{
    "info": {
        "nct_id": "NCT01982682",
        "official_title": "A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor",
        "inclusion_criteria": "1. This treatment is for patients with high risk hematologic malignancies. High risk is defined as:\n\n   * Any patient with a hematologic malignancy with residual disease after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely\n   * Patients without morphologic evidence of disease but with high risk features which would predict for relapse despite remission at HSCT such as adverse cytogenetics, 3rd or greater CR (complete response), or failure to recover peripheral blood counts to normal ranges. While these patients do not have detectable disease by current methods, like all patients they have non-detectable disease which in their case is highly aggressive.\n2. Patients must have one related donor who is HLA (human leukocyte antigen) mismatched in the GVHD direction at two or more HLA loci\n3. Patients must adequate organ function:\n\n   * LVEF (left ventricular ejection fraction) of >50 %\n   * Diffusing capacity of the lungs for carbon monoxide (DLCO) (adjusted for hemoglobin) >50 % of predicted and forced expiration to the full FEV-1 >50 %\n   * Adequate liver function as defined by a serum bilirubin <1.8, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) < 2.5X upper limit of normal\n   * Creatinine clearance of > 60 ml/min\n4. Karnofsky Performance Status (KPS) of > 80% on the modified (KPS) tool\n5. Patients must be willing to use contraception if they have childbearing potential\n6. Able to give informed consent\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Modified (KPS) Karnofsky Performance status of <80%\n2. > 5 Comorbidity Points on the Hematopoietic cell transplantation - specific comorbidity (HCT-CI) Index (See Appendix B)\n3. Class I or II antibodies against donor human leukocyte antigens (HLA)\n4. HIV positive\n5. Active involvement of the central nervous system with malignancy\n6. Psychiatric disorder that would preclude patients from signing an informed consent\n7. Pregnancy, or unwillingness to use contraception if they have child bearing potential\n8. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder\n9. Alemtuzumab treatment within 8 weeks of HSCT admission\n10. Anti-thymocyte globulin (ATG) level of > 2 ugm/ml\n11. Patients with active inflammatory processes including T max >101 or active tissue inflammation are excluded\n12. Inability to tolerate cyclophosphamide or undergo total body irradiation at the doses specified in the treatment plan",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. This treatment is for patients with high risk hematologic malignancies. High risk is defined as:",
            "criterions": [
                {
                    "exact_snippets": "high risk hematologic malignancies",
                    "criterion": "hematologic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any patient with a hematologic malignancy with residual disease after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely",
            "criterions": [
                {
                    "exact_snippets": "hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "residual disease after treatment",
                    "criterion": "residual disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with 1 or more chemotherapy regimens",
                    "criterion": "chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "achievement of remission with additional chemoradiotherapy is felt to be unlikely",
                    "criterion": "remission likelihood with additional chemoradiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "likelihood",
                            "expected_value": "unlikely"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients without morphologic evidence of disease but with high risk features which would predict for relapse despite remission at HSCT such as adverse cytogenetics, 3rd or greater CR (complete response), or failure to recover peripheral blood counts to normal ranges. While these patients do not have detectable disease by current methods, like all patients they have non-detectable disease which in their case is highly aggressive.",
            "criterions": [
                {
                    "exact_snippets": "morphologic evidence of disease",
                    "criterion": "morphologic evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk features",
                    "criterion": "high risk features",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adverse cytogenetics",
                    "criterion": "adverse cytogenetics",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "3rd or greater CR (complete response)",
                    "criterion": "complete response (CR)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "CR"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "failure to recover peripheral blood counts to normal ranges",
                    "criterion": "peripheral blood counts",
                    "requirements": [
                        {
                            "requirement_type": "recovery",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Patients must have one related donor who is HLA (human leukocyte antigen) mismatched in the GVHD direction at two or more HLA loci",
            "criterions": [
                {
                    "exact_snippets": "Patients must have one related donor",
                    "criterion": "related donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "HLA (human leukocyte antigen) mismatched",
                    "criterion": "HLA mismatched",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mismatched in the GVHD direction",
                    "criterion": "GVHD direction mismatch",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "mismatched ... at two or more HLA loci",
                    "criterion": "HLA loci mismatch",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "loci"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients must adequate organ function:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* LVEF (left ventricular ejection fraction) of >50 %",
            "criterions": [
                {
                    "exact_snippets": "LVEF (left ventricular ejection fraction) of >50 %",
                    "criterion": "LVEF (left ventricular ejection fraction)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diffusing capacity of the lungs for carbon monoxide (DLCO) (adjusted for hemoglobin) >50 % of predicted and forced expiration to the full FEV-1 >50 %",
            "criterions": [
                {
                    "exact_snippets": "Diffusing capacity of the lungs for carbon monoxide (DLCO) (adjusted for hemoglobin) >50 % of predicted",
                    "criterion": "DLCO (adjusted for hemoglobin)",
                    "requirements": [
                        {
                            "requirement_type": "percentage of predicted",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "forced expiration to the full FEV-1 >50 %",
                    "criterion": "FEV-1",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate liver function as defined by a serum bilirubin <1.8, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) < 2.5X upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "serum bilirubin <1.8",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.8,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST (aspartate aminotransferase) or ALT (alanine aminotransferase) < 2.5X upper limit of normal",
                    "criterion": "AST or ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "X upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance of > 60 ml/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance of > 60 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 60,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Karnofsky Performance Status (KPS) of > 80% on the modified (KPS) tool",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky Performance Status (KPS) of > 80%",
                    "criterion": "Karnofsky Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "score",
                            "expected_value": {
                                "operator": ">",
                                "value": 80,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Patients must be willing to use contraception if they have childbearing potential",
            "criterions": [
                {
                    "exact_snippets": "Patients must be willing to use contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if they have childbearing potential",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Able to give informed consent",
            "criterions": [
                {
                    "exact_snippets": "Able to give informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "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": "1. Modified (KPS) Karnofsky Performance status of <80%",
            "criterions": [
                {
                    "exact_snippets": "Modified (KPS) Karnofsky Performance status of <80%",
                    "criterion": "Karnofsky Performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 80,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. > 5 Comorbidity Points on the Hematopoietic cell transplantation - specific comorbidity (HCT-CI) Index (See Appendix B)",
            "criterions": [
                {
                    "exact_snippets": " > 5 Comorbidity Points on the Hematopoietic cell transplantation - specific comorbidity (HCT-CI) Index",
                    "criterion": "HCT-CI comorbidity points",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "points"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Class I or II antibodies against donor human leukocyte antigens (HLA)",
            "criterions": [
                {
                    "exact_snippets": "Class I or II antibodies against donor human leukocyte antigens (HLA)",
                    "criterion": "antibodies against donor HLA",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "I",
                                "II"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. HIV positive",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Active involvement of the central nervous system with malignancy",
            "criterions": [
                {
                    "exact_snippets": "Active involvement of the central nervous system with malignancy",
                    "criterion": "central nervous system involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Psychiatric disorder that would preclude patients from signing an informed consent",
            "criterions": [
                {
                    "exact_snippets": "Psychiatric disorder that would preclude patients from signing an informed consent",
                    "criterion": "psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "precludes signing informed consent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Pregnancy, or unwillingness to use contraception if they have child bearing potential",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unwillingness to use contraception if they have child bearing potential",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of < 6 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "reasons other than their underlying hematologic/oncologic disorder",
                    "criterion": "underlying disorder",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "hematologic disorder",
                                "oncologic disorder"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Alemtuzumab treatment within 8 weeks of HSCT admission",
            "criterions": [
                {
                    "exact_snippets": "Alemtuzumab treatment within 8 weeks of HSCT admission",
                    "criterion": "Alemtuzumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Anti-thymocyte globulin (ATG) level of > 2 ugm/ml",
            "criterions": [
                {
                    "exact_snippets": "Anti-thymocyte globulin (ATG) level of > 2 ugm/ml",
                    "criterion": "Anti-thymocyte globulin (ATG) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "ugm/ml"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Patients with active inflammatory processes including T max >101 or active tissue inflammation are excluded",
            "criterions": [
                {
                    "exact_snippets": "active inflammatory processes",
                    "criterion": "inflammatory processes",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "T max >101",
                    "criterion": "T max",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 101,
                                "unit": "F"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "active tissue inflammation",
                    "criterion": "tissue inflammation",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Inability to tolerate cyclophosphamide or undergo total body irradiation at the doses specified in the treatment plan",
            "criterions": [
                {
                    "exact_snippets": "Inability to tolerate cyclophosphamide",
                    "criterion": "tolerance to cyclophosphamide",
                    "requirements": [
                        {
                            "requirement_type": "tolerance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Inability to ... undergo total body irradiation at the doses specified in the treatment plan",
                    "criterion": "ability to undergo total body irradiation",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}