{
    "info": {
        "nct_id": "NCT02333162",
        "official_title": "A Phase I Study of Intensity Modulated Total Marrow Irradiation (IMTMI) in Addition to Fludarabine/Melphalan Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies",
        "inclusion_criteria": "* Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators\n* Karnofsky performance status of 70 or above\n* Life expectancy is not severely limited by concomitant illness\n* Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =< 40% or diffusion capacity of carbon monoxide (DLCO) =< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol\n* Serum creatinine =<1.5 mg/dL or creatinine clearance > 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI)\n* Serum bilirubin =< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI\n* Serum glutamic oxaloacetic transaminase (SGPT) < 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI\n* No evidence of chronic active hepatitis or cirrhosis\n* Human immunodeficiency virus (HIV)-negative\n* Patient is not pregnant\n* Patient or guardian able to sign informed consent\n* DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry\n* DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP):\n\n  * Age of donor (18-24 > 25-34 > 35-44 > 45+)\n  * Sex of donor (male > female, nulliparous female > parous, multiparous female)\n  * Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- > CMV+\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators",
            "criterions": [
                {
                    "exact_snippets": "acute myeloid leukemia (AML)",
                    "criterion": "acute myeloid leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high risk myelodysplastic syndrome (MDS)",
                    "criterion": "high risk myelodysplastic syndrome",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undergoing second allogeneic (allo)-stem cell transplant (SCT)",
                    "criterion": "second allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "undergoing"
                        }
                    ]
                },
                {
                    "exact_snippets": "using the same donor or different donor",
                    "criterion": "donor type for stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "same donor",
                                "different donor"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "for disease relapse",
                    "criterion": "disease relapse",
                    "requirements": [
                        {
                            "requirement_type": "reason for transplant",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL)",
                    "criterion": "other hematologic malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "at the discretion of the investigators"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Karnofsky performance status of 70 or above",
            "criterions": [
                {
                    "exact_snippets": "Karnofsky performance status of 70 or above",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy is not severely limited by concomitant illness",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy is not severely limited by concomitant illness",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "limitation by concomitant illness",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate cardiac and pulmonary function; patients with decreased left ventricular ejection fraction (LVEF) =< 40% or diffusion capacity of carbon monoxide (DLCO) =< 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol",
            "criterions": [
                {
                    "exact_snippets": "Adequate cardiac ... function",
                    "criterion": "cardiac function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Adequate ... pulmonary function",
                    "criterion": "pulmonary function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "decreased left ventricular ejection fraction (LVEF) =< 40%",
                    "criterion": "left ventricular ejection fraction (LVEF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 40,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "diffusion capacity of carbon monoxide (DLCO) =< 50% of predicted",
                    "criterion": "diffusion capacity of carbon monoxide (DLCO)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<=",
                                "value": 50,
                                "unit": "% of predicted"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum creatinine =<1.5 mg/dL or creatinine clearance > 50 ml/min; some patients with minor deviations may be accepted on protocol after discussion with the principal investigator (PI)",
            "criterions": [
                {
                    "exact_snippets": "Serum creatinine =<1.5 mg/dL",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance > 50 ml/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum bilirubin =< 2.0 mg/dl; some patients with minor deviations may be accepted on protocol after discussion with the PI",
            "criterions": [
                {
                    "exact_snippets": "Serum bilirubin =< 2.0 mg/dl",
                    "criterion": "serum bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.0,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Serum glutamic oxaloacetic transaminase (SGPT) < 5 x upper limit of normal; some patients with minor deviations may be accepted on protocol after discussion with the PI",
            "criterions": [
                {
                    "exact_snippets": "Serum glutamic oxaloacetic transaminase (SGPT) < 5 x upper limit of normal",
                    "criterion": "serum glutamic oxaloacetic transaminase (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "x upper limit of normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No evidence of chronic active hepatitis or cirrhosis",
            "criterions": [
                {
                    "exact_snippets": "No evidence of chronic active hepatitis",
                    "criterion": "chronic active hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No evidence of ... cirrhosis",
                    "criterion": "cirrhosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Human immunodeficiency virus (HIV)-negative",
            "criterions": [
                {
                    "exact_snippets": "Human immunodeficiency virus (HIV)-negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is not pregnant",
            "criterions": [
                {
                    "exact_snippets": "Patient is not pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient or guardian able to sign informed consent",
            "criterions": [
                {
                    "exact_snippets": "Patient or guardian able to sign informed consent",
                    "criterion": "ability to sign informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: Since these patients already had first allo-SCT; in the majority time, the same matched donor has been used for second allo-SCT; if the patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT; the donor could be matched related donors or matched unrelated donors from registry",
            "criterions": [
                {
                    "exact_snippets": "patients already had first allo-SCT",
                    "criterion": "first allo-SCT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "same matched donor has been used for second allo-SCT",
                    "criterion": "same matched donor for second allo-SCT",
                    "requirements": [
                        {
                            "requirement_type": "usage",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients have multiple donors, alternative matched (8/8 or 10/10) donor could be used for the second allo-SCT",
                    "criterion": "alternative matched donor for second allo-SCT",
                    "requirements": [
                        {
                            "requirement_type": "matching",
                            "expected_value": [
                                "8/8",
                                "10/10"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "donor could be matched related donors or matched unrelated donors from registry",
                    "criterion": "donor type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "matched related donors",
                                "matched unrelated donors from registry"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* DONOR: If more than one potential volunteer unrelated donor is considered suitable, further selection of the most suitable donor will be prioritized as follows or will follow our institutional guideline from our stem cell transplant standard operating procedure (SOP):",
            "criterions": [
                {
                    "exact_snippets": "more than one potential volunteer unrelated donor is considered suitable",
                    "criterion": "volunteer unrelated donor",
                    "requirements": [
                        {
                            "requirement_type": "suitability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age of donor (18-24 > 25-34 > 35-44 > 45+)",
            "criterions": [
                {
                    "exact_snippets": "Age of donor (18-24 > 25-34 > 35-44 > 45+)",
                    "criterion": "age of donor",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 25,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 25,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 35,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 35,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 45,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Sex of donor (male > female, nulliparous female > parous, multiparous female)",
            "criterions": [
                {
                    "exact_snippets": "Sex of donor (male > female",
                    "criterion": "sex of donor",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "male > female"
                        }
                    ]
                },
                {
                    "exact_snippets": "nulliparous female > parous, multiparous female",
                    "criterion": "female donor parity",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "nulliparous > parous, multiparous"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cytomegalovirus (CMV) status, if recipient is CMV seronegative (CMV- > CMV+",
            "criterions": [
                {
                    "exact_snippets": "Cytomegalovirus (CMV) status",
                    "criterion": "Cytomegalovirus (CMV) status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "CMV seronegative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}