exact_snippets": "lymphocytosis > 5 × 10^9/L",
                    "criterion": "lymphocytosis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "palpable and measurable nodes by physical exam",
                    "criterion": "nodes",
                    "requirements": [
                        {
                            "requirement_type": "palpability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organomegaly assessed by physical exam",
                    "criterion": "organomegaly",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* with or without 17p deletion or TP53 mutation",
            "criterions": [
                {
                    "exact_snippets": "17p deletion",
                    "criterion": "17p deletion",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "absence",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "TP53 mutation",
                    "criterion": "TP53 mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": {
                                "operator": "=",
                                "value": 0,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "absence",
                            "expected_value": {
                                "operator": "=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* may have been previously treated with a prior B-cell receptor inhibitor therapy",
            "criterions": [
                {
                    "exact_snippets": "may have been previously treated with a prior B-cell receptor inhibitor therapy",
                    "criterion": "prior B-cell receptor inhibitor therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate bone marrow function",
            "criterions": [
                {
                    "exact_snippets": "Adequate bone marrow function",
                    "criterion": "bone marrow function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 99 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 99 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 99,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Participant has developed Richter's transformation or Prolymphocytic leukemia (PLL)",
            "criterions": [
                {
                    "exact_snippets": "Participant has developed Richter's transformation",
                    "criterion": "Richter's transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Participant has developed ... Prolymphocytic leukemia (PLL)",
                    "criterion": "Prolymphocytic leukemia (PLL)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Participant has previously received venetoclax",
            "criterions": [
                {
                    "exact_snippets": "Participant has previously received venetoclax",
                    "criterion": "venetoclax treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of active malignancies other than CLL within the past 2 years prior to first dose of venetoclax, with the exception of:",
            "criterions": [
                {
                    "exact_snippets": "History of active malignancies other than CLL within the past 2 years",
                    "criterion": "active malignancies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequately treated in situ carcinoma of the cervix uteri",
            "criterions": [
                {
                    "exact_snippets": "adequately treated in situ carcinoma of the cervix uteri",
                    "criterion": "in situ carcinoma of the cervix uteri",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin",
            "criterions": [
                {
                    "exact_snippets": "adequately treated basal cell carcinoma",
                    "criterion": "basal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "adequately treated ... localized squamous cell carcinoma of the skin",
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        },
                        {
                            "requirement_type": "localization",
                            "expected_value": "localized"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* previous malignancy confined and surgically resected (or treated with other modalities) with curative intent",
            "criterions": [
                {
                    "exact_snippets": "previous malignancy confined",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "confined"
                        }
                    ]
                },
                {
                    "exact_snippets": "previous malignancy ... surgically resected (or treated with other modalities) with curative intent",
                    "criterion": "previous malignancy",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "surgically resected or treated with other modalities with curative intent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening), including autoimmune hemolytic anemia (AIHA) or idiopathic thrombocytopenic purpura (ITP), despite low dose corticosteroids",
            "criterions": [
                {
                    "exact_snippets": "Active and uncontrolled autoimmune cytopenias (within 2 weeks prior to screening)",
                    "criterion": "autoimmune cytopenias",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 weeks prior to screening"
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune hemolytic anemia (AIHA)",
                    "criterion": "autoimmune hemolytic anemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "idiopathic thrombocytopenic purpura (ITP)",
                    "criterion": "idiopathic thrombocytopenic purpura",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "despite low dose corticosteroids",
                    "criterion": "response to corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "despite low dose corticosteroids"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior allogeneic stem cell transplant",
            "criterions": [
                {
                    "exact_snippets": "Prior allogeneic stem cell transplant",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "prior",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}