{
    "info": {
        "nct_id": "NCT03599960",
        "official_title": "Combination Chemotherapy (Methotrexate, L-asparaginase, Idarubicin and Dexamethasone) in Patients With Newly Diagnosed Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)",
        "inclusion_criteria": "* Newly diagnosed BPDCN established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric and/or by the anatomic pathology study of a skin biopsy using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014) or patients with confirmed isolated skin lesion.\n* 18 years of age or older\n* No prior cytotoxic therapy except <2 week of corticosteroids or hydroxyurea\n* ECOG ≤2\n* Written informed consent\n* Affiliation to the French social security scheme\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Cardiac contra-indication to anthracyclines: cardiac dysfunction events (NYHA grade 3 or 4 and/or LVEF<50%)\n* Hepatocellular abnormalities except if considered related to the BPDCN:\n\n  1. ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN\n  2. Total bilirubin ≥ 2.5 x ULN\n* Creatinine level >1.5x ULN or creatinine clearance (MDRD)<50 mL/mn\n* Prior thrombotic event\n* Active hepatitis B or C virus infection\n* HIV positive\n* Serious medical or psychiatric illness that could interfere with the completion of treatment\n* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.\n* Pregnant and lactating female patients\n* Patients diagnosed with or treated for another malignancy within 2 years before study enrollment or with residual disease (basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection)",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Newly diagnosed BPDCN established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric and/or by the anatomic pathology study of a skin biopsy using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014) or patients with confirmed isolated skin lesion.",
            "criterions": [
                {
                    "exact_snippets": "Newly diagnosed BPDCN",
                    "criterion": "BPDCN diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "newly diagnosed"
                        }
                    ]
                },
                {
                    "exact_snippets": "established by a blood or bone marrow immunophenotypic diagnosis by flow cytometric",
                    "criterion": "blood or bone marrow immunophenotypic diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "flow cytometric"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "established by ... anatomic pathology study of a skin biopsy",
                    "criterion": "anatomic pathology study of a skin biopsy",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "anatomic pathology"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "using validated diagnostic criteria (Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008; Garnache-Ottou et al., 2009; Angelot et al., 2012; Julia et al., 2014)",
                    "criterion": "validated diagnostic criteria",
                    "requirements": [
                        {
                            "requirement_type": "source",
                            "expected_value": [
                                "Swerdlow SH CE et al., World Health Organisation Classification of Tumors, 2008",
                                "Garnache-Ottou et al., 2009",
                                "Angelot et al., 2012",
                                "Julia et al., 2014"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with confirmed isolated skin lesion",
                    "criterion": "isolated skin lesion",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No prior cytotoxic therapy except <2 week of corticosteroids or hydroxyurea",
            "criterions": [
                {
                    "exact_snippets": "No prior cytotoxic therapy",
                    "criterion": "prior cytotoxic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "<2 week of corticosteroids",
                    "criterion": "corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "week"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "<2 week of ... hydroxyurea",
                    "criterion": "hydroxyurea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "week"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG ≤2",
            "criterions": [
                {
                    "exact_snippets": "ECOG ≤2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Written informed consent",
            "criterions": [
                {
                    "exact_snippets": "Written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Affiliation to the French social security scheme",
            "criterions": [
                {
                    "exact_snippets": "Affiliation to the French social security scheme",
                    "criterion": "affiliation to the French social security scheme",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Cardiac contra-indication to anthracyclines: cardiac dysfunction events (NYHA grade 3 or 4 and/or LVEF<50%)",
            "criterions": [
                {
                    "exact_snippets": "Cardiac contra-indication to anthracyclines",
                    "criterion": "cardiac contra-indication to anthracyclines",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac dysfunction events (NYHA grade 3 or 4",
                    "criterion": "NYHA grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF<50%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatocellular abnormalities except if considered related to the BPDCN:",
            "criterions": [
                {
                    "exact_snippets": "Hepatocellular abnormalities",
                    "criterion": "hepatocellular abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ASAT (SGOT) and/or ALAT (SGPT) > 5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "ASAT (SGOT) ... > 5 x ULN",
                    "criterion": "ASAT (SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALAT (SGPT) > 5 x ULN",
                    "criterion": "ALAT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Total bilirubin ≥ 2.5 x ULN",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin ≥ 2.5 x ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine level >1.5x ULN or creatinine clearance (MDRD)<50 mL/mn",
            "criterions": [
                {
                    "exact_snippets": "Creatinine level >1.5x ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (MDRD)<50 mL/mn",
                    "criterion": "creatinine clearance (MDRD)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "mL/mn"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior thrombotic event",
            "criterions": [
                {
                    "exact_snippets": "Prior thrombotic event",
                    "criterion": "thrombotic event",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active hepatitis B or C virus infection",
            "criterions": [
                {
                    "exact_snippets": "Active hepatitis B",
                    "criterion": "hepatitis B virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Active ... C virus infection",
                    "criterion": "hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV positive",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serious medical or psychiatric illness that could interfere with the completion of treatment",
            "criterions": [
                {
                    "exact_snippets": "Serious medical ... illness that could interfere with the completion of treatment",
                    "criterion": "serious medical illness",
                    "requirements": [
                        {
                            "requirement_type": "potential interference with treatment completion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Serious ... psychiatric illness that could interfere with the completion of treatment",
                    "criterion": "serious psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "potential interference with treatment completion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.",
            "criterions": [
                {
                    "exact_snippets": "Known allergy to any of the study medications",
                    "criterion": "allergy to study medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known allergy to ... their analogues",
                    "criterion": "allergy to analogues of study medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Known allergy to ... excipients in the various formulations of any agent",
                    "criterion": "allergy to excipients in formulations",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and lactating female patients",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating female patients",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients diagnosed with or treated for another malignancy within 2 years before study enrollment or with residual disease (basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection)",
            "criterions": [
                {
                    "exact_snippets": "Patients diagnosed with or treated for another malignancy within 2 years before study enrollment",
                    "criterion": "another malignancy",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis or treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "residual disease",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "basal cell carcinoma or cervical carcinoma in situ patients may be enrolled if they have undergone complete resection",
                    "criterion": "basal cell carcinoma or cervical carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "resection",
                            "expected_value": "complete"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}