{
    "info": {
        "nct_id": "NCT00113048",
        "official_title": "A Phase I Study of Subcutaneously Administered CAMPATH in CD52 Expressing Hematologic Malignancies",
        "inclusion_criteria": "* Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma\n* Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52\n* Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)\n* Patients have recovered from the acute side effects due to prior therapy\n* Life expectancy of > 3 months\n* World Health Organization (WHO) Performance Status 0-2\n* 18 years of age or older\n* Adequate organ function as defined in the protocol\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior therapy with CAMPATH\n* Use of an investigational agent within two (2) weeks prior to study enrollment\n* History of anaphylaxis following exposure to humanized monoclonal antibodies\n* Known human immunodeficiency virus (HIV) positive\n* Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry\n* A history or prior allogenic bone marrow transplant or organ transplant\n* Known, symptomatic central nervous system (CNS) involvement with lymphoma\n* Pregnant or lactating women\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients with relapsed or refractory hematologic malignancy. The anticipated patient population are patients with chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma or myeloma",
            "criterions": [
                {
                    "exact_snippets": "relapsed or refractory hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "relapsed",
                                "refractory"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic lymphocytic leukemia (CLL)",
                    "criterion": "chronic lymphocytic leukemia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-Hodgkin's lymphoma",
                    "criterion": "non-Hodgkin's lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myeloma",
                    "criterion": "myeloma",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of a hematologic malignancy that has previously been shown by flow cytometry or immunophenotyping analysis to express CD52",
            "criterions": [
                {
                    "exact_snippets": "history of a hematologic malignancy",
                    "criterion": "hematologic malignancy",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "shown by flow cytometry or immunophenotyping analysis to express CD52",
                    "criterion": "CD52 expression",
                    "requirements": [
                        {
                            "requirement_type": "method of detection",
                            "expected_value": [
                                "flow cytometry",
                                "immunophenotyping analysis"
                            ]
                        },
                        {
                            "requirement_type": "expression",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any chemotherapy, major surgery or irradiation must have been completed at least four (4) weeks before enrollment in this study (6 weeks for mitomycin-C or nitrosourea)",
            "criterions": [
                {
                    "exact_snippets": "Any chemotherapy ... must have been completed at least four (4) weeks before enrollment",
                    "criterion": "chemotherapy completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "major surgery ... must have been completed at least four (4) weeks before enrollment",
                    "criterion": "major surgery completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "irradiation must have been completed at least four (4) weeks before enrollment",
                    "criterion": "irradiation completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "mitomycin-C ... must have been completed ... 6 weeks",
                    "criterion": "mitomycin-C completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "nitrosourea ... must have been completed ... 6 weeks",
                    "criterion": "nitrosourea completion",
                    "requirements": [
                        {
                            "requirement_type": "time since completion",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients have recovered from the acute side effects due to prior therapy",
            "criterions": [
                {
                    "exact_snippets": "recovered from the acute side effects due to prior therapy",
                    "criterion": "recovery from acute side effects",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Life expectancy of > 3 months",
            "criterions": [
                {
                    "exact_snippets": "Life expectancy of > 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* World Health Organization (WHO) Performance Status 0-2",
            "criterions": [
                {
                    "exact_snippets": "World Health Organization (WHO) Performance Status 0-2",
                    "criterion": "WHO Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* 18 years of age or older",
            "criterions": [
                {
                    "exact_snippets": "18 years of age or older",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function as defined in the protocol",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": "as defined in the protocol"
                        }
                    ]
                }
            ]
        },
        {
            "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": "* Prior therapy with CAMPATH",
            "criterions": [
                {
                    "exact_snippets": "Prior therapy with CAMPATH",
                    "criterion": "CAMPATH therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Use of an investigational agent within two (2) weeks prior to study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Use of an investigational agent within two (2) weeks prior to study enrollment",
                    "criterion": "use of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since last use",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of anaphylaxis following exposure to humanized monoclonal antibodies",
            "criterions": [
                {
                    "exact_snippets": "History of anaphylaxis following exposure to humanized monoclonal antibodies",
                    "criterion": "anaphylaxis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "History of anaphylaxis following exposure to humanized monoclonal antibodies",
                    "criterion": "exposure to humanized monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known human immunodeficiency virus (HIV) positive",
            "criterions": [
                {
                    "exact_snippets": "Known human immunodeficiency virus (HIV) positive",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "positive"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior autologous bone marrow or stem cell transplant if within six (6) months of study entry",
            "criterions": [
                {
                    "exact_snippets": "Prior autologous bone marrow or stem cell transplant",
                    "criterion": "autologous bone marrow or stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* A history or prior allogenic bone marrow transplant or organ transplant",
            "criterions": [
                {
                    "exact_snippets": "A history or prior allogenic bone marrow transplant",
                    "criterion": "allogenic bone marrow transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "A history or prior ... organ transplant",
                    "criterion": "organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known, symptomatic central nervous system (CNS) involvement with lymphoma",
            "criterions": [
                {
                    "exact_snippets": "Known, symptomatic central nervous system (CNS) involvement with lymphoma",
                    "criterion": "central nervous system (CNS) involvement with lymphoma",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "known",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating women",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating women",
                    "criterion": "lactation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection)",
                    "criterion": "uncontrolled intercurrent illness",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection (excluding skin infection, lower urinary tract infection, or oral infection)",
                    "criterion": "ongoing or active infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "symptomatic congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "unstable angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance with study requirements",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}