{
    "info": {
        "nct_id": "NCT04272957",
        "official_title": "A Phase I, Open-Label, Multicenter Study to Assess the Safety, Pharmacokinetics and Efficacy of HMPL-306 in Patients of Relapsed/Refractory Myeloid Leukemia/Neoplasms With IDH1 and/or IDH2 Mutation",
        "inclusion_criteria": "* ≥18 years of age;\n* Signed Informed Consent Form;\n* Relapsed/refractory Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia(CMML) and others myeloid neoplasm;\n* IDH1 and/or IDH2 mutated disease status as assessed by local laboratory;\n* Cooperative Oncology Group (ECOG) performance status of 0-2;\n* Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Previously treated with any prior IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy and had disease progression during treatment;\n* with known involvement or clinical symptoms of central nervous system (CNS);\n* Patients who have undergone HSCT within 60 days;\n* Without adequate liver or kidney function;\n* With known infection with active hepatitis B or C;\n* With known infection with human immunodeficiency virus (HIV);\n* History of clinically significant or active cardiac disease;\n* Active clinically significant infection;\n* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors;\n* Pregnancy or breast-feeding.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* ≥18 years of age;",
            "criterions": [
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Signed Informed Consent Form;",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent Form",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Relapsed/refractory Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia(CMML) and others myeloid neoplasm;",
            "criterions": [
                {
                    "exact_snippets": "Relapsed/refractory Acute myeloid leukemia (AML)",
                    "criterion": "Acute myeloid leukemia (AML)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myelodysplastic syndrome (MDS)",
                    "criterion": "myelodysplastic syndrome (MDS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic myelomonocytic leukemia(CMML)",
                    "criterion": "chronic myelomonocytic leukemia (CMML)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "others myeloid neoplasm",
                    "criterion": "myeloid neoplasm",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* IDH1 and/or IDH2 mutated disease status as assessed by local laboratory;",
            "criterions": [
                {
                    "exact_snippets": "IDH1 and/or IDH2 mutated disease status",
                    "criterion": "IDH1 and/or IDH2 mutation",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "mutated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cooperative Oncology Group (ECOG) performance status of 0-2;",
            "criterions": [
                {
                    "exact_snippets": "Cooperative Oncology Group (ECOG) performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects must be amenable to serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study.",
            "criterions": [
                {
                    "exact_snippets": "amenable to serial bone marrow biopsies",
                    "criterion": "amenability to bone marrow biopsies",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to ... peripheral blood sampling",
                    "criterion": "amenability to peripheral blood sampling",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "amenable to ... urine sampling",
                    "criterion": "amenability to urine sampling",
                    "requirements": [
                        {
                            "requirement_type": "amenability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Previously treated with any prior IDH1 inhibitor, IDH2 inhibitor, or IDH1/IDH2 double-targeted therapy and had disease progression during treatment;",
            "criterions": [
                {
                    "exact_snippets": "Previously treated with any prior IDH1 inhibitor",
                    "criterion": "prior IDH1 inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously treated with any prior ... IDH2 inhibitor",
                    "criterion": "prior IDH2 inhibitor treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Previously treated with any prior ... IDH1/IDH2 double-targeted therapy",
                    "criterion": "prior IDH1/IDH2 double-targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "had disease progression during treatment",
                    "criterion": "disease progression during treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* with known involvement or clinical symptoms of central nervous system (CNS);",
            "criterions": [
                {
                    "exact_snippets": "known involvement ... central nervous system (CNS)",
                    "criterion": "central nervous system involvement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinical symptoms of central nervous system (CNS)",
                    "criterion": "central nervous system symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone HSCT within 60 days;",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone HSCT within 60 days",
                    "criterion": "HSCT (Hematopoietic Stem Cell Transplantation)",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 60,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Without adequate liver or kidney function;",
            "criterions": [
                {
                    "exact_snippets": "adequate liver ... function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate ... kidney function",
                    "criterion": "kidney function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* With known infection with human immunodeficiency virus (HIV);",
            "criterions": [
                {
                    "exact_snippets": "known infection with human immunodeficiency virus (HIV)",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of clinically significant or active cardiac disease;",
            "criterions": [
                {
                    "exact_snippets": "History of clinically significant or active cardiac disease",
                    "criterion": "cardiac disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "activity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active clinically significant infection;",
            "criterions": [
                {
                    "exact_snippets": "Active clinically significant infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors;",
            "criterions": [
                {
                    "exact_snippets": "Taking known strong cytochrome P450 (CYP) 2C8 inducers or inhibitors",
                    "criterion": "CYP2C8 inducers or inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnancy or breast-feeding.",
            "criterions": [
                {
                    "exact_snippets": "Pregnancy",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breast-feeding",
                    "criterion": "breast-feeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* With known infection with active hepatitis B or C;",
            "criterions": [
                {
                    "exact_snippets": "known infection with active hepatitis B",
                    "criterion": "hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "known infection with active hepatitis C",
                    "criterion": "hepatitis C infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}