{
    "info": {
        "nct_id": "NCT02556931",
        "official_title": "Phase II Study of Shortened-duration Tacrolimus Following Nonmyeloablative Peripheral Blood Stem Cell Transplant With High-dose Posttransplantation Cyclophosphamide in Malignancies That Are Challenging to Engraft",
        "inclusion_criteria": "* Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor\n* Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing\n* Any previous autologous transplant must have occurred > 3 months ago\n* Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%\n* Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)\n* AST and ALT <= 5 x institutional upper limit of normal\n* FEV1 and FVC >= 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air\n* ECOG performance status <= 2, or Karnofsky/Lansky status >= 60\nHealthy volunteers allowed",
        "exclusion_criteria": "* Pregnancy or active breastfeeding\n* Uncontrolled active infection\n* Previous allogeneic transplant\n* Active extramedullary leukemia or active central nervous system (CNS) malignant disease",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Presence of a suitable related HLA-haploidentical or -matched stem cell donor, or a 10/10 matched unrelated donor",
            "criterions": [
                {
                    "exact_snippets": "Presence of a suitable related HLA-haploidentical or -matched stem cell donor",
                    "criterion": "related HLA-haploidentical or -matched stem cell donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Presence of a ... 10/10 matched unrelated donor",
                    "criterion": "10/10 matched unrelated donor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligible diagnoses: myelodysplastic syndrome (MDS) with at least 1 poor-risk feature; small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion or with progression < 6 months after a second or greater treatment regimen; T-cell prolymphocytic leukemia (PLL) in partial response or better; interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML), or CML in second or subsequent chronic phase; Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis; Multiple myeloma or plasma cell leukemia in partial response or better; Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing",
            "criterions": [
                {
                    "exact_snippets": "myelodysplastic syndrome (MDS) with at least 1 poor-risk feature",
                    "criterion": "myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "poor-risk feature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion",
                    "criterion": "small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL)",
                    "requirements": [
                        {
                            "requirement_type": "17p deletion",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) ... progression < 6 months after a second or greater treatment regimen",
                    "criterion": "small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL)",
                    "requirements": [
                        {
                            "requirement_type": "progression after treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T-cell prolymphocytic leukemia (PLL) in partial response or better",
                    "criterion": "T-cell prolymphocytic leukemia (PLL)",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "partial response or better"
                        }
                    ]
                },
                {
                    "exact_snippets": "interferon- or tyrosine-kinase-refractory chronic myeloid leukemia (CML)",
                    "criterion": "chronic myeloid leukemia (CML)",
                    "requirements": [
                        {
                            "requirement_type": "refractory to interferon or tyrosine-kinase",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "CML in second or subsequent chronic phase",
                    "criterion": "chronic myeloid leukemia (CML)",
                    "requirements": [
                        {
                            "requirement_type": "chronic phase",
                            "expected_value": "second or subsequent"
                        }
                    ]
                },
                {
                    "exact_snippets": "Philadelphia chromosome negative (Ph-) myeloproliferative disease, including myelofibrosis",
                    "criterion": "myeloproliferative disease",
                    "requirements": [
                        {
                            "requirement_type": "Philadelphia chromosome",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "Multiple myeloma or plasma cell leukemia in partial response or better",
                    "criterion": "Multiple myeloma or plasma cell leukemia",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "partial response or better"
                        }
                    ]
                },
                {
                    "exact_snippets": "Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, FISH, flow cytometry, or molecular testing",
                    "criterion": "Hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "remission status",
                            "expected_value": "complete remission with minimal residual disease (MRD) detectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any previous autologous transplant must have occurred > 3 months ago",
            "criterions": [
                {
                    "exact_snippets": "Any previous autologous transplant must have occurred > 3 months ago",
                    "criterion": "autologous transplant",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Left ventricular ejection fraction (LVEF) >= 35%, or shortening fraction > 25%",
            "criterions": [
                {
                    "exact_snippets": "Left ventricular ejection fraction (LVEF) >= 35%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 35,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "shortening fraction > 25%",
                    "criterion": "shortening fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 25,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Bilirubin <= 3.0 mg/dL (unless due to Gilbert's syndrome or hemolysis)",
            "criterions": [
                {
                    "exact_snippets": "Bilirubin <= 3.0 mg/dL",
                    "criterion": "bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT <= 5 x institutional upper limit of normal",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT <= 5 x institutional upper limit of normal",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT <= 5 x institutional upper limit of normal",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "x institutional upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* FEV1 and FVC >= 40% of predicted; if unable to perform pulmonary function testing, oxygen saturation > 92% on room air",
            "criterions": [
                {
                    "exact_snippets": "FEV1 and FVC >= 40% of predicted",
                    "criterion": "FEV1 and FVC",
                    "requirements": [
                        {
                            "requirement_type": "percentage of predicted",
                            "expected_value": {
                                "operator": ">=",
                                "value": 40,
                                "unit": "% of predicted"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "oxygen saturation > 92% on room air",
                    "criterion": "oxygen saturation",
                    "requirements": [
                        {
                            "requirement_type": "percentage",
                            "expected_value": {
                                "operator": ">",
                                "value": 92,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status <= 2, or Karnofsky/Lansky status >= 60",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status <= 2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky/Lansky status >= 60",
                    "criterion": "Karnofsky/Lansky status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Pregnancy or active breastfeeding",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "active breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled active infection",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "activity status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Previous allogeneic transplant",
            "criterions": [
                {
                    "exact_snippets": "Previous allogeneic transplant",
                    "criterion": "allogeneic transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active extramedullary leukemia or active central nervous system (CNS) malignant disease",
            "criterions": [
                {
                    "exact_snippets": "Active extramedullary leukemia",
                    "criterion": "extramedullary leukemia",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active central nervous system (CNS) malignant disease",
                    "criterion": "central nervous system (CNS) malignant disease",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}