{
    "info": {
        "nct_id": "NCT04687982",
        "official_title": "Feasibility and Efficacy of Modified Donor Lymphocytes Infusion (CD45RA Negative Selected) After Haploidentical Transplantation With Post-transplantation Cyclophosphamide in Patients With Hematological Malignancies (ONC-2016-002).",
        "inclusion_criteria": "1. Written, signed informed consent;\n2. Adult patients aged ≥18 years;\n3. Patients who underwent haploidentical transplantation with PT-Cy for haematological diseases since no more than 56 days;\n4. Patient who received myeloablative conditioning regimen, reduced intensity conditioning regimens, or non-myeloablative conditioning regimens;\n5. Availability of haploidentical donor (defined as those with ≥ 2 differences within one HLA haplotype) who agree to donate peripheral blood cells by leukapheresis and able to donate the day before the day planned for infusion (or up to - 7 days);\n6. GVHD/HVG prophylaxis consists in Cyclophosphamide: 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5 to day +100, with tapering in 2 months Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Presence of grade 2-4 acute GVHD;\n2. Uncontrolled bacterial, viral or fungal infection;\n3. Aplasia defined as ANC less than 500/L;\n4. Evidence of disease progression after transplantation;\n5. Current participation in another clinical study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Written, signed informed consent;",
            "criterions": [
                {
                    "exact_snippets": "Written, signed informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "form",
                            "expected_value": "written"
                        },
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adult patients aged ≥18 years;",
            "criterions": [
                {
                    "exact_snippets": "Adult patients aged ≥18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who underwent haploidentical transplantation with PT-Cy for haematological diseases since no more than 56 days;",
            "criterions": [
                {
                    "exact_snippets": "Patients who underwent haploidentical transplantation",
                    "criterion": "haploidentical transplantation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "PT-Cy",
                    "criterion": "PT-Cy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "haematological diseases",
                    "criterion": "haematological diseases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "since no more than 56 days",
                    "criterion": "time since transplantation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 56,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient who received myeloablative conditioning regimen, reduced intensity conditioning regimens, or non-myeloablative conditioning regimens;",
            "criterions": [
                {
                    "exact_snippets": "Patient who received myeloablative conditioning regimen",
                    "criterion": "myeloablative conditioning regimen",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient who received ... reduced intensity conditioning regimens",
                    "criterion": "reduced intensity conditioning regimens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient who received ... non-myeloablative conditioning regimens",
                    "criterion": "non-myeloablative conditioning regimens",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Availability of haploidentical donor (defined as those with ≥ 2 differences within one HLA haplotype) who agree to donate peripheral blood cells by leukapheresis and able to donate the day before the day planned for infusion (or up to - 7 days);",
            "criterions": [
                {
                    "exact_snippets": "Availability of haploidentical donor",
                    "criterion": "haploidentical donor",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "haploidentical donor (defined as those with ≥ 2 differences within one HLA haplotype)",
                    "criterion": "HLA haplotype differences",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "differences"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "donor ... agree to donate peripheral blood cells by leukapheresis",
                    "criterion": "donor agreement to donate",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "donor ... able to donate the day before the day planned for infusion (or up to - 7 days)",
                    "criterion": "donation timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "day before infusion or up to -7 days"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. GVHD/HVG prophylaxis consists in Cyclophosphamide: 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5 to day +100, with tapering in 2 months Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35.",
            "criterions": [
                {
                    "exact_snippets": "Cyclophosphamide: 50 mg/kg/day, day +3 and +4",
                    "criterion": "Cyclophosphamide dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 50,
                                "unit": "mg/kg/day"
                            }
                        },
                        {
                            "requirement_type": "administration days",
                            "expected_value": [
                                "day +3",
                                "day +4"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Cyclosporine A: 3 mg/kg/day from day +5 to day +100, with tapering in 2 months",
                    "criterion": "Cyclosporine A dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "mg/kg/day"
                            }
                        },
                        {
                            "requirement_type": "administration period",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "day"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 100,
                                        "unit": "day"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "tapering period",
                            "expected_value": "2 months"
                        }
                    ]
                },
                {
                    "exact_snippets": "Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35",
                    "criterion": "Mycophenolate mofetil dosage",
                    "requirements": [
                        {
                            "requirement_type": "dosage",
                            "expected_value": {
                                "operator": "=",
                                "value": 45,
                                "unit": "mg/kg/day"
                            }
                        },
                        {
                            "requirement_type": "administration period",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "day"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 35,
                                        "unit": "day"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Presence of grade 2-4 acute GVHD;",
            "criterions": [
                {
                    "exact_snippets": "Presence of grade 2-4 acute GVHD",
                    "criterion": "acute GVHD",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "grade"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 4,
                                        "unit": "grade"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Uncontrolled bacterial, viral or fungal infection;",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled bacterial ... infection",
                    "criterion": "bacterial infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... viral ... infection",
                    "criterion": "viral infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled ... fungal infection",
                    "criterion": "fungal infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Aplasia defined as ANC less than 500/L;",
            "criterions": [
                {
                    "exact_snippets": "Aplasia defined as ANC less than 500/L",
                    "criterion": "ANC (Absolute Neutrophil Count)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 500,
                                "unit": "/L"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Evidence of disease progression after transplantation;",
            "criterions": [
                {
                    "exact_snippets": "Evidence of disease progression after transplantation",
                    "criterion": "disease progression after transplantation",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Current participation in another clinical study.",
            "criterions": [
                {
                    "exact_snippets": "Current participation in another clinical study",
                    "criterion": "participation in another clinical study",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}