{
    "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 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"
                        ],
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                        "requirement_type": "confirmation",
                        "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",
                        "requirement_type": "quantity",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 2
                                }
                            ]
                        }
                    },
                    {
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                            "DLBCL",
                            "eligible if there is no available standard therapy"
                        ],
                        "criterion": "standard therapy",
                        "requirement_type": "availability",
                        "expected_value": false
                    }
                ]
            },
            "logical_structure": {
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                        {
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                                "histologically confirmed R/R NHL"
                            ],
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                            "requirement_type": "confirmation",
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                        },
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                                "NHL other than diffuse large B cell lymphomas (DLBCL)",
                                "must have received at least 2 prior therapies"
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                        "DLBCL",
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                    ],
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                }
            }
        },
        {
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                "line": "* Must have received front line chemotherapy. No upper limit for the number of prior therapies",
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                    {
                        "exact_snippets": [
                            "Must have received front line chemotherapy"
                        ],
                        "criterion": "front line chemotherapy",
                        "requirement_type": "receipt",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "No upper limit for the number of prior therapies"
                        ],
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                        "requirement_type": "number",
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                    }
                ]
            },
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                    {
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                            "Must have received front line chemotherapy"
                        ],
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                    },
                    {
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                            "No upper limit for the number of prior therapies"
                        ],
                        "criterion": "prior therapies",
                        "requirement_type": "number",
                        "expected_value": "no upper limit"
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Evaluable Disease in the Phase I, and measurable disease in the Phase II",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Evaluable Disease",
                            "Phase I"
                        ],
                        "criterion": "disease",
                        "requirement_type": "evaluability",
                        "expected_value": "evaluable"
                    },
                    {
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                            "measurable disease",
                            "Phase II"
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                        "requirement_type": "measurability",
                        "expected_value": "measurable"
                    }
                ]
            },
            "logical_structure": {
                "xor_criteria": [
                    {
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                                {
                                    "exact_snippets": [
                                        "Evaluable Disease",
                                        "Phase I"
                                    ],
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                                    "requirement_type": "evaluability",
                                    "expected_value": "evaluable"
                                }
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                        "then_criteria": null,
                        "else_criteria": null
                    },
                    {
                        "condition": {
                            "and_criteria": [
                                {
                                    "exact_snippets": [
                                        "measurable disease",
                                        "Phase II"
                                    ],
                                    "criterion": "disease",
                                    "requirement_type": "measurability",
                                    "expected_value": "measurable"
                                }
                            ]
                        },
                        "then_criteria": null,
                        "else_criteria": null
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Age > 18 years",
                "criterions": [
                    {
                        "exact_snippets": [
                            "Age > 18 years"
                        ],
                        "criterion": "age",
                        "requirement_type": "N/A",
                        "expected_value": {
                            "operator": ">",
                            "value": 18
                        }
                    }
                ]
            },
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                            "Age > 18 years"
                        ],
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                            "operator": ">",
                            "value": 18
                        }
                    }
                ]
            }
        },
        {
            "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_type": "severity",
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                                {
                                    "operator": "<",
                                    "value": 2
                                }
                            ]
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                    }
                ]
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                        "exact_snippets": [
                            "Eastern Cooperative Oncology Group (ECOG) performance status < 2"
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                                    "operator": "<",
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                    }
                ]
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        },
        {
            "identified_line": {
                "line": "* Patients must have adequate organ and marrow function",
                "criterions": [
                    {
                        "exact_snippets": [
                            "adequate organ"
                        ],
                        "criterion": "organ function",
                        "requirement_type": "adequacy",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "adequate",
                            "marrow function"
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                        "criterion": "marrow function",
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                    }
                ]
            },
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                            "adequate organ"
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                    },
                    {
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                            "adequate",
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            }
        },
        {
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                "line": "* Adequate Contraception",
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                    {
                        "exact_snippets": [
                            "Adequate Contraception"
                        ],
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                    }
                ]
            },
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                        "exact_snippets": [
                            "Adequate Contraception"
                        ],
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "* Ability to understand and the willingness to sign a written informed consent document",
                "criterions": [
                    {
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                        ],
                        "criterion": "understanding",
                        "requirement_type": "ability",
                        "expected_value": true
                    },
                    {
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                        "requirement_type": "willingness to sign",
                        "expected_value": true
                    }
                ]
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                            "Ability to understand"
                        ],
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                    },
                    {
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                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
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                            "Healthy volunteers allowed"
                        ],
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                    }
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        },
        {
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                    {
                        "exact_snippets": [
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                ]
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    ],
    "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"
                        ],
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                    },
                    {
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                    },
                    {
                        "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",
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                    },
                    {
                        "exact_snippets": [
                            "No other investigational agents are allowed"
                        ],
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                    }
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        },
        {
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                "line": "2. History of allergic reactions to TGR-1202 or carfilzomib",
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                        ],
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                            "carfilzomib"
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        {
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                        "requirement_type": "control status",
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                }
            }
        },
        {
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                "line": "4. Pregnant women",
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                            "Pregnant women"
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                        "criterion": "pregnancy",
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                ]
            },
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                        "Pregnant women"
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                }
            }
        },
        {
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                "line": "5. Nursing women",
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                        "exact_snippets": [
                            "Nursing women"
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                    }
                ]
            },
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        },
        {
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        },
        {
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                "line": "7. Patient known to be Human Immunodeficiency Virus (HIV)-positive",
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                            "Patient known to be Human Immunodeficiency Virus (HIV)-positive"
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        {
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                    {
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                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [
        {
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    ],
    "failed_inclusion": [
        {
            "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.",
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                    {
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                            "histologically confirmed R/R NHL or HL"
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                        "criterion": "R/R NHL or HL",
                        "requirement_type": "confirmation",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "defined by World Health Organization (WHO) criteria"
                        ],
                        "criterion": "R/R NHL or HL",
                        "requirement_type": "definition",
                        "expected_value": "World Health Organization (WHO) criteria"
                    },
                    {
                        "exact_snippets": [
                            "Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible"
                        ],
                        "criterion": "chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)",
                        "requirement_type": "eligibility",
                        "expected_value": true
                    },
                    {
                        "exact_snippets": [
                            "patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least 2 prior therapies"
                        ],
                        "criterion": "NHL other than DLBCL",
                        "requirement_type": "prior therapies",
                        "expected_value": {
                            "comparisons": [
                                {
                                    "operator": ">=",
                                    "value": 2
                                }
                            ]
                        }
                    },
                    {
                        "exact_snippets": [
                            "Patients with DLBCL and HL will be eligible if there is no available standard therapy"
                        ],
                        "criterion": "DLBCL and HL",
                        "requirement_type": "eligibility",
                        "expected_value": "no available standard therapy"
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": [
                                            "histologically confirmed R/R NHL or HL"
                                        ],
                                        "criterion": "R/R NHL or HL",
                                        "requirement_type": "confirmation",
                                        "expected_value": true
                                    },
                                    {
                                        "exact_snippets": [
                                            "defined by World Health Organization (WHO) criteria"
                                        ],
                                        "criterion": "R/R NHL or HL",
                                        "requirement_type": "definition",
                                        "expected_value": "World Health Organization (WHO) criteria"
                                    }
                                ]
                            },
                            {
                                "exact_snippets": [
                                    "Patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are eligible"
                                ],
                                "criterion": "chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL)",
                                "requirement_type": "eligibility",
                                "expected_value": true
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}