{
    "info": {
        "nct_id": "NCT06828991",
        "official_title": "CtDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients with Untreated DLBCL",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 70 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "Inclusion Criteria\n\n1. Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note. If 80 or older, the reason for dose-attenuated chemoimmunotherapy is assumed to be age.\n2. ECOG performance status of 0-2.\n3. Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma\n4. Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy but must not have received an anthracycline-containing regimen in the past.\n5. Composite and discordant lymphomas containing both indolent and large cell features will be included.\n6. Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions: a course of corticosteroids given for lymphoma related symptoms or one cycle of anthracycline containing chemotherapy prior to enrollment on the clinical trial. Pre-phase treatment with polatuzumab vedotin and steroids is allowable at the treating investigator's discretion.\n7. Ejection fraction of ≥ 45% on echocardiogram or MUGA\n8. Patient has a platelet count of ≥75,000/µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the platelet count should be ≥ 30,000/µL\n9. Patient has an absolute neutrophil count of ≥1,500/ µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the neutrophil count should be ≥500/ µL\n10. Patient has a calculated or measured creatinine clearance of >40 mL/minute within the screening period.\n11. Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome or hepatic involvement with aggressive B-cell lymphoma in which case it can be ≤ 3.0 times the ULN. ALT or AST must be ≤ 2.5 times the ULN.\n12. Patient has, with treatment in the opinion of the treating investigator, a life expectancy of at least 12 weeks.\n13. Signed Informed Consent Form\n14. Ability to comply with the study protocol\n\nExclusion Criteria\n\nPatients who meet any of the following exclusion criteria are not to be enrolled to this study:\n\n1. History of, or clinically apparent central nervous system (CNS) lymphoma\n2. Primary mediastinal B-cell lymphoma\n3. Patient is receiving peritoneal dialysis or hemodialysis\n4. Patient has > Grade 1 peripheral neuropathy.\n5. EF <45% or significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina\n6. Patient has received other investigational drugs within 28 days before enrollment.\n7. Prior exposure to anthracycline\n8. Patient has concomitant active malignancy that the treating physician or PI feels may interfere with the ability to measure the primary or secondary outcomes. Patients with stage 1 cancers are eligible after definitive treatment. Patients with low grade prostate cancer who are managed with observation are eligible. Patients with other malignancies that have been treated with curative intent may be included after discussion with the study PI.\n9. Participants who have a positive HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count >/= 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.\n10. Patient has active hepatitis B with a positive surface antigen or viral load. Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis throughout study participation according to national and local guidelines. Those at high risk of reactivation should be placed on appropriate antiviral therapy as per national guidelines.\n11. History of solid organ transplantation, or post-transplant lymphoproliferative disorder.\n12. Patient has history of allogeneic stem cell transplantation.\n13. Serious medical or psychiatric illness likely to interfere with participation in this clinical study including clinically significant CNS disease, active infections, or autoimmune disease that in the opinion of the treating investigator impacts their ability to safely participate in the clinical trial.\n14. Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention.\n15. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (>20 mg), azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents within 2 weeks prior to Day 1 of the first cycle of mosunetuzumab. The use of inhaled corticosteroids is permitted, as is the use of mineralocorticoids for management of orthostatic hypotension and a dose of dexamethasone 20mg or less for nausea or B symptoms."
    },
    "inclusion_lines": [
        {
            "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 70 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 70 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "1. Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note. If 80 or older, the reason for dose-attenuated chemoimmunotherapy is assumed to be age.",
            "criterions": [
                {
                    "exact_snippets": "Patients aged greater than or equal to 70 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 70,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ineligible for full-intensity chemoimmunotherapy",
                    "criterion": "eligibility for full-intensity chemoimmunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "at the discretion of the treating investigator",
                    "criterion": "discretion of the treating investigator",
                    "requirements": [
                        {
                            "requirement_type": "discretion",
                            "expected_value": "treating investigator"
                        }
                    ]
                },
                {
                    "exact_snippets": "If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note",
                    "criterion": "documentation of ineligibility reason",
                    "requirements": [
                        {
                            "requirement_type": "age range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 70,
                                        "unit": "years"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 79,
                                        "unit": "years"
                                    }
                                ]
                            }
                        },
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "If 80 or older, the reason for dose-attenuated chemoimmunotherapy is assumed to be age",
                    "criterion": "reason for dose-attenuated chemoimmunotherapy",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "years"
                            }
                        },
                        {
                            "requirement_type": "reason",
                            "expected_value": "age"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "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": "3. Histologically-confirmed DLBCL, NOS, high grade B-cell lymphoma with MYC and BCL2 rearrangements, high grade B-cell lymphoma, NOS, and grade 3b follicular lymphoma",
            "criterions": [
                {
                    "exact_snippets": "Histologically-confirmed DLBCL, NOS",
                    "criterion": "DLBCL, NOS",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically-confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "high grade B-cell lymphoma with MYC and BCL2 rearrangements",
                    "criterion": "high grade B-cell lymphoma with MYC and BCL2 rearrangements",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "high grade B-cell lymphoma, NOS",
                    "criterion": "high grade B-cell lymphoma, NOS",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "grade 3b follicular lymphoma",
                    "criterion": "grade 3b follicular lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Histologic transformation (HT) will be included on the study. This must be confirmed with a biopsy. Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy but must not have received an anthracycline-containing regimen in the past.",
            "criterions": [
                {
                    "exact_snippets": "Histologic transformation (HT) ... must be confirmed with a biopsy.",
                    "criterion": "histologic transformation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": "biopsy"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with HT may have received prior treatment for indolent lymphoma including chemoimmunotherapy",
                    "criterion": "prior treatment for indolent lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "chemoimmunotherapy"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "must not have received an anthracycline-containing regimen in the past",
                    "criterion": "anthracycline-containing regimen",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Composite and discordant lymphomas containing both indolent and large cell features will be included.",
            "criterions": [
                {
                    "exact_snippets": "Composite and discordant lymphomas containing both indolent and large cell features",
                    "criterion": "lymphoma type",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "composite",
                                "discordant"
                            ]
                        },
                        {
                            "requirement_type": "features",
                            "expected_value": [
                                "indolent",
                                "large cell"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has received no prior therapy for aggressive B-cell lymphoma or HT with the following exceptions: a course of corticosteroids given for lymphoma related symptoms or one cycle of anthracycline containing chemotherapy prior to enrollment on the clinical trial. Pre-phase treatment with polatuzumab vedotin and steroids is allowable at the treating investigator's discretion.",
            "criterions": [
                {
                    "exact_snippets": "Has received no prior therapy for aggressive B-cell lymphoma or HT",
                    "criterion": "prior therapy for aggressive B-cell lymphoma or HT",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "a course of corticosteroids given for lymphoma related symptoms",
                    "criterion": "course of corticosteroids for lymphoma related symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "one cycle of anthracycline containing chemotherapy prior to enrollment",
                    "criterion": "one cycle of anthracycline containing chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Pre-phase treatment with polatuzumab vedotin and steroids is allowable",
                    "criterion": "pre-phase treatment with polatuzumab vedotin and steroids",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Ejection fraction of ≥ 45% on echocardiogram or MUGA",
            "criterions": [
                {
                    "exact_snippets": "Ejection fraction of ≥ 45%",
                    "criterion": "ejection fraction",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient has a platelet count of ≥75,000/µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the platelet count should be ≥ 30,000/µL",
            "criterions": [
                {
                    "exact_snippets": "platelet count of ≥75,000/µL within the screening period",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 75000,
                                "unit": "/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platelet count should be ≥ 30,000/µL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30000,
                                "unit": "/µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma",
                    "criterion": "bone marrow infiltration with aggressive B-cell lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "cause of inadequate function",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Patient has an absolute neutrophil count of ≥1,500/ µL within the screening period unless inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma in which case the neutrophil count should be ≥500/ µL",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count of ≥1,500/ µL within the screening period",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "/ µL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "inadequate function is due to bone marrow infiltration with aggressive B-cell lymphoma ... neutrophil count should be ≥500/ µL",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "/ µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patient has a calculated or measured creatinine clearance of >40 mL/minute within the screening period.",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance of >40 mL/minute",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/minute"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Total bilirubin must be less than 1.5 times the upper limit of normal (ULN) unless the elevation is known to be due to Gilbert syndrome or hepatic involvement with aggressive B-cell lymphoma in which case it can be ≤ 3.0 times the ULN. ALT or AST must be ≤ 2.5 times the ULN.",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin must be less than 1.5 times the upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless the elevation is known to be due to Gilbert syndrome or hepatic involvement with aggressive B-cell lymphoma",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "condition",
                            "expected_value": [
                                "Gilbert syndrome",
                                "hepatic involvement with aggressive B-cell lymphoma"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in which case it can be ≤ 3.0 times the ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3.0,
                                "unit": "times ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT or AST must be ≤ 2.5 times the ULN",
                    "criterion": "ALT or AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "times ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patient has, with treatment in the opinion of the treating investigator, a life expectancy of at least 12 weeks.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 12 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 12,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Signed Informed Consent Form",
            "criterions": [
                {
                    "exact_snippets": "Signed Informed Consent Form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Ability to comply with the study protocol",
            "criterions": [
                {
                    "exact_snippets": "Ability to comply with the study protocol",
                    "criterion": "compliance with study protocol",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. History of, or clinically apparent central nervous system (CNS) lymphoma",
            "criterions": [
                {
                    "exact_snippets": "History of, or clinically apparent central nervous system (CNS) lymphoma",
                    "criterion": "central nervous system (CNS) lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Primary mediastinal B-cell lymphoma",
            "criterions": [
                {
                    "exact_snippets": "Primary mediastinal B-cell lymphoma",
                    "criterion": "primary mediastinal B-cell lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Patient is receiving peritoneal dialysis or hemodialysis",
            "criterions": [
                {
                    "exact_snippets": "Patient is receiving peritoneal dialysis",
                    "criterion": "peritoneal dialysis",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient is receiving ... hemodialysis",
                    "criterion": "hemodialysis",
                    "requirements": [
                        {
                            "requirement_type": "receiving",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Patient has > Grade 1 peripheral neuropathy.",
            "criterions": [
                {
                    "exact_snippets": "Patient has > Grade 1 peripheral neuropathy.",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. EF <45% or significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina",
            "criterions": [
                {
                    "exact_snippets": "EF <45%",
                    "criterion": "ejection fraction (EF)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 45,
                                "unit": "%"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "significant or extensive history of cardiovascular disease",
                    "criterion": "history of cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "significant",
                                "extensive"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "New York Heart Association Class III or IV cardiac disease",
                    "criterion": "New York Heart Association cardiac disease class",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "III",
                                "IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Objective Assessment Class C or D",
                    "criterion": "Objective Assessment cardiac disease class",
                    "requirements": [
                        {
                            "requirement_type": "class",
                            "expected_value": [
                                "C",
                                "D"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within the last 6 months prior to the start of Cycle 1",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable arrhythmias",
                    "criterion": "arrhythmias",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "angina",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patient has received other investigational drugs within 28 days before enrollment.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received other investigational drugs within 28 days before enrollment.",
                    "criterion": "receipt of investigational drugs",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Prior exposure to anthracycline",
            "criterions": [
                {
                    "exact_snippets": "Prior exposure to anthracycline",
                    "criterion": "anthracycline exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Patient has concomitant active malignancy that the treating physician or PI feels may interfere with the ability to measure the primary or secondary outcomes. Patients with stage 1 cancers are eligible after definitive treatment. Patients with low grade prostate cancer who are managed with observation are eligible. Patients with other malignancies that have been treated with curative intent may be included after discussion with the study PI.",
            "criterions": [
                {
                    "exact_snippets": "concomitant active malignancy",
                    "criterion": "concomitant active malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "stage 1 cancers",
                    "criterion": "stage 1 cancers",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "low grade prostate cancer",
                    "criterion": "low grade prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "management",
                            "expected_value": "observation"
                        }
                    ]
                },
                {
                    "exact_snippets": "other malignancies ... treated with curative intent",
                    "criterion": "other malignancies treated with curative intent",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Participants who have a positive HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count >/= 200/uL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months.",
            "criterions": [
                {
                    "exact_snippets": "positive HIV test at screening",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable on anti-retroviral therapy for at least 4 weeks",
                    "criterion": "anti-retroviral therapy stability",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "CD4 count >/= 200/uL",
                    "criterion": "CD4 count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 200,
                                "unit": "uL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable viral load",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "not had a history of opportunistic infection attributable to AIDS within the last 12 months",
                    "criterion": "history of opportunistic infection",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": ">",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Patient has active hepatitis B with a positive surface antigen or viral load. Carriers of hepatitis B virus should be closely monitored for clinical and laboratory signs of active HBV infection and for signs of hepatitis throughout study participation according to national and local guidelines. Those at high risk of reactivation should be placed on appropriate antiviral therapy as per national guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Patient has active hepatitis B",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "positive surface antigen",
                    "criterion": "hepatitis B surface antigen",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "viral load",
                    "criterion": "hepatitis B viral load",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. History of solid organ transplantation, or post-transplant lymphoproliferative disorder.",
            "criterions": [
                {
                    "exact_snippets": "History of solid organ transplantation",
                    "criterion": "solid organ transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "post-transplant lymphoproliferative disorder",
                    "criterion": "post-transplant lymphoproliferative disorder",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Patient has history of allogeneic stem cell transplantation.",
            "criterions": [
                {
                    "exact_snippets": "history of allogeneic stem cell transplantation",
                    "criterion": "allogeneic stem cell transplantation",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Serious medical or psychiatric illness likely to interfere with participation in this clinical study including clinically significant CNS disease, active infections, or autoimmune disease that in the opinion of the treating investigator impacts their ability to safely participate in the clinical trial.",
            "criterions": [
                {
                    "exact_snippets": "Serious medical or psychiatric illness likely to interfere with participation",
                    "criterion": "serious medical or psychiatric illness",
                    "requirements": [
                        {
                            "requirement_type": "interference with participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant CNS disease",
                    "criterion": "CNS disease",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "active infections",
                    "criterion": "active infections",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune disease that in the opinion of the treating investigator impacts their ability to safely participate",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "impact on ability to safely participate",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Any clinically significant abnormality in screening blood chemistry, hematology, or urinalysis results that, in the judgment of the investigator, would impede adequate evaluation of adverse events and/or response to treatment, or that requires aggressive intervention.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant abnormality in screening blood chemistry",
                    "criterion": "blood chemistry",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormality in screening ... hematology",
                    "criterion": "hematology",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "clinically significant abnormality in screening ... urinalysis results",
                    "criterion": "urinalysis",
                    "requirements": [
                        {
                            "requirement_type": "abnormality",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (>20 mg), azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents within 2 weeks prior to Day 1 of the first cycle of mosunetuzumab. The use of inhaled corticosteroids is permitted, as is the use of mineralocorticoids for management of orthostatic hypotension and a dose of dexamethasone 20mg or less for nausea or B symptoms.",
            "criterions": [
                {
                    "exact_snippets": "Treatment with systemic immunosuppressive medications, including, but not limited to, prednisone (>20 mg), azathioprine, methotrexate, thalidomide, and antitumor necrosis factor agents within 2 weeks prior to Day 1 of the first cycle of mosunetuzumab.",
                    "criterion": "systemic immunosuppressive medications",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "The use of inhaled corticosteroids is permitted",
                    "criterion": "inhaled corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "the use of mineralocorticoids for management of orthostatic hypotension",
                    "criterion": "mineralocorticoids",
                    "requirements": [
                        {
                            "requirement_type": "use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "a dose of dexamethasone 20mg or less for nausea or B symptoms",
                    "criterion": "dexamethasone",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 20,
                                "unit": "mg"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "Inclusion Criteria",
            "criterions": []
        },
        {
            "line": "Exclusion Criteria",
            "criterions": []
        },
        {
            "line": "Patients who meet any of the following exclusion criteria are not to be enrolled to this study:",
            "criterions": []
        }
    ]
}