{
    "info": {
        "nct_id": "NCT00989261",
        "official_title": "Phase 2 Open-Label, AC220 Monotherapy Efficacy (ACE) Study in Patients With Acute Myeloid Leukemia (AML) With and Without FLT3-ITD Activating Mutations",
        "inclusion_criteria": "1. Males and females age ≥18 years in second relapse or refractory.\n2. Males and females age ≥60 years in first relapse or refractory.\n3. Must have baseline bone marrow sample taken.\n4. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.\n5. Able to swallow the liquid study drug.\n6. Eastern Cooperative Oncology Group performance status of 0 to 2\n7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.\n8. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1.\n9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.\n10. Serum creatinine ≤1.5 × upper limit of normal (ULN) and glomerular filtration rate (GFR) > 30 mL/min\n11. Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.\n12. Total serum bilirubin ≤1.5 × ULN\n13. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN\n14. Females of childbearing potential must have a negative pregnancy test (urine β-hCG).\n15. Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.\n16. Written informed consent must be provided.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 85 Years",
        "exclusion_criteria": "1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.\n2. Diagnosis of acute promyelocytic leukemia\n3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis\n4. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment\n5. AML or antecedent MDS secondary to prior chemotherapy\n6. Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy\n7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant\n8. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.\n9. Patients who have previously received AC220\n10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)\n11. Major surgery within 4 weeks prior to enrollment in the study\n12. Radiation therapy within 4 weeks prior to, or concurrent with study\n13. Use of concomitant drugs that prolong the time between the start of the Q wave and the end of the T wave (QT)/corrected interval between the Q wave and T wave (QTc) interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.\n14. Uncontrolled or significant cardiovascular disease\n15. Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential\n16. Men who are unwilling to use contraception if their partners are of childbearing potential\n17. Active, uncontrolled infection\n18. Human immunodeficiency virus positivity\n19. Active hepatitis B or C or other active liver disease\n20. History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission",
        "miscellaneous_criteria": "Current enrollment is open only to FLT3-ITD positive, Cohort 1."
    },
    "inclusion_lines": [
        {
            "line": "1. Males and females age ≥18 years in second relapse or refractory.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Males and females"
                    ],
                    "criterion": "gender",
                    "requirement_type": "inclusion",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                },
                {
                    "exact_snippets": [
                        "age ≥18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                },
                {
                    "exact_snippets": [
                        "second relapse"
                    ],
                    "criterion": "relapse",
                    "requirement_type": "count",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "refractory"
                    ],
                    "criterion": "refractory",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "2. Males and females age ≥60 years in first relapse or refractory.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Males and females"
                    ],
                    "criterion": "gender",
                    "requirement_type": "inclusion",
                    "expected_value": [
                        "male",
                        "female"
                    ]
                },
                {
                    "exact_snippets": [
                        "age ≥60 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 60
                    }
                },
                {
                    "exact_snippets": [
                        "first relapse"
                    ],
                    "criterion": "relapse",
                    "requirement_type": "occurrence",
                    "expected_value": "first"
                },
                {
                    "exact_snippets": [
                        "refractory"
                    ],
                    "criterion": "refractory",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Must have baseline bone marrow sample taken.",
            "criterions": [
                {
                    "exact_snippets": [
                        "baseline bone marrow sample taken"
                    ],
                    "criterion": "bone marrow sample",
                    "requirement_type": "baseline",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "4. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Morphologically documented primary AML"
                    ],
                    "criterion": "primary AML",
                    "requirement_type": "documentation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "AML secondary to myelodysplastic syndrome"
                    ],
                    "criterion": "AML secondary to myelodysplastic syndrome",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "MDS with ≥20% bone marrow or peripheral blasts"
                    ],
                    "criterion": "MDS",
                    "requirement_type": "blast percentage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 20
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "as defined by the World Health Organization (WHO) criteria"
                    ],
                    "criterion": "WHO criteria",
                    "requirement_type": "definition",
                    "expected_value": "World Health Organization"
                },
                {
                    "exact_snippets": [
                        "confirmed by pathology review at treating institution"
                    ],
                    "criterion": "pathology review",
                    "requirement_type": "confirmation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "5. Able to swallow the liquid study drug.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Able to swallow"
                    ],
                    "criterion": "swallowing ability",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "6. Eastern Cooperative Oncology Group performance status of 0 to 2",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group performance status of 0 to 2"
                    ],
                    "criterion": "Eastern Cooperative Oncology Group performance status",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 0
                            },
                            {
                                "operator": "<=",
                                "value": 2
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "7. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": [
                        "absence of rapidly progressing disease"
                    ],
                    "criterion": "rapidly progressing disease",
                    "requirement_type": "absence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "interval from prior treatment to time of AC220 administration",
                        "at least 2 weeks",
                        "cytotoxic agents"
                    ],
                    "criterion": "interval from prior treatment to AC220 administration",
                    "requirement_type": "minimum duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "interval from prior treatment to time of AC220 administration",
                        "at least 5 half-lives",
                        "noncytotoxic agents"
                    ],
                    "criterion": "interval from prior treatment to AC220 administration",
                    "requirement_type": "minimum duration",
                    "expected_value": "at least 5 half-lives for noncytotoxic agents"
                },
                {
                    "exact_snippets": [
                        "use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted"
                    ],
                    "criterion": "use of chemotherapeutic or antileukemic agents",
                    "requirement_type": "restriction",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "possible exception of intrathecal (IT) therapy",
                        "at the discretion of the Investigator",
                        "with the agreement of the Sponsor"
                    ],
                    "criterion": "intrathecal (IT) therapy",
                    "requirement_type": "conditional allowance",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "8. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Persistent chronic clinically significant non-hematological toxicities from prior treatment"
                    ],
                    "criterion": "non-hematological toxicities",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "9. Prior therapy with FLT3 inhibitors is permitted, except previous treatment with AC220.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior therapy with FLT3 inhibitors"
                    ],
                    "criterion": "FLT3 inhibitors",
                    "requirement_type": "prior therapy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "except previous treatment with AC220"
                    ],
                    "criterion": "AC220",
                    "requirement_type": "prior therapy",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "10. Serum creatinine ≤1.5 × upper limit of normal (ULN) and glomerular filtration rate (GFR) > 30 mL/min",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum creatinine ≤1.5 × upper limit of normal (ULN)"
                    ],
                    "criterion": "serum creatinine",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "glomerular filtration rate (GFR) > 30 mL/min"
                    ],
                    "criterion": "glomerular filtration rate",
                    "requirement_type": "rate",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "11. Serum potassium, magnesium, and calcium levels should be at least within institutional normal limits.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum potassium",
                        "levels should be at least within institutional normal limits"
                    ],
                    "criterion": "serum potassium",
                    "requirement_type": "level",
                    "expected_value": "at least within institutional normal limits"
                },
                {
                    "exact_snippets": [
                        "magnesium",
                        "levels should be at least within institutional normal limits"
                    ],
                    "criterion": "magnesium",
                    "requirement_type": "level",
                    "expected_value": "at least within institutional normal limits"
                },
                {
                    "exact_snippets": [
                        "calcium",
                        "levels should be at least within institutional normal limits"
                    ],
                    "criterion": "calcium",
                    "requirement_type": "level",
                    "expected_value": "at least within institutional normal limits"
                }
            ]
        },
        {
            "line": "12. Total serum bilirubin ≤1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": [
                        "Total serum bilirubin ≤1.5 × ULN"
                    ],
                    "criterion": "total serum bilirubin",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 1.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "13. Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) ≤2.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": [
                        "Serum aspartate transaminase (AST)",
                        "≤2.5 × ULN"
                    ],
                    "criterion": "serum aspartate transaminase (AST)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.5
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "alanine transaminase (ALT)",
                        "≤2.5 × ULN"
                    ],
                    "criterion": "alanine transaminase (ALT)",
                    "requirement_type": "level",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 2.5
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "14. Females of childbearing potential must have a negative pregnancy test (urine β-hCG).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Females of childbearing potential"
                    ],
                    "criterion": "female",
                    "requirement_type": "childbearing potential",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                }
            ]
        },
        {
            "line": "15. Females of childbearing potential and sexually mature males must agree to use a medically accepted method of contraception throughout the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Females of childbearing potential"
                    ],
                    "criterion": "females of childbearing potential",
                    "requirement_type": "agreement to use contraception",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "sexually mature males"
                    ],
                    "criterion": "sexually mature males",
                    "requirement_type": "agreement to use contraception",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "16. Written informed consent must be provided.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Written informed consent must be provided"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "provision",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        },
        {
            "line": "Must have maximum age of 85 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "maximum age of 85 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "maximum",
                    "expected_value": {
                        "operator": "<=",
                        "value": 85
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients over the age of 85 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "range",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 85
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "2. Diagnosis of acute promyelocytic leukemia",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosis of acute promyelocytic leukemia"
                    ],
                    "criterion": "acute promyelocytic leukemia",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "3. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis",
            "criterions": [
                {
                    "exact_snippets": [
                        "Diagnosis of chronic myelogenous leukemia (CML)"
                    ],
                    "criterion": "chronic myelogenous leukemia (CML)",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "blast crisis"
                    ],
                    "criterion": "blast crisis",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "4. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment",
            "criterions": [
                {
                    "exact_snippets": [
                        "AML in relapse or refractory"
                    ],
                    "criterion": "AML",
                    "requirement_type": "status",
                    "expected_value": [
                        "relapse",
                        "refractory"
                    ]
                },
                {
                    "exact_snippets": [
                        "3 or more previous lines of chemotherapy (and/or HSCT) treatment"
                    ],
                    "criterion": "previous treatment lines",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 3
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "5. AML or antecedent MDS secondary to prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "AML"
                    ],
                    "criterion": "AML",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "antecedent MDS secondary to prior chemotherapy"
                    ],
                    "criterion": "antecedent MDS",
                    "requirement_type": "cause",
                    "expected_value": "secondary to prior chemotherapy"
                }
            ]
        },
        {
            "line": "6. Persistent clinically significant non-hematological toxicity that is Grade >1 by NCI CTCAE v4 from prior chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Persistent clinically significant non-hematological toxicity"
                    ],
                    "criterion": "non-hematological toxicity",
                    "requirement_type": "persistence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Persistent clinically significant non-hematological toxicity"
                    ],
                    "criterion": "non-hematological toxicity",
                    "requirement_type": "clinical significance",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Grade >1",
                        "NCI CTCAE v4"
                    ],
                    "criterion": "non-hematological toxicity",
                    "requirement_type": "grade",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 1
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "from prior chemotherapy"
                    ],
                    "criterion": "prior chemotherapy",
                    "requirement_type": "association",
                    "expected_value": "non-hematological toxicity"
                }
            ]
        },
        {
            "line": "7. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have >Grade 1 persistent non hematological toxicity related to the transplant",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who have had HSCT"
                    ],
                    "criterion": "HSCT",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 100 days of transplant"
                    ],
                    "criterion": "days since transplant",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 100
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "still taking immunosuppressive drugs"
                    ],
                    "criterion": "immunosuppressive drugs",
                    "requirement_type": "current use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "clinically significant graft-versus-host disease requiring treatment"
                    ],
                    "criterion": "graft-versus-host disease",
                    "requirement_type": "severity",
                    "expected_value": "clinically significant requiring treatment"
                },
                {
                    "exact_snippets": [
                        ">Grade 1 persistent non hematological toxicity related to the transplant"
                    ],
                    "criterion": "non hematological toxicity related to the transplant",
                    "requirement_type": "severity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 1
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "8. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Clinically active central nervous system (CNS) leukemia"
                    ],
                    "criterion": "central nervous system leukemia",
                    "requirement_type": "activity",
                    "expected_value": "clinically active"
                },
                {
                    "exact_snippets": [
                        "Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy"
                    ],
                    "criterion": "CNS leukemia",
                    "requirement_type": "control",
                    "expected_value": "controlled"
                },
                {
                    "exact_snippets": [
                        "Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy"
                    ],
                    "criterion": "IT therapy",
                    "requirement_type": "receipt",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "9. Patients who have previously received AC220",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who have previously received AC220"
                    ],
                    "criterion": "AC220",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "10. Disseminated intravascular coagulation (DIC) (diagnosis by laboratory or clinical assessment)",
            "criterions": [
                {
                    "exact_snippets": [
                        "Disseminated intravascular coagulation (DIC)"
                    ],
                    "criterion": "disseminated intravascular coagulation",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "11. Major surgery within 4 weeks prior to enrollment in the study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Major surgery within 4 weeks prior to enrollment"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "12. Radiation therapy within 4 weeks prior to, or concurrent with study",
            "criterions": [
                {
                    "exact_snippets": [
                        "Radiation therapy within 4 weeks prior to"
                    ],
                    "criterion": "radiation therapy",
                    "requirement_type": "timing",
                    "expected_value": "within 4 weeks prior to study"
                },
                {
                    "exact_snippets": [
                        "Radiation therapy",
                        "concurrent with study"
                    ],
                    "criterion": "radiation therapy",
                    "requirement_type": "timing",
                    "expected_value": "concurrent with study"
                }
            ]
        },
        {
            "line": "13. Use of concomitant drugs that prolong the time between the start of the Q wave and the end of the T wave (QT)/corrected interval between the Q wave and T wave (QTc) interval and/or are CYP3A4 inhibitors are prohibited with the exception of antibiotics, antifungals, and other antimicrobials that are used as standard of care to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the patient.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Use of concomitant drugs that prolong the time between the start of the Q wave and the end of the T wave (QT)/corrected interval between the Q wave and T wave (QTc) interval"
                    ],
                    "criterion": "concomitant drugs",
                    "requirement_type": "prolongation of QT/QTc interval",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Use of concomitant drugs that",
                        "are CYP3A4 inhibitors"
                    ],
                    "criterion": "concomitant drugs",
                    "requirement_type": "CYP3A4 inhibition",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "14. Uncontrolled or significant cardiovascular disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Uncontrolled or significant cardiovascular disease"
                    ],
                    "criterion": "cardiovascular disease",
                    "requirement_type": "control",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "Uncontrolled or significant cardiovascular disease"
                    ],
                    "criterion": "cardiovascular disease",
                    "requirement_type": "severity",
                    "expected_value": "significant"
                }
            ]
        },
        {
            "line": "15. Women who are pregnant, lactating, or unwilling to use contraception if of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women who are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "lactating"
                    ],
                    "criterion": "lactation",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "unwilling to use contraception",
                        "if of childbearing potential"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "willingness",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "16. Men who are unwilling to use contraception if their partners are of childbearing potential",
            "criterions": [
                {
                    "exact_snippets": [
                        "Men who are unwilling to use contraception"
                    ],
                    "criterion": "contraception use",
                    "requirement_type": "willingness",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "partners are of childbearing potential"
                    ],
                    "criterion": "partner's childbearing potential",
                    "requirement_type": "status",
                    "expected_value": "childbearing potential"
                }
            ]
        },
        {
            "line": "17. Active, uncontrolled infection",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active, uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "control status",
                    "expected_value": "uncontrolled"
                },
                {
                    "exact_snippets": [
                        "Active, uncontrolled infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "activity status",
                    "expected_value": "active"
                }
            ]
        },
        {
            "line": "18. Human immunodeficiency virus positivity",
            "criterions": [
                {
                    "exact_snippets": [
                        "Human immunodeficiency virus positivity"
                    ],
                    "criterion": "human immunodeficiency virus",
                    "requirement_type": "positivity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "20. History of cancer, except Stage 1 cervix or nonmelanotic skin cancer, with the possible exception of patients in complete remission",
            "criterions": [
                {
                    "exact_snippets": [
                        "History of cancer"
                    ],
                    "criterion": "cancer",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Stage 1 cervix"
                    ],
                    "criterion": "cervix cancer",
                    "requirement_type": "stage",
                    "expected_value": "1"
                },
                {
                    "exact_snippets": [
                        "nonmelanotic skin cancer"
                    ],
                    "criterion": "skin cancer",
                    "requirement_type": "type",
                    "expected_value": "nonmelanotic"
                },
                {
                    "exact_snippets": [
                        "patients in complete remission"
                    ],
                    "criterion": "cancer",
                    "requirement_type": "remission status",
                    "expected_value": "complete remission"
                }
            ]
        }
    ],
    "miscellaneous_lines": [
        {
            "line": "Current enrollment is open only to FLT3-ITD positive, Cohort 1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "FLT3-ITD positive"
                    ],
                    "criterion": "FLT3-ITD",
                    "requirement_type": "status",
                    "expected_value": "positive"
                },
                {
                    "exact_snippets": [
                        "Cohort 1"
                    ],
                    "criterion": "cohort",
                    "requirement_type": "assignment",
                    "expected_value": "1"
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "19. Active hepatitis B or C or other active liver disease",
            "criterions": [
                {
                    "exact_snippets": [
                        "Active hepatitis B"
                    ],
                    "criterion": "hepatitis B",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Active hepatitis C"
                    ],
                    "criterion": "hepatitis C",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "other active liver disease"
                    ],
                    "criterion": "liver disease",
                    "requirement_type": "activity",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}