{
    "info": {
        "nct_id": "NCT00027820",
        "official_title": "Low-Dose TBI and Fludarabine Followed by Nonmyeloablative Unrelated Donor Peripheral Blood Stem Cell Transplantation Using Enhanced Postgrafting Immunosuppression for Patients With Hematologic Malignancies and Renal Cell Carcinoma - A Multi-center Trial",
        "inclusion_criteria": "* Ages > 50 years with hematologic malignancies treatable by unrelated hematopoietic stem cell transplantation (HSCT)\n* Ages =< 50 years of age with hematologic diseases treatable by allogeneic HSCT who through pre-existing medical conditions or prior therapy are considered to be at high risk for regimen related toxicity associated with a conventional transplant (> 40% risk of transplant related mortality [TRM]) or those patients who refuse a conventional HSCT; transplants must be approved for these inclusion criteria by both the participating institution's patient review committee such as the Patient Care Conference (PCC at the Fred Hutchinson Cancer Research Center [FHCRC]) and by the principal investigator at the collaborating center; patients =< 50 years of age who have received previous autologous transplantation do not require patient review committee approval; all children < 12 years must be discussed with the FHCRC principal investigator (PI) prior to registration\n* Patients with metastatic renal cell carcinoma with the histologic subtypes of clear cell, papillary and medullary may be accepted regardless of age\n* The following diseases will be permitted although other diagnoses can be considered if approved by PCC or the participating institution's patient review committees and the principal investigator:\n\n  * Intermediate or high grade non-Hodgkin lymphoma (NHL) - not eligible for autologous HSCT or after failed autologous HSCT\n  * Low grade NHL - with < 6 month duration of complete remission (CR) between courses of conventional therapy\n  * Chronic lymphocytic leukemia (CLL) - must have failed two lines of conventional therapy and be refractory to fludarabine\n  * Hodgkin's disease (HD) - must have received and failed frontline therapy\n  * Multiple myeloma (MM) - must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HSCT is permitted\n  * Acute myeloid leukemia (AML) - must have < 5% marrow blasts at the time of transplant\n  * Acute lymphoblastic leukemia - must have < 5% blasts at the time of transplant\n  * Chronic myelogenous leukemia (CML) - patients will be accepted in chronic phase or accelerated phase; patients who have received prior autografts after high dose therapy or have undergone intensive chemotherapy with PBSC autologous or conventional HSCT for advanced CML may be enrolled provided they are in CR or chronic phase (CP) and have < 5% marrow blasts at time of transplant\n  * Myelodysplastic syndromes (MDS)/myeloproliferative disorder (MPD) - only patients with MDS/refractory anemia (RA) or MDS/refractory anemia with ringed sideroblasts (RARS) will be eligible for this protocol; additionally patients with myeloproliferative syndromes (MPS) will be eligible; those patients with MDS or MPS with > 5% marrow blasts (including those with transformation to AML) must receive cytotoxic chemotherapy and achieve < 5% marrow blasts at time of transplant\n  * Renal cell carcinoma - must have evidence of disease not amenable to surgical cure or history of or active metastatic disease by radiological and histologic criteria\n* DONOR: FHCRC matching allowed will be grade 1.0 to 2.1; unrelated donors who are prospectively:\n\n  * Matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing\n  * Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing\n* DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion\n* DONOR: Patient and donor pairs homozygous at a mismatched allele are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0201, and this type of mismatch is not allowed\n* DONOR: PBSC only will be permitted as a hematopoietic stem cell (HSC) source on this protocol\nHealthy volunteers allowed",
        "exclusion_criteria": "* Patients with rapidly progressive intermediate or high grade NHL\n* Renal cell carcinoma patients:\n\n  * With expected survival of less than 6 months\n  * Disease resulting in severely limited performance status (< 70%)\n  * Any vertebral instability\n  * History of brain metastases\n* Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy\n* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment\n* Females who are pregnant\n* Patients with non-hematological tumors except renal cell carcinoma\n* Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month\n* Cardiac ejection fraction < 35%; ejection fraction is required if there is a history of anthracycline exposure or history of cardiac disease\n* Diffusion capacity of the lung for carbon monoxide (DLCO) < 40% and/or receiving supplementary continuous oxygen\n* The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules\n* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease\n* Karnofsky scores < 60 (except renal cell carcinoma [RCC])\n* Patients with > grade II hypertension by common toxicity criteria (CTC)\n* Human immunodeficiency virus (HIV) positive patients\n* The addition of cytotoxic agents for \"cytoreduction\" with the exception of hydroxyurea and imatinib mesylate will not be allowed within two weeks of the initiation of conditioning\n* DONOR: Marrow donors\n* DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for filgrastim (G-CSF) mobilization and harvest of PBSC",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Ages > 50 years with hematologic malignancies treatable by unrelated hematopoietic stem cell transplantation (HSCT)",
            "criterions": [
                {
                    "exact_snippets": "Ages > 50 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hematologic malignancies",
                    "criterion": "hematologic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "treatable by unrelated hematopoietic stem cell transplantation (HSCT)",
                    "criterion": "treatability by unrelated hematopoietic stem cell transplantation (HSCT)",
                    "requirements": [
                        {
                            "requirement_type": "treatability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Ages =< 50 years of age with hematologic diseases treatable by allogeneic HSCT who through pre-existing medical conditions or prior therapy are considered to be at high risk for regimen related toxicity associated with a conventional transplant (> 40% risk of transplant related mortality [TRM]) or those patients who refuse a conventional HSCT; transplants must be approved for these inclusion criteria by both the participating institution's patient review committee such as the Patient Care Conference (PCC at the Fred Hutchinson Cancer Research Center [FHCRC]) and by the principal investigator at the collaborating center; patients =< 50 years of age who have received previous autologous transplantation do not require patient review committee approval; all children < 12 years must be discussed with the FHCRC principal investigator (PI) prior to registration",
            "criterions": [
                {
                    "exact_snippets": "Ages =< 50 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 50,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hematologic diseases treatable by allogeneic HSCT",
                    "criterion": "hematologic diseases treatable by allogeneic HSCT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pre-existing medical conditions or prior therapy ... high risk for regimen related toxicity",
                    "criterion": "high risk for regimen related toxicity",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": "high"
                        }
                    ]
                },
                {
                    "exact_snippets": "conventional transplant (> 40% risk of transplant related mortality [TRM])",
                    "criterion": "risk of transplant related mortality",
                    "requirements": [
                        {
                            "requirement_type": "risk",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who refuse a conventional HSCT",
                    "criterion": "refusal of conventional HSCT",
                    "requirements": [
                        {
                            "requirement_type": "refusal",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "transplants must be approved ... by both the participating institution's patient review committee ... and by the principal investigator",
                    "criterion": "transplant approval",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": [
                                "participating institution's patient review committee",
                                "principal investigator"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients =< 50 years of age who have received previous autologous transplantation do not require patient review committee approval",
                    "criterion": "previous autologous transplantation",
                    "requirements": [
                        {
                            "requirement_type": "approval exemption",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "all children < 12 years must be discussed with the FHCRC principal investigator (PI) prior to registration",
                    "criterion": "children < 12 years",
                    "requirements": [
                        {
                            "requirement_type": "discussion with PI",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with metastatic renal cell carcinoma with the histologic subtypes of clear cell, papillary and medullary may be accepted regardless of age",
            "criterions": [
                {
                    "exact_snippets": "metastatic renal cell carcinoma",
                    "criterion": "metastatic renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "histologic subtypes of clear cell, papillary and medullary",
                    "criterion": "histologic subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "clear cell",
                                "papillary",
                                "medullary"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "regardless of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "consideration",
                            "expected_value": "not applicable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The following diseases will be permitted although other diagnoses can be considered if approved by PCC or the participating institution's patient review committees and the principal investigator:",
            "criterions": [
                {
                    "exact_snippets": "The following diseases will be permitted",
                    "criterion": "disease diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": [
                                "PCC",
                                "participating institution's patient review committees",
                                "principal investigator"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intermediate or high grade non-Hodgkin lymphoma (NHL) - not eligible for autologous HSCT or after failed autologous HSCT",
            "criterions": [
                {
                    "exact_snippets": "Intermediate or high grade non-Hodgkin lymphoma (NHL)",
                    "criterion": "non-Hodgkin lymphoma (NHL)",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "Intermediate",
                                "high"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "not eligible for autologous HSCT",
                    "criterion": "eligibility for autologous HSCT",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "after failed autologous HSCT",
                    "criterion": "autologous HSCT",
                    "requirements": [
                        {
                            "requirement_type": "outcome",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Low grade NHL - with < 6 month duration of complete remission (CR) between courses of conventional therapy",
            "criterions": [
                {
                    "exact_snippets": "Low grade NHL",
                    "criterion": "NHL grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "low"
                        }
                    ]
                },
                {
                    "exact_snippets": "< 6 month duration of complete remission (CR) between courses of conventional therapy",
                    "criterion": "duration of complete remission",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic lymphocytic leukemia (CLL) - must have failed two lines of conventional therapy and be refractory to fludarabine",
            "criterions": [
                {
                    "exact_snippets": "Chronic lymphocytic leukemia (CLL)",
                    "criterion": "chronic lymphocytic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have failed two lines of conventional therapy",
                    "criterion": "lines of conventional therapy",
                    "requirements": [
                        {
                            "requirement_type": "failure",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to fludarabine",
                    "criterion": "fludarabine",
                    "requirements": [
                        {
                            "requirement_type": "refractory",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hodgkin's disease (HD) - must have received and failed frontline therapy",
            "criterions": [
                {
                    "exact_snippets": "Hodgkin's disease (HD)",
                    "criterion": "Hodgkin's disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have received and failed frontline therapy",
                    "criterion": "frontline therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "failed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Multiple myeloma (MM) - must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HSCT is permitted",
            "criterions": [
                {
                    "exact_snippets": "Multiple myeloma (MM)",
                    "criterion": "multiple myeloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have received prior chemotherapy",
                    "criterion": "prior chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "consolidation of chemotherapy by autografting prior to nonmyeloablative HSCT is permitted",
                    "criterion": "consolidation of chemotherapy by autografting",
                    "requirements": [
                        {
                            "requirement_type": "permission",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute myeloid leukemia (AML) - must have < 5% marrow blasts at the time of transplant",
            "criterions": [
                {
                    "exact_snippets": "Acute myeloid leukemia (AML)",
                    "criterion": "acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "< 5% marrow blasts at the time of transplant",
                    "criterion": "marrow blasts",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Acute lymphoblastic leukemia - must have < 5% blasts at the time of transplant",
            "criterions": [
                {
                    "exact_snippets": "Acute lymphoblastic leukemia - must have < 5% blasts",
                    "criterion": "blasts in acute lymphoblastic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Chronic myelogenous leukemia (CML) - patients will be accepted in chronic phase or accelerated phase; patients who have received prior autografts after high dose therapy or have undergone intensive chemotherapy with PBSC autologous or conventional HSCT for advanced CML may be enrolled provided they are in CR or chronic phase (CP) and have < 5% marrow blasts at time of transplant",
            "criterions": [
                {
                    "exact_snippets": "Chronic myelogenous leukemia (CML)",
                    "criterion": "chronic myelogenous leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic phase or accelerated phase",
                    "criterion": "CML phase",
                    "requirements": [
                        {
                            "requirement_type": "phase",
                            "expected_value": [
                                "chronic",
                                "accelerated"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "prior autografts after high dose therapy",
                    "criterion": "prior autografts after high dose therapy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intensive chemotherapy with PBSC autologous or conventional HSCT for advanced CML",
                    "criterion": "intensive chemotherapy with PBSC autologous or conventional HSCT",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "in CR or chronic phase (CP)",
                    "criterion": "remission or phase",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "CR",
                                "chronic phase"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "< 5% marrow blasts at time of transplant",
                    "criterion": "marrow blasts",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Myelodysplastic syndromes (MDS)/myeloproliferative disorder (MPD) - only patients with MDS/refractory anemia (RA) or MDS/refractory anemia with ringed sideroblasts (RARS) will be eligible for this protocol; additionally patients with myeloproliferative syndromes (MPS) will be eligible; those patients with MDS or MPS with > 5% marrow blasts (including those with transformation to AML) must receive cytotoxic chemotherapy and achieve < 5% marrow blasts at time of transplant",
            "criterions": [
                {
                    "exact_snippets": "Myelodysplastic syndromes (MDS)/myeloproliferative disorder (MPD) - only patients with MDS/refractory anemia (RA) or MDS/refractory anemia with ringed sideroblasts (RARS) will be eligible",
                    "criterion": "myelodysplastic syndromes (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "refractory anemia (RA)",
                                "refractory anemia with ringed sideroblasts (RARS)"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with myeloproliferative syndromes (MPS) will be eligible",
                    "criterion": "myeloproliferative syndromes (MPS)",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with MDS or MPS with > 5% marrow blasts (including those with transformation to AML) must receive cytotoxic chemotherapy and achieve < 5% marrow blasts at time of transplant",
                    "criterion": "marrow blasts",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "cytotoxic chemotherapy"
                        },
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "%"
                            }
                        },
                        {
                            "requirement_type": "time",
                            "expected_value": "at time of transplant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal cell carcinoma - must have evidence of disease not amenable to surgical cure or history of or active metastatic disease by radiological and histologic criteria",
            "criterions": [
                {
                    "exact_snippets": "Renal cell carcinoma",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of disease not amenable to surgical cure",
                    "criterion": "disease amenability to surgical cure",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of or active metastatic disease",
                    "criterion": "metastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "by radiological and histologic criteria",
                    "criterion": "diagnostic criteria",
                    "requirements": [
                        {
                            "requirement_type": "methods",
                            "expected_value": [
                                "radiological",
                                "histologic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: FHCRC matching allowed will be grade 1.0 to 2.1; unrelated donors who are prospectively:",
            "criterions": [
                {
                    "exact_snippets": "FHCRC matching allowed will be grade 1.0 to 2.1",
                    "criterion": "FHCRC matching grade",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1.0,
                                        "unit": ""
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2.1,
                                        "unit": ""
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1 by high resolution typing",
            "criterions": [
                {
                    "exact_snippets": "Matched for human leukocyte antigen (HLA)-A, B, C, DRB1 and DQB1",
                    "criterion": "HLA matching",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "HLA-A",
                                "HLA-B",
                                "HLA-C",
                                "HLA-DRB1",
                                "HLA-DQB1"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "high resolution typing",
                    "criterion": "HLA typing resolution",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing",
            "criterions": [
                {
                    "exact_snippets": "Only a single allele disparity will be allowed for HLA-A, B, or C",
                    "criterion": "HLA allele disparity",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "allele"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "as defined by high resolution typing",
                    "criterion": "HLA typing method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": "high resolution typing"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: A positive anti-donor cytotoxic crossmatch is an absolute donor exclusion",
            "criterions": [
                {
                    "exact_snippets": "A positive anti-donor cytotoxic crossmatch",
                    "criterion": "anti-donor cytotoxic crossmatch",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Patient and donor pairs homozygous at a mismatched allele are considered a two-allele mismatch, i.e., the patient is A*0101 and the donor is A*0201, and this type of mismatch is not allowed",
            "criterions": [
                {
                    "exact_snippets": "Patient and donor pairs homozygous at a mismatched allele ... this type of mismatch is not allowed",
                    "criterion": "allele mismatch",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: PBSC only will be permitted as a hematopoietic stem cell (HSC) source on this protocol",
            "criterions": [
                {
                    "exact_snippets": "PBSC only will be permitted as a hematopoietic stem cell (HSC) source",
                    "criterion": "hematopoietic stem cell source",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "PBSC"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patients with rapidly progressive intermediate or high grade NHL",
            "criterions": [
                {
                    "exact_snippets": "rapidly progressive",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "rate",
                            "expected_value": "rapid"
                        }
                    ]
                },
                {
                    "exact_snippets": "intermediate or high grade NHL",
                    "criterion": "NHL grade",
                    "requirements": [
                        {
                            "requirement_type": "grade",
                            "expected_value": [
                                "intermediate",
                                "high"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal cell carcinoma patients:",
            "criterions": [
                {
                    "exact_snippets": "Renal cell carcinoma patients",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With expected survival of less than 6 months",
            "criterions": [
                {
                    "exact_snippets": "expected survival of less than 6 months",
                    "criterion": "expected survival",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Disease resulting in severely limited performance status (< 70%)",
            "criterions": [
                {
                    "exact_snippets": "Disease resulting in severely limited performance status (< 70%)",
                    "criterion": "performance status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 70,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any vertebral instability",
            "criterions": [
                {
                    "exact_snippets": "Any vertebral instability",
                    "criterion": "vertebral instability",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of brain metastases",
            "criterions": [
                {
                    "exact_snippets": "History of brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Central nervous system (CNS) involvement with disease refractory to intrathecal chemotherapy",
            "criterions": [
                {
                    "exact_snippets": "Central nervous system (CNS) involvement",
                    "criterion": "CNS involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "disease refractory to intrathecal chemotherapy",
                    "criterion": "disease refractory to intrathecal chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "resistance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment",
            "criterions": [
                {
                    "exact_snippets": "Fertile men or women",
                    "criterion": "fertility",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unwilling to use contraceptive techniques",
                    "criterion": "contraceptive use willingness",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "during and for 12 months following treatment",
                    "criterion": "contraceptive use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during and for 12 months following treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Females who are pregnant",
            "criterions": [
                {
                    "exact_snippets": "Females who are pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with non-hematological tumors except renal cell carcinoma",
            "criterions": [
                {
                    "exact_snippets": "non-hematological tumors",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "non-hematological"
                        }
                    ]
                },
                {
                    "exact_snippets": "except renal cell carcinoma",
                    "criterion": "tumor type",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "renal cell carcinoma"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than 1 month",
            "criterions": [
                {
                    "exact_snippets": "Fungal infections",
                    "criterion": "fungal infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "radiological progression",
                    "criterion": "radiological progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receipt of amphotericin B or active triazole",
                    "criterion": "receipt of amphotericin B or active triazole",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cardiac ejection fraction < 35%; ejection fraction is required if there is a history of anthracycline exposure or history of cardiac disease",
            "criterions": [
                {
                    "exact_snippets": "Cardiac ejection fraction < 35%",
                    "criterion": "cardiac ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 35,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ejection fraction is required if there is a history of anthracycline exposure",
                    "criterion": "history of anthracycline exposure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ejection fraction is required if there is a ... history of cardiac disease",
                    "criterion": "history of cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diffusion capacity of the lung for carbon monoxide (DLCO) < 40% and/or receiving supplementary continuous oxygen",
            "criterions": [
                {
                    "exact_snippets": "Diffusion capacity of the lung for carbon monoxide (DLCO) < 40%",
                    "criterion": "DLCO",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving supplementary continuous oxygen",
                    "criterion": "supplementary continuous oxygen",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The FHCRC PI of the study must approve of enrollment of all patients with pulmonary nodules",
            "criterions": [
                {
                    "exact_snippets": "pulmonary nodules",
                    "criterion": "pulmonary nodules",
                    "requirements": [
                        {
                            "requirement_type": "approval",
                            "expected_value": "FHCRC PI of the study must approve of enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with clinical or laboratory evidence of liver disease would be evaluated for the cause of liver disease, its clinical severity in terms of liver function, and the degree of portal hypertension; patients will be excluded if they are found to have fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, a history of bleeding esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis with total serum bilirubin > 3 mg/dL, and symptomatic biliary disease",
            "criterions": [
                {
                    "exact_snippets": "clinical or laboratory evidence of liver disease",
                    "criterion": "liver disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "fulminant liver failure",
                    "criterion": "fulminant liver failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cirrhosis of the liver with evidence of portal hypertension",
                    "criterion": "cirrhosis of the liver",
                    "requirements": [
                        {
                            "requirement_type": "evidence of portal hypertension",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "alcoholic hepatitis",
                    "criterion": "alcoholic hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "esophageal varices",
                    "criterion": "esophageal varices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "history of bleeding esophageal varices",
                    "criterion": "history of bleeding esophageal varices",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic encephalopathy",
                    "criterion": "hepatic encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "uncorrectable hepatic synthetic dysfunction evinced by prolongation of the prothrombin time",
                    "criterion": "uncorrectable hepatic synthetic dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "prolongation of the prothrombin time",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ascites related to portal hypertension",
                    "criterion": "ascites related to portal hypertension",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bacterial or fungal liver abscess",
                    "criterion": "bacterial or fungal liver abscess",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "biliary obstruction",
                    "criterion": "biliary obstruction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic viral hepatitis with total serum bilirubin > 3 mg/dL",
                    "criterion": "chronic viral hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "total serum bilirubin",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic biliary disease",
                    "criterion": "symptomatic biliary disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky scores < 60 (except renal cell carcinoma [RCC])",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky scores < 60",
                    "criterion": "Karnofsky score",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "except renal cell carcinoma [RCC]",
                    "criterion": "renal cell carcinoma",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with > grade II hypertension by common toxicity criteria (CTC)",
            "criterions": [
                {
                    "exact_snippets": "Patients with > grade II hypertension by common toxicity criteria (CTC)",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV) positive patients",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The addition of cytotoxic agents for \"cytoreduction\" with the exception of hydroxyurea and imatinib mesylate will not be allowed within two weeks of the initiation of conditioning",
            "criterions": [
                {
                    "exact_snippets": "The addition of cytotoxic agents ... will not be allowed within two weeks of the initiation of conditioning",
                    "criterion": "cytotoxic agents",
                    "requirements": [
                        {
                            "requirement_type": "addition",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "with the exception of hydroxyurea and imatinib mesylate",
                    "criterion": "cytotoxic agents exception",
                    "requirements": [
                        {
                            "requirement_type": "allowed agents",
                            "expected_value": [
                                "hydroxyurea",
                                "imatinib mesylate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Marrow donors",
            "criterions": [
                {
                    "exact_snippets": "DONOR: Marrow donors",
                    "criterion": "donor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "marrow"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Donors who are HIV-positive and/or, medical conditions that would result in increased risk for filgrastim (G-CSF) mobilization and harvest of PBSC",
            "criterions": [
                {
                    "exact_snippets": "Donors who are HIV-positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "medical conditions that would result in increased risk for filgrastim (G-CSF) mobilization and harvest of PBSC",
                    "criterion": "medical conditions",
                    "requirements": [
                        {
                            "requirement_type": "risk for filgrastim (G-CSF) mobilization and harvest of PBSC",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}