{
    "info": {
        "nct_id": "NCT02867618",
        "official_title": "Phase I/II Study of Carfilzomib and a PI3Kdelta Inhibitor TGR-1202 in the Treatment of Patients With Relapsed or Refractory Lymphoma",
        "inclusion_criteria": "* Phase I: Patients must have histologically confirmed R/R NHL or HL (defined by World Health Organization (WHO) criteria). Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible. In addition, patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL and HL will be eligible if there is no available standard therapy.\n* Phase II: Patients must have histologically confirmed R/R NHL (as defined by WHO criteria). Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL will be eligible if there is no available standard therapy.\n* Must have received front line chemotherapy. No upper limit for the number of prior therapies\n* Evaluable Disease in the Phase I, and measurable disease in the Phase II\n* Age > 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status < 2\n* Patients must have adequate organ and marrow function\n* Adequate Contraception\n* Ability to understand and the willingness to sign a written informed consent document\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Prior Therapy Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. No other investigational agents are allowed.\n2. History of allergic reactions to TGR-1202 or carfilzomib\n3. Uncontrolled inter-current illness\n4. Pregnant women\n5. Nursing women\n6. Current malignancy or history of a prior malignancy\n7. Patient known to be Human Immunodeficiency Virus (HIV)-positive\n8. Active Hepatitis A, Hepatitis B, or Hepatitis C infection",
        "miscellaneous_criteria": "Target Population Phase I: Patients with relapsed or refractory NHL and HL Phase II: Patients with relapsed or refractory NHL"
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "* Phase I: Patients must have histologically confirmed R/R NHL or HL (defined by World Health Organization (WHO) criteria). Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible. In addition, patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL and HL will be eligible if there is no available standard therapy.",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed R/R NHL or HL",
                        "criterion": "histological confirmation",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible",
                        "criterion": "chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies",
                        "criterion": "prior therapies for NHL other than DLBCL",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "therapies"
                            }
                        }
                    },
                    {
                        "exact_snippets": "DLBCL and HL will be eligible if there is no available standard therapy",
                        "criterion": "availability of standard therapy for DLBCL and HL",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "histologically confirmed R/R NHL or HL",
                                        "criterion": "histological confirmation",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "or_criteria": [
                                            {
                                                "exact_snippets": "chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible",
                                                "criterion": "chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)",
                                                "requirement": {
                                                    "requirement_type": "eligibility",
                                                    "expected_value": true
                                                }
                                            },
                                            {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies",
                                                        "criterion": "prior therapies for NHL other than DLBCL",
                                                        "requirement": {
                                                            "requirement_type": "quantity",
                                                            "expected_value": {
                                                                "operator": ">=",
                                                                "value": 2,
                                                                "unit": "therapies"
                                                            }
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "histologically confirmed R/R NHL or HL",
                                                        "criterion": "histological confirmation",
                                                        "requirement": {
                                                            "requirement_type": "presence",
                                                            "expected_value": true
                                                        }
                                                    }
                                                ]
                                            }
                                        ]
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "histologically confirmed R/R NHL or HL",
                                        "criterion": "histological confirmation",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "DLBCL and HL will be eligible if there is no available standard therapy",
                                        "criterion": "availability of standard therapy for DLBCL and HL",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Phase II: Patients must have histologically confirmed R/R NHL (as defined by WHO criteria). Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies. Patients with DLBCL will be eligible if there is no available standard therapy.",
                "criterions": [
                    {
                        "exact_snippets": "histologically confirmed R/R NHL (as defined by WHO criteria)",
                        "criterion": "R/R NHL",
                        "requirement": {
                            "requirement_type": "confirmation",
                            "expected_value": "histologically confirmed"
                        }
                    },
                    {
                        "exact_snippets": "histologically confirmed R/R NHL (as defined by WHO criteria)",
                        "criterion": "R/R NHL",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "WHO criteria"
                        }
                    },
                    {
                        "exact_snippets": "Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies",
                        "criterion": "prior therapies for NHL other than DLBCL",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "therapies"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Patients with DLBCL will be eligible if there is no available standard therapy",
                        "criterion": "availability of standard therapy for DLBCL",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "histologically confirmed R/R NHL (as defined by WHO criteria)",
                                "criterion": "R/R NHL",
                                "requirement": {
                                    "requirement_type": "confirmation",
                                    "expected_value": "histologically confirmed"
                                }
                            },
                            {
                                "exact_snippets": "histologically confirmed R/R NHL (as defined by WHO criteria)",
                                "criterion": "R/R NHL",
                                "requirement": {
                                    "requirement_type": "definition",
                                    "expected_value": "WHO criteria"
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies",
                                        "criterion": "prior therapies for NHL other than DLBCL",
                                        "requirement": {
                                            "requirement_type": "quantity",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 2,
                                                "unit": "therapies"
                                            }
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Patients with DLBCL will be eligible if there is no available standard therapy",
                                        "criterion": "availability of standard therapy for DLBCL",
                                        "requirement": {
                                            "requirement_type": "availability",
                                            "expected_value": false
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Must have received front line chemotherapy. No upper limit for the number of prior therapies",
                "criterions": [
                    {
                        "exact_snippets": "Must have received front line chemotherapy",
                        "criterion": "front line chemotherapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No upper limit for the number of prior therapies",
                        "criterion": "number of prior therapies",
                        "requirement": {
                            "requirement_type": "upper limit",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must have received front line chemotherapy",
                        "criterion": "front line chemotherapy",
                        "requirement": {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "No upper limit for the number of prior therapies",
                        "criterion": "number of prior therapies",
                        "requirement": {
                            "requirement_type": "upper limit",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evaluable Disease in the Phase I, and measurable disease in the Phase II",
                "criterions": [
                    {
                        "exact_snippets": "Evaluable Disease in the Phase I",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "evaluability",
                            "expected_value": "evaluable"
                        }
                    },
                    {
                        "exact_snippets": "Evaluable Disease in the Phase I",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "I"
                        }
                    },
                    {
                        "exact_snippets": "measurable disease in the Phase II",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": "measurable"
                        }
                    },
                    {
                        "exact_snippets": "measurable disease in the Phase II",
                        "criterion": "disease",
                        "requirement": {
                            "requirement_type": "phase",
                            "expected_value": "II"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Evaluable Disease in the Phase I",
                                    "criterion": "disease",
                                    "requirement": {
                                        "requirement_type": "phase",
                                        "expected_value": "I"
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "Evaluable Disease in the Phase I",
                                    "criterion": "disease",
                                    "requirement": {
                                        "requirement_type": "evaluability",
                                        "expected_value": "evaluable"
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    },
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "measurable disease in the Phase II",
                                    "criterion": "disease",
                                    "requirement": {
                                        "requirement_type": "phase",
                                        "expected_value": "II"
                                    }
                                }
                            ]
                        },
                        "then_criteria": {
                            "and_criteria": [
                                {
                                    "exact_snippets": "measurable disease in the Phase II",
                                    "criterion": "disease",
                                    "requirement": {
                                        "requirement_type": "measurability",
                                        "expected_value": "measurable"
                                    }
                                }
                            ]
                        },
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age > 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age > 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Eastern Cooperative Oncology Group (ECOG) performance status < 2",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status < 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status < 2",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Patients must have adequate organ and marrow function",
                "criterions": [
                    {
                        "exact_snippets": "adequate organ and marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate organ and marrow function",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "adequate organ and marrow function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "adequate organ and marrow function",
                        "criterion": "marrow function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Adequate Contraception",
                "criterions": [
                    {
                        "exact_snippets": "Adequate Contraception",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate Contraception",
                        "criterion": "contraception",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to understand and the willingness to sign a written informed consent document",
                "criterions": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Ability to understand",
                        "criterion": "cognitive ability",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "willingness to sign a written informed consent document",
                        "criterion": "willingness to consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Prior Therapy Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. No other investigational agents are allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study",
                        "criterion": "prior chemotherapy or radiotherapy",
                        "requirement": {
                            "requirement_type": "time since exposure",
                            "expected_value": {
                                "operator": "<",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    },
                    {
                        "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 2 weeks earlier",
                        "criterion": "recovery from adverse events",
                        "requirement": {
                            "requirement_type": "recovery status",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs",
                        "criterion": "systemic steroids",
                        "requirement": {
                            "requirement_type": "stabilization duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs",
                        "criterion": "systemic steroids",
                        "requirement": {
                            "requirement_type": "prednisone equivalent dosage",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day"
                            }
                        }
                    },
                    {
                        "exact_snippets": "No other investigational agents are allowed",
                        "criterion": "use of investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study",
                                "criterion": "prior chemotherapy or radiotherapy",
                                "requirement": {
                                    "requirement_type": "time since exposure",
                                    "expected_value": {
                                        "operator": "<",
                                        "value": 2,
                                        "unit": "weeks"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "those who have not recovered from adverse events due to agents administered more than 2 weeks earlier",
                                "criterion": "recovery from adverse events",
                                "requirement": {
                                    "requirement_type": "recovery status",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs",
                                "criterion": "systemic steroids",
                                "requirement": {
                                    "requirement_type": "stabilization duration",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "days"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Systemic steroids that have not been stabilized (≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs",
                                "criterion": "systemic steroids",
                                "requirement": {
                                    "requirement_type": "prednisone equivalent dosage",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 10,
                                        "unit": "mg/day"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "No other investigational agents are allowed",
                        "criterion": "use of investigational agents",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. History of allergic reactions to TGR-1202 or carfilzomib",
                "criterions": [
                    {
                        "exact_snippets": "History of allergic reactions to TGR-1202",
                        "criterion": "allergic reactions to TGR-1202",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions to ... carfilzomib",
                        "criterion": "allergic reactions to carfilzomib",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of allergic reactions to TGR-1202",
                        "criterion": "allergic reactions to TGR-1202",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of allergic reactions to ... carfilzomib",
                        "criterion": "allergic reactions to carfilzomib",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Uncontrolled inter-current illness",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled inter-current illness",
                        "criterion": "inter-current illness",
                        "requirement": {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Uncontrolled inter-current illness",
                        "criterion": "inter-current illness",
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