{
    "info": {
        "nct_id": "NCT01909934",
        "official_title": "A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma",
        "inclusion_criteria": "* Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy\n* Bidimensional measurable disease\n* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence\n* Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence\n* Clinical laboratory values as specified in the study protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previous treatment with brentuximab vedotin.\n* Previously received an allogeneic transplant.\n* Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).\n* Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)\n* Female participants who are lactating and breastfeeding or pregnant\n* Known human immunodeficiency virus (HIV) positive\n* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male or female participants age 18 years or older, with relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Male or female participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "inclusion",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                },
                {
                    "exact_snippets": [
                        "age 18 years or older"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 18
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "relapsed or refractory sALCL"
                    ],
                    "criterion": "sALCL",
                    "requirement_type": "status",
                    "expected_value": [
                        "relapsed",
                        "refractory"
                    ]
                },
                {
                    "exact_snippets": [
                        "previously received at least 1 multiagent chemotherapy"
                    ],
                    "criterion": "multiagent chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Bidimensional measurable disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Bidimensional measurable disease"
                    ],
                    "criterion": "disease",
                    "requirement_type": "measurability",
                    "expected_value": "bidimensional"
                }
            ]
        },
        {
            "line": "* An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1"
                    ]
                }
            ]
        },
        {
            "line": "* Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "postmenopausal for at least 1 year before the screening visit"
                    ],
                    "criterion": "menopausal status",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                },
                {
                    "exact_snippets": [
                        "surgically sterile"
                    ],
                    "criterion": "surgical sterility",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug"
                    ],
                    "criterion": "contraception methods",
                    "requirement_type": "quantity",
                    "expected_value": ">=2"
                },
                {
                    "exact_snippets": [
                        "agree to practice true abstinence"
                    ],
                    "criterion": "abstinence",
                    "requirement_type": "agreement",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence",
            "criterions": [
                {
                    "exact_snippets": [
                        "Male participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "male"
                },
                {
                    "exact_snippets": [
                        "agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "practice",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "agree to practice true abstinence"
                    ],
                    "criterion": "abstinence",
                    "requirement_type": "practice",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Clinical laboratory values as specified in the study protocol",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinical laboratory values"
                    ],
                    "criterion": "clinical laboratory values",
                    "requirement_type": "specification",
                    "expected_value": "as specified in the study protocol"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "volunteer health status",
                    "requirement_type": "status",
                    "expected_value": "healthy"
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previous treatment with brentuximab vedotin.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previous treatment with brentuximab vedotin"
                    ],
                    "criterion": "brentuximab vedotin",
                    "requirement_type": "previous treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Previously received an allogeneic transplant.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Previously received an allogeneic transplant"
                    ],
                    "criterion": "allogeneic transplant",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL] (participants whose ALCL has transformed to sALCL are eligible).",
            "criterions": [
                {
                    "exact_snippets": [
                        "current diagnosis of primary cutaneous anaplastic large cell lymphoma [ALCL]"
                    ],
                    "criterion": "primary cutaneous anaplastic large cell lymphoma [ALCL]",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "participants whose ALCL has transformed to sALCL are eligible"
                    ],
                    "criterion": "transformation to sALCL",
                    "requirement_type": "eligibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known cerebral/meningeal disease"
                    ],
                    "criterion": "cerebral/meningeal disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "signs or symptoms of progressive multifocal leukoencephalopathy (PML)"
                    ],
                    "criterion": "progressive multifocal leukoencephalopathy (PML)",
                    "requirement_type": "signs or symptoms",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Female participants who are lactating and breastfeeding or pregnant",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female participants"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specificity",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known human immunodeficiency virus (HIV) positive",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known human immunodeficiency virus (HIV) positive"
                    ],
                    "criterion": "HIV status",
                    "requirement_type": "presence",
                    "expected_value": "positive"
                }
            ]
        },
        {
            "line": "* Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known hepatitis B surface antigen-positive"
                    ],
                    "criterion": "hepatitis B surface antigen",
                    "requirement_type": "status",
                    "expected_value": "positive"
                },
                {
                    "exact_snippets": [
                        "known or suspected active hepatitis C infection"
                    ],
                    "criterion": "hepatitis C infection",
                    "requirement_type": "activity",
                    "expected_value": "active"
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}