{
    "info": {
        "nct_id": "NCT00460694",
        "official_title": "A Phase II Trial on Allogeneic Cytokine-induced Killer Cell Immunotherapy for Relapse After Allogeneic Marrow Transplant for Haematological Malignancies",
        "inclusion_criteria": "This trial includes only patients who have relapsed after an allogeneic transplant, who have either:\n\n1. No response to conventional DLI given for at least one dose, or\n2. No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant\n3. Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.\n\nIn view of the period taken to culture the cell to maturity, patient must have a life expectancy of more than one month. Interim measures eg chemotherapy or conventional DLI will be given during the interval so that ongoing treatment will not be compromised in any way.\nHealthy volunteers allowed\nMust have minimum age of 12 Years\nMust have maximum age of 60 Years",
        "exclusion_criteria": "1. Uncontrolled infection or significant bleeding\n2. Unstable vital signs\n3. Any degree of hypoxia requiring oxygen therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "This trial includes only patients who have relapsed after an allogeneic transplant, who have either:",
            "criterions": [
                {
                    "exact_snippets": "relapsed after an allogeneic transplant",
                    "criterion": "relapse after allogeneic transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. No response to conventional DLI given for at least one dose, or",
            "criterions": [
                {
                    "exact_snippets": "No response to conventional DLI given for at least one dose",
                    "criterion": "response to conventional DLI",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "dose"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. No possibility of access to large number of donor lymphocyte for repeated doses of DLI, This applies to cases of unrelated transplant or cord blood transplant",
            "criterions": [
                {
                    "exact_snippets": "No possibility of access to large number of donor lymphocyte for repeated doses of DLI",
                    "criterion": "access to donor lymphocyte",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unrelated transplant",
                    "criterion": "transplant type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "unrelated"
                        }
                    ]
                },
                {
                    "exact_snippets": "cord blood transplant",
                    "criterion": "transplant type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "cord blood"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patients who developed significant GVHD to conventional DLI, but had no other therapeutic option. In such cases the rationale is based on mice studies of mismatched CIK producing much less GVHD than mismatched unmanipulated splenocytes.",
            "criterions": [
                {
                    "exact_snippets": "Patients who developed significant GVHD to conventional DLI",
                    "criterion": "significant GVHD to conventional DLI",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had no other therapeutic option",
                    "criterion": "other therapeutic option",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "In view of the period taken to culture the cell to maturity, patient must have a life expectancy of more than one month. Interim measures eg chemotherapy or conventional DLI will be given during the interval so that ongoing treatment will not be compromised in any way.",
            "criterions": [
                {
                    "exact_snippets": "patient must have a life expectancy of more than one month",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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 12 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 12 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 60 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 60 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Uncontrolled infection or significant bleeding",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant bleeding",
                    "criterion": "bleeding",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Unstable vital signs",
            "criterions": [
                {
                    "exact_snippets": "Unstable vital signs",
                    "criterion": "vital signs",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Any degree of hypoxia requiring oxygen therapy.",
            "criterions": [
                {
                    "exact_snippets": "Any degree of hypoxia requiring oxygen therapy.",
                    "criterion": "hypoxia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "any degree"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "oxygen therapy"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}