{
    "info": {
        "nct_id": "NCT00353860",
        "official_title": "Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed by T Cell Add-Back for Hematological Malignancies - Role of Preparative Regimen and T Cell Dose in Graft Rejection and GVHD",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 10 Years\nMust have maximum age of 80 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* INCLUSION CRITERIA - PATIENT:\n\nAges 10-55 years inclusive (but less than 56).\n\nChronic myelogenous leukemia in chronic phase\n\nA) Patients not treated with STI 571 under the age of 41 (subject to regular DSMB review);\n\nB) Age 10-55 in chronic phase who have failed treatment with STI-571;\n\nC) Age 10-55 in accelerated phase or blast transformation.\n\nAcute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in first remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second or subsequent remissions, primary induction failure, partially responding or untreated relapse.\n\nAcute myelogenous leukemia (AML): AML in first remission except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse.\n\nMyelodysplastic syndromes, any of these categories: refractory anemia with transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.\n\nMyeloproliferative disorders (myelofibrosis, polycythemia vera, essential thrombocythemia) in transformation to acute leukemia.\n\nChronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000/microliters) or anemia (less than or equal to 10 g/dl) not due to recent chemotherapy.\n\nNo major organ dysfunction precluding transplantation.\n\nDLCO greater than or equal to 60% predicted.\n\nLeft ventricular ejection fraction: greater than or equal to 40% predicted.\n\nECOG performance status of 0 or 1.\n\nFor adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian. Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.\n\nNegative pregnancy test for women of childbearing age.\n\nINCLUSION CRITERIA - DONORS:\n\nHLA 6/6 identical family donor.\n\nWeight greater than or equal to 18 kg.\n\nAge less than or equal to 80 years old.\n\nFit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).\n\nFor adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.\n\nEXCLUSION CRITERIA - RECIPIENT:\n\nPatient pregnant.\n\nAge less than 10 years and 56 years or more.\n\nPatients with CML in chronic phase who are 41 years or over in whom STI 571 is the treatment of choice.\n\nECOG performance status of 2 or more.\n\nSevere psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.\n\nMajor anticipated illness or organ failure incompatible with survival from BMT.\n\nDLCO less than 60% predicted.\n\nLeft ventricular ejection fraction: less than 40% predicted.\n\nSerum creatinine greater than 3 mg/dl.\n\nSerum bilirubin greater than 4 mg/dl.\n\nTransaminases greater than 3x upper limit of normal.\n\nHIV positive.\n\nHistory of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.\n\nIndividuals with diseases listed in the inclusion criteria but where debility or age makes the risk of intensive myeloablative therapy unacceptable. This includes patients who have received busulfan treatment for more than 6 months continuously. These patients will be considered for non-myeloablative allogeneic transplantation protocols.\n\nEXCLUSION CRITERIA - DONOR\n\nPregnant or lactating.\n\nDonor unfit to receive G-CSF and undergo apheresis. (uncontrolled hypertension, history of congestive heart failure, or unstable angina, thrombocytopenia).\n\nHIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the risk-benefit ratio is considered acceptable by the patient and investigator.\n\nWeight less than 18 kg.\n\nAge greater than 80 years.\n\nSevere psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible."
    },
    "inclusion_lines": [
        {
            "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 10 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 10 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 80 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 80 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "Ages 10-55 years inclusive (but less than 56).",
            "criterions": [
                {
                    "exact_snippets": "Ages 10-55 years inclusive (but less than 56)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 56,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chronic myelogenous leukemia in chronic phase",
            "criterions": [
                {
                    "exact_snippets": "Chronic myelogenous leukemia",
                    "criterion": "chronic myelogenous leukemia",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "chronic phase"
                        }
                    ]
                }
            ]
        },
        {
            "line": "A) Patients not treated with STI 571 under the age of 41 (subject to regular DSMB review);",
            "criterions": [
                {
                    "exact_snippets": "Patients not treated with STI 571",
                    "criterion": "STI 571 treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "under the age of 41",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<",
                                "value": 41,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "B) Age 10-55 in chronic phase who have failed treatment with STI-571;",
            "criterions": [
                {
                    "exact_snippets": "Age 10-55",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 55,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic phase",
                    "criterion": "disease phase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "failed treatment with STI-571",
                    "criterion": "treatment failure",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "STI-571"
                        }
                    ]
                }
            ]
        },
        {
            "line": "C) Age 10-55 in accelerated phase or blast transformation.",
            "criterions": [
                {
                    "exact_snippets": "Age 10-55",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 10,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 55,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "accelerated phase",
                    "criterion": "disease phase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "blast transformation",
                    "criterion": "disease phase",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in first remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second or subsequent remissions, primary induction failure, partially responding or untreated relapse.",
            "criterions": [
                {
                    "exact_snippets": "Acute lymphoblastic leukemia",
                    "criterion": "acute lymphoblastic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adults (greater than 18 years)",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "first remission",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "first remission"
                        }
                    ]
                },
                {
                    "exact_snippets": "high-risk features",
                    "criterion": "risk features",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "presenting leukocyte count greater than 100,000/cu mm",
                    "criterion": "leukocyte count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 100000,
                                "unit": "cu mm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "karyotypes t9; 22, t4, t19, t11",
                    "criterion": "karyotype",
                    "requirements": [
                        {
                            "requirement_type": "specific karyotypes",
                            "expected_value": [
                                "t9; 22",
                                "t4",
                                "t19",
                                "t11"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "biphenotypic leukemia",
                    "criterion": "biphenotypic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "All second or subsequent remissions",
                    "criterion": "remission status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "second or subsequent remissions"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary induction failure",
                    "criterion": "primary induction failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "partially responding",
                    "criterion": "response status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "partially responding"
                        }
                    ]
                },
                {
                    "exact_snippets": "untreated relapse",
                    "criterion": "relapse status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "untreated relapse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute myelogenous leukemia (AML): AML in first remission except AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21). All AML in second or subsequent remission, primary induction failure and resistant relapse.",
            "criterions": [
                {
                    "exact_snippets": "Acute myelogenous leukemia (AML)",
                    "criterion": "acute myelogenous leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "AML in first remission",
                    "criterion": "AML remission status",
                    "requirements": [
                        {
                            "requirement_type": "remission",
                            "expected_value": "first"
                        }
                    ]
                },
                {
                    "exact_snippets": "AML with good risk karyotypes: AML M3 (t15; 17), AML M4Eo (inv 16), AML t (8; 21)",
                    "criterion": "AML karyotype",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "good"
                        },
                        {
                            "requirement_type": "subtypes",
                            "expected_value": [
                                "AML M3 (t15; 17)",
                                "AML M4Eo (inv 16)",
                                "AML t (8; 21)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "All AML in second or subsequent remission",
                    "criterion": "AML remission status",
                    "requirements": [
                        {
                            "requirement_type": "remission",
                            "expected_value": "second or subsequent"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary induction failure",
                    "criterion": "AML treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "primary induction failure"
                        }
                    ]
                },
                {
                    "exact_snippets": "resistant relapse",
                    "criterion": "AML treatment response",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "resistant relapse"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Myelodysplastic syndromes, any of these categories: refractory anemia with transfusion dependence, refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.",
            "criterions": [
                {
                    "exact_snippets": "Myelodysplastic syndromes, any of these categories: refractory anemia with transfusion dependence",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "categories",
                            "expected_value": [
                                "refractory anemia with transfusion dependence",
                                "refractory anemia with excess of blasts",
                                "transformation to acute leukemia",
                                "chronic myelomonocytic leukemia"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Myeloproliferative disorders (myelofibrosis, polycythemia vera, essential thrombocythemia) in transformation to acute leukemia.",
            "criterions": [
                {
                    "exact_snippets": "Myeloproliferative disorders (myelofibrosis, polycythemia vera, essential thrombocythemia)",
                    "criterion": "myeloproliferative disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transformation to acute leukemia",
                    "criterion": "transformation to acute leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Chronic lymphocytic leukemia refractory to fludarabine treatment and with bulky progressive disease or with thrombocytopenia (less than or equal to 100,000/microliters) or anemia (less than or equal to 10 g/dl) not due to recent chemotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Chronic lymphocytic leukemia refractory to fludarabine treatment",
                    "criterion": "chronic lymphocytic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "refractory to fludarabine treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bulky progressive disease",
                    "criterion": "bulky progressive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombocytopenia (less than or equal to 100,000/microliters)",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "platelet count",
                            "expected_value": {
                                "operator": "<=",
                                "value": 100000,
                                "unit": "microliters"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "anemia (less than or equal to 10 g/dl)",
                    "criterion": "anemia",
                    "requirements": [
                        {
                            "requirement_type": "hemoglobin level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "g/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "not due to recent chemotherapy",
                    "criterion": "recent chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "cause of anemia or thrombocytopenia",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "No major organ dysfunction precluding transplantation.",
            "criterions": [
                {
                    "exact_snippets": "No major organ dysfunction",
                    "criterion": "major organ dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "precluding transplantation",
                    "criterion": "transplantation",
                    "requirements": [
                        {
                            "requirement_type": "preclusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "DLCO greater than or equal to 60% predicted.",
            "criterions": [
                {
                    "exact_snippets": "DLCO greater than or equal to 60% predicted.",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "% predicted"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Left ventricular ejection fraction: greater than or equal to 40% predicted.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction: greater than or equal to 40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0 or 1.",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian. Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.",
            "criterions": [
                {
                    "exact_snippets": "adults: Ability to comprehend the investigational nature of the study",
                    "criterion": "comprehension of study nature (adults)",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adults: ... provide informed consent",
                    "criterion": "informed consent (adults)",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "minors: Written informed consent from one parent or guardian",
                    "criterion": "written informed consent (minors)",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Informed oral consent from minors: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend",
                    "criterion": "oral consent (minors)",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Negative pregnancy test for women of childbearing age.",
            "criterions": [
                {
                    "exact_snippets": "Negative pregnancy test",
                    "criterion": "pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "women of childbearing age",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing age"
                        }
                    ]
                }
            ]
        },
        {
            "line": "HLA 6/6 identical family donor.",
            "criterions": [
                {
                    "exact_snippets": "HLA 6/6 identical family donor",
                    "criterion": "HLA identical family donor",
                    "requirements": [
                        {
                            "requirement_type": "match",
                            "expected_value": "6/6"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Weight greater than or equal to 18 kg.",
            "criterions": [
                {
                    "exact_snippets": "Weight greater than or equal to 18 kg.",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age less than or equal to 80 years old.",
            "criterions": [
                {
                    "exact_snippets": "Age less than or equal to 80 years old.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 80,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Fit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, no history of stroke).",
            "criterions": [
                {
                    "exact_snippets": "Fit to receive G-CSF",
                    "criterion": "G-CSF administration",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "give peripheral blood stem cells",
                    "criterion": "peripheral blood stem cell donation",
                    "requirements": [
                        {
                            "requirement_type": "fitness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "normal blood count",
                    "criterion": "blood count",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                },
                {
                    "exact_snippets": "normotensive",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normotensive"
                        }
                    ]
                },
                {
                    "exact_snippets": "no history of stroke",
                    "criterion": "history of stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "For adults: Ability to comprehend the investigational nature of the study and provide informed consent. For minors: Written informed consent from one parent or guardian and informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.",
            "criterions": [
                {
                    "exact_snippets": "For adults: Ability to comprehend the investigational nature of the study and provide informed consent.",
                    "criterion": "ability to comprehend and provide informed consent (adults)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "For minors: Written informed consent from one parent or guardian",
                    "criterion": "written informed consent from parent or guardian (minors)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "For minors: ... informed assent: The process will be explained to the minor on a level of complexity appropriate for their age and ability to comprehend.",
                    "criterion": "informed assent (minors)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patient pregnant.",
            "criterions": [
                {
                    "exact_snippets": "Patient pregnant.",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age less than 10 years and 56 years or more.",
            "criterions": [
                {
                    "exact_snippets": "Age less than 10 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 10,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Age ... 56 years or more",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 56,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients with CML in chronic phase who are 41 years or over in whom STI 571 is the treatment of choice.",
            "criterions": [
                {
                    "exact_snippets": "Patients with CML in chronic phase",
                    "criterion": "CML phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "chronic"
                        }
                    ]
                },
                {
                    "exact_snippets": "who are 41 years or over",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 41,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "STI 571 is the treatment of choice",
                    "criterion": "treatment choice",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "STI 571"
                        }
                    ]
                }
            ]
        },
        {
            "line": "ECOG performance status of 2 or more.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 2 or more",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.",
            "criterions": [
                {
                    "exact_snippets": "Severe psychiatric illness.",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.",
                    "criterion": "mental deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficiently severe"
                        },
                        {
                            "requirement_type": "impact on treatment compliance",
                            "expected_value": "unlikely"
                        },
                        {
                            "requirement_type": "impact on informed consent",
                            "expected_value": "impossible"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Major anticipated illness or organ failure incompatible with survival from BMT.",
            "criterions": [
                {
                    "exact_snippets": "Major anticipated illness",
                    "criterion": "anticipated illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "major"
                        }
                    ]
                },
                {
                    "exact_snippets": "organ failure incompatible with survival from BMT",
                    "criterion": "organ failure",
                    "requirements": [
                        {
                            "requirement_type": "compatibility with survival from BMT",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "DLCO less than 60% predicted.",
            "criterions": [
                {
                    "exact_snippets": "DLCO less than 60% predicted",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "predicted value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "predicted",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Left ventricular ejection fraction: less than 40% predicted.",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction: less than 40%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Serum creatinine greater than 3 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine greater than 3 mg/dl.",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Serum bilirubin greater than 4 mg/dl.",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin greater than 4 mg/dl.",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 4,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Transaminases greater than 3x upper limit of normal.",
            "criterions": [
                {
                    "exact_snippets": "Transaminases greater than 3x upper limit of normal.",
                    "criterion": "transaminases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "HIV positive.",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "History of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.",
            "criterions": [
                {
                    "exact_snippets": "History of other malignancies except basal cell or squamous carcinoma of the skin",
                    "criterion": "history of other malignancies",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "basal cell carcinoma of the skin",
                                "squamous carcinoma of the skin"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "positive PAP smear",
                    "criterion": "PAP smear",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "subsequent negative follow up",
                    "criterion": "follow up after positive PAP smear",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Individuals with diseases listed in the inclusion criteria but where debility or age makes the risk of intensive myeloablative therapy unacceptable. This includes patients who have received busulfan treatment for more than 6 months continuously. These patients will be considered for non-myeloablative allogeneic transplantation protocols.",
            "criterions": [
                {
                    "exact_snippets": "debility",
                    "criterion": "debility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "makes the risk of intensive myeloablative therapy unacceptable"
                        }
                    ]
                },
                {
                    "exact_snippets": "received busulfan treatment for more than 6 months continuously",
                    "criterion": "busulfan treatment duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "EXCLUSION CRITERIA - DONOR",
            "criterions": [
                {
                    "exact_snippets": "EXCLUSION CRITERIA - DONOR",
                    "criterion": "donor status",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Pregnant or lactating.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Donor unfit to receive G-CSF and undergo apheresis. (uncontrolled hypertension, history of congestive heart failure, or unstable angina, thrombocytopenia).",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "thrombocytopenia",
                    "criterion": "thrombocytopenia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "HIV positive. Donors who are positive for HBV, HCV or HTLV-1 may be used if the risk-benefit ratio is considered acceptable by the patient and investigator.",
            "criterions": [
                {
                    "exact_snippets": "HIV positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Donors who are positive for HBV",
                    "criterion": "HBV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Donors who are positive for ... HCV",
                    "criterion": "HCV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Donors who are positive for ... HTLV-1",
                    "criterion": "HTLV-1 status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Weight less than 18 kg.",
            "criterions": [
                {
                    "exact_snippets": "Weight less than 18 kg.",
                    "criterion": "weight",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 18,
                                "unit": "kg"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Age greater than 80 years.",
            "criterions": [
                {
                    "exact_snippets": "Age greater than 80 years.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 80,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.",
            "criterions": [
                {
                    "exact_snippets": "Severe psychiatric illness.",
                    "criterion": "psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely, and making informed consent impossible.",
                    "criterion": "mental deficiency",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "sufficiently severe"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* INCLUSION CRITERIA - PATIENT:",
            "criterions": []
        },
        {
            "line": "INCLUSION CRITERIA - DONORS:",
            "criterions": []
        },
        {
            "line": "EXCLUSION CRITERIA - RECIPIENT:",
            "criterions": []
        }
    ]
}