{
    "info": {
        "nct_id": "NCT00003960",
        "official_title": "Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 19 Years\nMust have maximum age of 55 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease\n\nPATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified"
    },
    "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 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 55 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 55 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 55,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "DISEASE CHARACTERISTICS: Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase Myelodysplastic syndrome Refractory anemia with excess blasts (RAEB) RAEB in transformation Secondary leukemias untreated or in complete remission 1 (CR1) Acute myeloid leukemia in complete remission 2 (CR2) Acute lymphocytic leukemia (ALL) in CR2 High-risk acute leukemia in CR1 Ph+ ALL in CR1 or consolidation after induction chemotherapy Must qualify for allogeneic bone marrow transplantation (BMT) No HLA-matched, sibling donor for BMT available No current CNS disease No history of more than 2 episodes of active CNS disease",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of any of the following: Chronic myelogenous leukemia (CML) in first chronic phase",
                    "criterion": "Chronic myelogenous leukemia (CML)",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": "first chronic phase"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Myelodysplastic syndrome",
                    "criterion": "Myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Refractory anemia with excess blasts (RAEB)",
                    "criterion": "Refractory anemia with excess blasts (RAEB)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... RAEB in transformation",
                    "criterion": "RAEB in transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Secondary leukemias untreated or in complete remission 1 (CR1)",
                    "criterion": "Secondary leukemias",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": [
                                "untreated",
                                "in complete remission 1 (CR1)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Acute myeloid leukemia in complete remission 2 (CR2)",
                    "criterion": "Acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission 2 (CR2)"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Acute lymphocytic leukemia (ALL) in CR2",
                    "criterion": "Acute lymphocytic leukemia (ALL)",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "CR2"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... High-risk acute leukemia in CR1",
                    "criterion": "High-risk acute leukemia",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "CR1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Diagnosis of any of the following: ... Ph+ ALL in CR1 or consolidation after induction chemotherapy",
                    "criterion": "Ph+ ALL",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "CR1"
                        },
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "consolidation after induction chemotherapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Must qualify for allogeneic bone marrow transplantation (BMT)",
                    "criterion": "qualification for allogeneic bone marrow transplantation (BMT)",
                    "requirements": [
                        {
                            "requirement_type": "qualification",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No HLA-matched, sibling donor for BMT available",
                    "criterion": "HLA-matched, sibling donor for BMT",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No current CNS disease",
                    "criterion": "current CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No history of more than 2 episodes of active CNS disease",
                    "criterion": "history of active CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "episode count",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "episodes"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PATIENT CHARACTERISTICS: Age: 19 to 55 Performance status: ECOG 0 or 1 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 2 mg/dL Renal: Creatinine no greater than 2 mg/dL Cardiovascular: LVEF at least 45% No active congestive heart failure, arrhythmia, or angina pectoris No myocardial infarction within the past 12 months Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy) Other: No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis) HIV negative Not pregnant Fertile patients must use effective contraception No concurrent debilitating medical or psychiatric illness that would preclude compliance No prior malignancy except curatively treated skin cancer or carcinoma of the cervix",
            "criterions": [
                {
                    "exact_snippets": "Age: 19 to 55",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 19,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 55,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Performance status: ECOG 0 or 1",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "ECOG",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Hepatic: Bilirubin no greater than 2 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Renal: Creatinine no greater than 2 mg/dL",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Cardiovascular: LVEF at least 45%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No active congestive heart failure, arrhythmia, or angina pectoris",
                    "criterion": "active cardiovascular conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No myocardial infarction within the past 12 months",
                    "criterion": "recent myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since last event",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Pulmonary: FEV1 and FVC at least 50% predicted (75% predicted if received prior thoracic or mantle radiotherapy)",
                    "criterion": "FEV1 and FVC",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50,
                                "unit": "% predicted"
                            }
                        },
                        {
                            "requirement_type": "minimum with prior radiotherapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75,
                                "unit": "% predicted"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "No active serious infection (e.g., mucormycosis, uncontrolled aspergillosis, or tuberculosis)",
                    "criterion": "active serious infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Not pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Fertile patients must use effective contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "requirement for fertile patients",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "No concurrent debilitating medical or psychiatric illness that would preclude compliance",
                    "criterion": "debilitating medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior malignancy except curatively treated skin cancer or carcinoma of the cervix",
                    "criterion": "prior malignancy",
                    "requirements": [
                        {
                            "requirement_type": "exceptions",
                            "expected_value": [
                                "curatively treated skin cancer",
                                "carcinoma of the cervix"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics No prior autologous or allogeneic bone marrow transplantation No prior transfusions from donor Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified",
            "criterions": [
                {
                    "exact_snippets": "No prior autologous or allogeneic bone marrow transplantation",
                    "criterion": "prior bone marrow transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No prior transfusions from donor",
                    "criterion": "prior donor transfusions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}