{
    "info": {
        "nct_id": "NCT00846703",
        "official_title": "Clinical Study of GD-2008 ALL Protocol for Childhood Acute Lymphoblastic Leukemia in Guangdong Province",
        "inclusion_criteria": "* Cytologically proven acute lymphoblastic leukemia (ALL)\n* No relapse of a previously unrecognized ALL\n* Patients must meet one of the following risk criteria:\n* Standard-risk (SR) group meeting all of the following criteria:\n* Blasts < 1,000/μL in peripheral blood (PB) on day 8\n* Aged 1 to < 6 years\n* Initial WBC < 20,000/μL\n* M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow on day 15;\n* M1 marrow on day 33.\n* Intermediate-risk (IR) group meeting all of the following criteria:\n\n  * Aged < 1 or ≥ 6 years and/or WBC ≥ 20,000/μL\n  * Blasts < 1,000/μL in PB on day 8\n  * M1 or M2 marrow on day 15\n  * M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and *M1 marrow on day 33.\n* High-risk (HR) group meeting ≥ 1 of the following criteria:\n\n  * Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)\n  * Blasts ≥ 1,000/μL in PB on day 8\n  * M2 or M3 marrow on day 33\n  * Translocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+].\nHealthy volunteers allowed\nMust have maximum age of 16 Years",
        "exclusion_criteria": "* No Down syndrome\n* No other major disease that prohibits study treatment (e.g., severe congenital heart disease)\n* Not requiring significant therapy modification owing to study therapy associated complications\n* No complications due to other interventions\n* No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Cytologically proven acute lymphoblastic leukemia (ALL)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Cytologically proven",
                        "acute lymphoblastic leukemia (ALL)"
                    ],
                    "criterion": "acute lymphoblastic leukemia (ALL)",
                    "requirement_type": "diagnosis confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* No relapse of a previously unrecognized ALL",
            "criterions": [
                {
                    "exact_snippets": [
                        "No relapse",
                        "ALL"
                    ],
                    "criterion": "acute lymphoblastic leukemia (ALL)",
                    "requirement_type": "relapse",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "previously unrecognized"
                    ],
                    "criterion": "acute lymphoblastic leukemia (ALL)",
                    "requirement_type": "recognition",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Patients must meet one of the following risk criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients must meet one of the following risk criteria"
                    ],
                    "criterion": "risk criteria",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Standard-risk (SR) group meeting all of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Standard-risk (SR) group"
                    ],
                    "criterion": "risk group",
                    "requirement_type": "classification",
                    "expected_value": "standard-risk"
                }
            ]
        },
        {
            "line": "* Blasts < 1,000/μL in peripheral blood (PB) on day 8",
            "criterions": [
                {
                    "exact_snippets": [
                        "Blasts < 1,000/μL in peripheral blood (PB)"
                    ],
                    "criterion": "blasts in peripheral blood",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Aged 1 to < 6 years",
            "criterions": [
                {
                    "exact_snippets": [
                        "Aged 1 to < 6 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            },
                            {
                                "operator": "<",
                                "value": 6
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Initial WBC < 20,000/μL",
            "criterions": [
                {
                    "exact_snippets": [
                        "Initial WBC < 20,000/μL"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 20000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow on day 15;",
            "criterions": [
                {
                    "exact_snippets": [
                        "M1 (5%) or M2 (≥ 5% to < 25%) blasts in bone marrow"
                    ],
                    "criterion": "blasts in bone marrow",
                    "requirement_type": "percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "=",
                                "value": 5
                            },
                            {
                                "operator": ">=",
                                "value": 5
                            },
                            {
                                "operator": "<",
                                "value": 25
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* M1 marrow on day 33.",
            "criterions": [
                {
                    "exact_snippets": [
                        "M1 marrow"
                    ],
                    "criterion": "marrow",
                    "requirement_type": "status",
                    "expected_value": "M1"
                },
                {
                    "exact_snippets": [
                        "day 33"
                    ],
                    "criterion": "day",
                    "requirement_type": "specific day",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Intermediate-risk (IR) group meeting all of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Intermediate-risk (IR) group"
                    ],
                    "criterion": "risk group",
                    "requirement_type": "classification",
                    "expected_value": "Intermediate-risk (IR)"
                }
            ]
        },
        {
            "line": "* Aged < 1 or ≥ 6 years and/or WBC ≥ 20,000/μL",
            "criterions": [
                {
                    "exact_snippets": [
                        "Aged < 1"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Aged",
                        "≥ 6 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 6
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "WBC ≥ 20,000/μL"
                    ],
                    "criterion": "white blood cell",
                    "requirement_type": "count",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 20000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Blasts < 1,000/μL in PB on day 8",
            "criterions": [
                {
                    "exact_snippets": [
                        "Blasts < 1,000/μL in PB"
                    ],
                    "criterion": "blasts in peripheral blood",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 1000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* M1 or M2 marrow on day 15",
            "criterions": [
                {
                    "exact_snippets": [
                        "M1 or M2 marrow on day 15"
                    ],
                    "criterion": "marrow",
                    "requirement_type": "classification",
                    "expected_value": [
                        "M1",
                        "M2"
                    ]
                },
                {
                    "exact_snippets": [
                        "on day 15"
                    ],
                    "criterion": "day",
                    "requirement_type": "specific day",
                    "expected_value": "15"
                }
            ]
        },
        {
            "line": "* M3 (≥ 25%) marrow on day 15 OR meets SR criteria but M3 marrow on day 15 and *M1 marrow on day 33.",
            "criterions": [
                {
                    "exact_snippets": [
                        "M3 (≥ 25%) marrow on day 15"
                    ],
                    "criterion": "M3 marrow",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 25
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "meets SR criteria"
                    ],
                    "criterion": "SR criteria",
                    "requirement_type": "compliance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "M3 marrow on day 15"
                    ],
                    "criterion": "M3 marrow",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "M1 marrow on day 33"
                    ],
                    "criterion": "M1 marrow",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* High-risk (HR) group meeting ≥ 1 of the following criteria:",
            "criterions": [
                {
                    "exact_snippets": [
                        "High-risk (HR) group meeting ≥ 1 of the following criteria"
                    ],
                    "criterion": "high-risk group",
                    "requirement_type": "membership",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Meets IR criteria and M3 marrow on day 15 (not SR and M3 on day 15)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Meets IR criteria"
                    ],
                    "criterion": "IR criteria",
                    "requirement_type": "compliance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "M3 marrow on day 15"
                    ],
                    "criterion": "marrow status",
                    "requirement_type": "status",
                    "expected_value": "M3"
                }
            ]
        },
        {
            "line": "* Blasts ≥ 1,000/μL in PB on day 8",
            "criterions": [
                {
                    "exact_snippets": [
                        "Blasts ≥ 1,000/μL in PB on day 8"
                    ],
                    "criterion": "blasts in peripheral blood",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1000
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* M2 or M3 marrow on day 33",
            "criterions": [
                {
                    "exact_snippets": [
                        "M2 or M3 marrow"
                    ],
                    "criterion": "marrow",
                    "requirement_type": "classification",
                    "expected_value": [
                        "M2",
                        "M3"
                    ]
                },
                {
                    "exact_snippets": [
                        "day 33"
                    ],
                    "criterion": "day",
                    "requirement_type": "specific day",
                    "expected_value": "33"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have maximum age of 16 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 16 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 16
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* No Down syndrome",
            "criterions": [
                {
                    "exact_snippets": [
                        "No Down syndrome"
                    ],
                    "criterion": "Down syndrome",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* No other major disease that prohibits study treatment (e.g., severe congenital heart disease)",
            "criterions": [
                {
                    "exact_snippets": [
                        "No other major disease"
                    ],
                    "criterion": "major disease",
                    "requirement_type": "presence",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "severe congenital heart disease"
                    ],
                    "criterion": "congenital heart disease",
                    "requirement_type": "severity",
                    "expected_value": "severe"
                }
            ]
        },
        {
            "line": "* Not requiring significant therapy modification owing to study therapy associated complications",
            "criterions": [
                {
                    "exact_snippets": [
                        "Not requiring significant therapy modification"
                    ],
                    "criterion": "therapy modification",
                    "requirement_type": "necessity",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "owing to study therapy associated complications"
                    ],
                    "criterion": "study therapy associated complications",
                    "requirement_type": "necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* No complications due to other interventions",
            "criterions": [
                {
                    "exact_snippets": [
                        "No complications due to other interventions"
                    ],
                    "criterion": "complications due to other interventions",
                    "requirement_type": "presence",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* No one with missing data that are needed for the differential diagnosis, or for selection of the proper therapy arm",
            "criterions": [
                {
                    "exact_snippets": [
                        "missing data that are needed for the differential diagnosis"
                    ],
                    "criterion": "data for differential diagnosis",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "missing data that are needed",
                        "for selection of the proper therapy arm"
                    ],
                    "criterion": "data for therapy arm selection",
                    "requirement_type": "availability",
                    "expected_value": true
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Translocation t(9;22) [BCR/ABL+] (Philadelphia chromosome-positive) or t(4;11) [MLL/AF4+].",
            "criterions": [
                {
                    "exact_snippets": [
                        "Translocation t(9;22) [BCR/ABL+]",
                        "Philadelphia chromosome-positive"
                    ],
                    "criterion": "Philadelphia chromosome",
                    "requirement_type": "translocation",
                    "expected_value": "t(9;22) [BCR/ABL+]"
                },
                {
                    "exact_snippets": [
                        "Translocation t(4;11) [MLL/AF4+]"
                    ],
                    "criterion": "MLL/AF4",
                    "requirement_type": "translocation",
                    "expected_value": "t(4;11)"
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}