{
    "info": {
        "nct_id": "NCT04943757",
        "official_title": "Graft-versus-host Disease Prophylaxis With Combination of Post-transplantation Benadamustine and Cyclophosphamide in Patients With Refractory Myeloid Malignancies (PTBCy)",
        "inclusion_criteria": "* Patients with indication for allogeneic hematopoietic stem cell transplantation\n* Patients with 5-10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.\n* Peripheral blood stem cells or bone marrow as a graft source\n* Diagnosis:\n\nAcute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms\n\n* Salvage hematopoietic stem cell transplantation defined as:\n* Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm\n* No severe concurrent illness\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 70 Years",
        "exclusion_criteria": "* Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%\n* Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted\n* Respiratory distress >grade I\n* Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits\n* Creatinine clearance < 60 mL/min\n* Uncontrolled bacterial or fungal infection at the time of enrollment\n* Requirement for vasopressor support at the time of enrollment\n* Karnofsky index <30%\n* Pregnancy\n* Somatic or psychiatric disorder making the patient unable to sign informed consent",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with indication for allogeneic hematopoietic stem cell transplantation",
            "criterions": [
                {
                    "exact_snippets": "indication for allogeneic hematopoietic stem cell transplantation",
                    "criterion": "indication for allogeneic hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with 5-10/10 HLA-matched related or unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1.",
            "criterions": [
                {
                    "exact_snippets": "5-10/10 HLA-matched related or unrelated donor available",
                    "criterion": "HLA-matched donor",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "matching",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "HLA-matched"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "HLA-matched"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1",
                    "criterion": "genetic loci matching",
                    "requirements": [
                        {
                            "requirement_type": "loci",
                            "expected_value": [
                                "HLA-A",
                                "HLA-B",
                                "HLA-Cw",
                                "HLA-DRB1",
                                "HLA-DQB1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral blood stem cells or bone marrow as a graft source",
            "criterions": [
                {
                    "exact_snippets": "Peripheral blood stem cells ... as a graft source",
                    "criterion": "peripheral blood stem cells",
                    "requirements": [
                        {
                            "requirement_type": "graft source",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "bone marrow as a graft source",
                    "criterion": "bone marrow",
                    "requirements": [
                        {
                            "requirement_type": "graft source",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Acute myeloid leukemia Chronic myeloid leukemia, Ph+ Myelodysplastic Syndromes Myeloprolipherative neoplasms",
            "criterions": [
                {
                    "exact_snippets": "Acute myeloid leukemia",
                    "criterion": "acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Chronic myeloid leukemia, Ph+",
                    "criterion": "chronic myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "Philadelphia chromosome",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Myelodysplastic Syndromes",
                    "criterion": "myelodysplastic syndromes",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Myeloprolipherative neoplasms",
                    "criterion": "myeloproliferative neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Salvage hematopoietic stem cell transplantation defined as:",
            "criterions": [
                {
                    "exact_snippets": "Salvage hematopoietic stem cell transplantation",
                    "criterion": "salvage hematopoietic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "defined as"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
            "criterions": [
                {
                    "exact_snippets": "Acute myeloid leukemia: >5% of clonal blasts despite adequate previous induction therapy or allogeneic stem cell transplantation",
                    "criterion": "acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "clonal blasts percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "previous therapy",
                            "expected_value": [
                                "adequate previous induction therapy",
                                "allogeneic stem cell transplantation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Myelodysplastic Syndrome: >10% of blasts despite previous therapy with -7 or complex karyotype, or p53 mutation",
                    "criterion": "myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "blasts percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "previous therapy",
                            "expected_value": [
                                "-7 karyotype",
                                "complex karyotype",
                                "p53 mutation"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Chronic myeloid leukemia: blast crisis or acceleration phase despite at least 3 previous lines of TKIs",
                    "criterion": "chronic myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "disease phase",
                            "expected_value": [
                                "blast crisis",
                                "acceleration phase"
                            ]
                        },
                        {
                            "requirement_type": "previous therapy",
                            "expected_value": "at least 3 previous lines of TKIs"
                        }
                    ]
                },
                {
                    "exact_snippets": "Myeloprolipherative neoplasms : high tumor burden despite previous therapy, including >20 000 WBC/ ul or splenomegaly >15 cm",
                    "criterion": "myeloproliferative neoplasms",
                    "requirements": [
                        {
                            "requirement_type": "tumor burden",
                            "expected_value": "high"
                        },
                        {
                            "requirement_type": "previous therapy",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "WBC count",
                            "expected_value": {
                                "operator": ">",
                                "value": 20000,
                                "unit": "WBC/ul"
                            }
                        },
                        {
                            "requirement_type": "splenomegaly size",
                            "expected_value": {
                                "operator": ">",
                                "value": 15,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No severe concurrent illness",
            "criterions": [
                {
                    "exact_snippets": "No severe concurrent illness",
                    "criterion": "concurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "not severe"
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 70 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Moderate or severe cardiac dysfunction, left ventricular ejection fraction <50%",
            "criterions": [
                {
                    "exact_snippets": "Moderate or severe cardiac dysfunction",
                    "criterion": "cardiac dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "left ventricular ejection fraction <50%",
                    "criterion": "left ventricular ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Moderate or severe decrease in pulmonary function, FEV1 <70% or DLCO<70% of predicted",
            "criterions": [
                {
                    "exact_snippets": "Moderate or severe decrease in pulmonary function",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "moderate",
                                "severe"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "FEV1 <70%",
                    "criterion": "FEV1",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "DLCO<70% of predicted",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Respiratory distress >grade I",
            "criterions": [
                {
                    "exact_snippets": "Respiratory distress >grade I",
                    "criterion": "respiratory distress",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Severe organ dysfunction: AST or ALT >5 upper normal limits, bilirubin >1.5 upper normal limits, creatinine >2 upper normal limits",
            "criterions": [
                {
                    "exact_snippets": "AST or ALT >5 upper normal limits",
                    "criterion": "AST or ALT levels",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "upper normal limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "bilirubin >1.5 upper normal limits",
                    "criterion": "bilirubin levels",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1.5,
                                "unit": "upper normal limits"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine >2 upper normal limits",
                    "criterion": "creatinine levels",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "upper normal limits"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Creatinine clearance < 60 mL/min",
            "criterions": [
                {
                    "exact_snippets": "Creatinine clearance < 60 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled bacterial or fungal infection at the time of enrollment",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled bacterial or fungal infection",
                    "criterion": "bacterial or fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Requirement for vasopressor support at the time of enrollment",
            "criterions": [
                {
                    "exact_snippets": "Requirement for vasopressor support",
                    "criterion": "vasopressor support",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky index <30%",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky index <30%",
                    "criterion": "Karnofsky index",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 30,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Somatic or psychiatric disorder making the patient unable to sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Somatic or psychiatric disorder",
                    "criterion": "somatic or psychiatric disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unable to sign informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}