{
    "info": {
        "nct_id": "NCT01775631",
        "official_title": "A Phase 1b, Open-label, Multicenter Study of Urelumab (BMS-663513) in Combination With Rituximab in Subjects With Relapsed/Refractory B-cell Malignancies",
        "inclusion_criteria": "* Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)\n* Progressed or refractory to at least 1 prior line of standard therapy\n* Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens\n* Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment\n* Eastern Cooperative Oncology Group (ECOG) of 0 to 1\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Active or progressing brain metastases\n* Other concomitant malignancies (with some exceptions per protocol)\n* Active or history of autoimmune disease\n* Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune deficiency syndrome (AIDS)\n* History of any hepatitis (A, B or C)\n* History of grade 3-4 drug-related hepatitis\n* Known current drug or alcohol abuse\n* Active tuberculosis (TB)\n* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy",
        "miscellaneous_criteria": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com."
    },
    "inclusion_lines": [
        {
            "line": "* Clinical diagnosis of relapsed/refractory B-cell Malignancies (B-Non-Hodgkins Lymphoma (NHL)) per International Workshop Group (IWG)",
            "criterions": [
                {
                    "exact_snippets": "Clinical diagnosis of relapsed/refractory B-cell Malignancies",
                    "criterion": "B-cell Malignancies",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "relapsed/refractory"
                        }
                    ]
                },
                {
                    "exact_snippets": "B-Non-Hodgkins Lymphoma (NHL)",
                    "criterion": "B-Non-Hodgkins Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "per International Workshop Group (IWG)",
                    "criterion": "diagnosis criteria",
                    "requirements": [
                        {
                            "requirement_type": "standard",
                            "expected_value": "International Workshop Group (IWG)"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progressed or refractory to at least 1 prior line of standard therapy",
            "criterions": [
                {
                    "exact_snippets": "Progressed or refractory to at least 1 prior line of standard therapy",
                    "criterion": "response to prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "progressed",
                                "refractory"
                            ]
                        },
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line of standard therapy"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens",
            "criterions": [
                {
                    "exact_snippets": "relapsed/refractory diffuse large B-cell lymphoma (DLBCL)",
                    "criterion": "diffuse large B-cell lymphoma (DLBCL)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Follicular Lymphoma (FL) subjects who are either relapsed or refractory",
                    "criterion": "Follicular Lymphoma (FL)",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens",
                    "criterion": "rituximab or ritxumab-containing chemotherapy regimens",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Follicular Lymphoma (FL) must have at least 1 lesion that can be biopsied at screening and on treatment",
            "criterions": [
                {
                    "exact_snippets": "Follicular Lymphoma (FL)",
                    "criterion": "Follicular Lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 1 lesion that can be biopsied",
                    "criterion": "biopsiable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) of 0 to 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Active or progressing brain metastases",
            "criterions": [
                {
                    "exact_snippets": "Active or progressing brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "progressing"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Other concomitant malignancies (with some exceptions per protocol)",
            "criterions": [
                {
                    "exact_snippets": "Other concomitant malignancies",
                    "criterion": "concomitant malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active or history of autoimmune disease",
            "criterions": [
                {
                    "exact_snippets": "Active or history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Positive test for human immunodeficiency virus (HIV) 1&2 or known Acquired immune deficiency syndrome (AIDS)",
            "criterions": [
                {
                    "exact_snippets": "Positive test for human immunodeficiency virus (HIV) 1&2",
                    "criterion": "HIV 1&2",
                    "requirements": [
                        {
                            "requirement_type": "test result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "known Acquired immune deficiency syndrome (AIDS)",
                    "criterion": "Acquired immune deficiency syndrome (AIDS)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of any hepatitis (A, B or C)",
            "criterions": [
                {
                    "exact_snippets": "History of any hepatitis (A, B or C)",
                    "criterion": "hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": [
                                "A",
                                "B",
                                "C"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of grade 3-4 drug-related hepatitis",
            "criterions": [
                {
                    "exact_snippets": "History of grade 3-4 drug-related hepatitis",
                    "criterion": "drug-related hepatitis",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "grade 3-4"
                        },
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known current drug or alcohol abuse",
            "criterions": [
                {
                    "exact_snippets": "Known current drug or alcohol abuse",
                    "criterion": "drug abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known current drug or alcohol abuse",
                    "criterion": "alcohol abuse",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Active tuberculosis (TB)",
            "criterions": [
                {
                    "exact_snippets": "Active tuberculosis (TB)",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR). However, Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with any antibody/drug that targets the T cell coregulatory proteins, including but not limited to, anti-CD137, Anti Cytotoxic T lymphocyte-associated antigen 4 (anti-CTLA4) or Anti-Glucocorticoid-induced tumor necrosis factor receptor (anti-GITR)",
                    "criterion": "prior therapy with T cell coregulatory protein-targeting antibodies/drugs",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Anti-Programmed Death-1 (anti-PD-1), Anti-Programmed Death-Ligand1 (anti-PD-L1) are permissible as prior therapy",
                    "criterion": "prior therapy with anti-PD-1 or anti-PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.",
            "criterions": []
        }
    ]
}