{
    "info": {
        "nct_id": "NCT01604031",
        "official_title": "Treatment of B-CLL With Autologous IL2 and CD40 Ligand-Expressing Tumor Cells + Lenalidomide",
        "inclusion_criteria": "ELIGIBILITY FOR BLAST COLLECTION (procurement):\n\n* Patients with B-CLL (not in Richter's transformation) with measurable disease.\n* Procurement consent signed and faxed to Research Coordinator\n* HIV negative (can be pending at this time)\n\nELIGIBILITY FOR VACCINE AND LENALIDOMIDE ADMINISTRATION (protocol entry):\n\n* Manipulated B-CLL cells available (at least 6 injections)\n* Patients with B-CLL (not in Richter's transformation) with measurable disease\n* Patients must have a life expectancy of at least 10 weeks.\n* Patients must be less than 75 years old\n* Patients must have ECOG performance status of 0-2.\n* Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study:\n* Absolute neutrophil count (ANC) of greater than or equal to 500/microL\n* Absolute lymphocyte count (ALC) greater than or equal 200/microL,\n* Hemoglobin greater than or equal 8 g/dL\n* Platelet count greater than or equal 50,000/microL.\n* Patients must be willing to practice appropriate birth control methods during the study and for 28 days after their participation in the treatment portion of the study is concluded.\n* Patients must have adequate liver function:\n* Total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times normal\n* Normal prothrombin time\n* Patients must have adequate renal function (creatinine clearance greater than 50 ml/min).\n* Patients provide informed consent.\n* Patient must not have received treatment with other investigational agents within the last 4 weeks.\n* All study participants (treatment) must be registered in the REMS® Program and be willing to comply with the requirements of REMS® .\n\nNote: A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
        "exclusion_criteria": "EXCLUSION CRITERIA FOR VACCINE ADMINISTRATION (protocol entry):\n\n* Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).\n* Pregnant or lactating\n* Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)\n* Receiving immunosuppressive drugs.\n* Received systemic steroids within 30 days of study enrollment\n* Autologous hematopoietic stem cell transplant or fludarabine chemotherapy within 6 months of study enrollment\n* History of allogeneic stem cell transplant\n* Patients with congestive heart failure or significant arrhythmia\n* Known hypersensitivity to thalidomide or lenalidomide.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "ELIGIBILITY FOR BLAST COLLECTION (procurement):",
            "criterions": [
                {
                    "exact_snippets": "ELIGIBILITY FOR BLAST COLLECTION (procurement)",
                    "criterion": "blast collection eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with B-CLL (not in Richter's transformation) with measurable disease.",
            "criterions": [
                {
                    "exact_snippets": "Patients with B-CLL",
                    "criterion": "B-CLL",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not in Richter's transformation",
                    "criterion": "Richter's transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Procurement consent signed and faxed to Research Coordinator",
            "criterions": [
                {
                    "exact_snippets": "Procurement consent signed",
                    "criterion": "procurement consent",
                    "requirements": [
                        {
                            "requirement_type": "signed",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "faxed to Research Coordinator",
                    "criterion": "procurement consent",
                    "requirements": [
                        {
                            "requirement_type": "faxed",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV negative (can be pending at this time)",
            "criterions": [
                {
                    "exact_snippets": "HIV negative",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "ELIGIBILITY FOR VACCINE AND LENALIDOMIDE ADMINISTRATION (protocol entry):",
            "criterions": [
                {
                    "exact_snippets": "ELIGIBILITY FOR VACCINE",
                    "criterion": "vaccine eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ELIGIBILITY FOR ... LENALIDOMIDE ADMINISTRATION",
                    "criterion": "lenalidomide administration eligibility",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Manipulated B-CLL cells available (at least 6 injections)",
            "criterions": [
                {
                    "exact_snippets": "Manipulated B-CLL cells available",
                    "criterion": "manipulated B-CLL cells",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 6 injections",
                    "criterion": "injections",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 6,
                                "unit": "injections"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with B-CLL (not in Richter's transformation) with measurable disease",
            "criterions": [
                {
                    "exact_snippets": "Patients with B-CLL",
                    "criterion": "B-CLL",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not in Richter's transformation",
                    "criterion": "Richter's transformation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "measurable disease",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have a life expectancy of at least 10 weeks.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 10 weeks",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be less than 75 years old",
            "criterions": [
                {
                    "exact_snippets": "less than 75 years old",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<",
                                "value": 75,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have ECOG performance status of 0-2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status of 0-2",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 2,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have recovered from the toxic effects of all prior chemotherapy before entering this study:",
            "criterions": [
                {
                    "exact_snippets": "recovered from the toxic effects of all prior chemotherapy",
                    "criterion": "recovery from prior chemotherapy toxicity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "recovered"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) of greater than or equal to 500/microL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) of greater than or equal to 500/microL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "microL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute lymphocyte count (ALC) greater than or equal 200/microL,",
            "criterions": [
                {
                    "exact_snippets": "Absolute lymphocyte count (ALC) greater than or equal 200/microL",
                    "criterion": "absolute lymphocyte count (ALC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 200,
                                "unit": "microL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin greater than or equal 8 g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin greater than or equal 8 g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count greater than or equal 50,000/microL.",
            "criterions": [
                {
                    "exact_snippets": "Platelet count greater than or equal 50,000/microL.",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 50000,
                                "unit": "microL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be willing to practice appropriate birth control methods during the study and for 28 days after their participation in the treatment portion of the study is concluded.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be willing to practice appropriate birth control methods",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "during the study and for 28 days after their participation in the treatment portion of the study is concluded",
                    "criterion": "duration of birth control",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "during the study and for 28 days after their participation in the treatment portion of the study is concluded"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate liver function:",
            "criterions": [
                {
                    "exact_snippets": "adequate liver function",
                    "criterion": "liver function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total bilirubin less than or equal to 1.5 mg/dl, SGOT less than or equal to 3 times normal",
            "criterions": [
                {
                    "exact_snippets": "Total bilirubin less than or equal to 1.5 mg/dl",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SGOT less than or equal to 3 times normal",
                    "criterion": "SGOT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "times normal"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal prothrombin time",
            "criterions": [
                {
                    "exact_snippets": "Normal prothrombin time",
                    "criterion": "prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequate renal function (creatinine clearance greater than 50 ml/min).",
            "criterions": [
                {
                    "exact_snippets": "adequate renal function (creatinine clearance greater than 50 ml/min)",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "creatinine clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 50,
                                "unit": "ml/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients provide informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Patients provide informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "provision",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must not have received treatment with other investigational agents within the last 4 weeks.",
            "criterions": [
                {
                    "exact_snippets": "Patient must not have received treatment with other investigational agents within the last 4 weeks.",
                    "criterion": "treatment with other investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All study participants (treatment) must be registered in the REMS® Program and be willing to comply with the requirements of REMS® .",
            "criterions": [
                {
                    "exact_snippets": "All study participants (treatment) must be registered in the REMS® Program",
                    "criterion": "REMS® Program registration",
                    "requirements": [
                        {
                            "requirement_type": "registration",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be willing to comply with the requirements of REMS®",
                    "criterion": "willingness to comply with REMS® requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).",
            "criterions": [
                {
                    "exact_snippets": "has not undergone a hysterectomy",
                    "criterion": "hysterectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has not been naturally postmenopausal",
                    "criterion": "natural menopause",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "amenorrhea following cancer therapy does not rule out childbearing potential",
                    "criterion": "amenorrhea following cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "impact on childbearing potential",
                            "expected_value": "does not rule out"
                        }
                    ]
                },
                {
                    "exact_snippets": "for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)",
                    "criterion": "menses",
                    "requirements": [
                        {
                            "requirement_type": "occurrence",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<",
                                        "value": 24,
                                        "unit": "months"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "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"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 75 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 75 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 75,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "EXCLUSION CRITERIA FOR VACCINE ADMINISTRATION (protocol entry):",
            "criterions": [
                {
                    "exact_snippets": "EXCLUSION CRITERIA FOR VACCINE ADMINISTRATION",
                    "criterion": "vaccine administration",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Infected at time of protocol entry, or receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole).",
            "criterions": [
                {
                    "exact_snippets": "Infected at time of protocol entry",
                    "criterion": "infection status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving antibiotics (other than prophylactic trimethoprim sulfamethoxazole)",
                    "criterion": "antibiotic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "prophylactic trimethoprim sulfamethoxazole"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant or lactating",
            "criterions": [
                {
                    "exact_snippets": "Pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "lactating",
                    "criterion": "lactation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Suffering from an autoimmune disease (including refractory immune thrombocytopenia-ITP or refractory autoimmune hemolytic anemia-AIHA)",
            "criterions": [
                {
                    "exact_snippets": "Suffering from an autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory immune thrombocytopenia-ITP",
                    "criterion": "refractory immune thrombocytopenia (ITP)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory autoimmune hemolytic anemia-AIHA",
                    "criterion": "refractory autoimmune hemolytic anemia (AIHA)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Receiving immunosuppressive drugs.",
            "criterions": [
                {
                    "exact_snippets": "Receiving immunosuppressive drugs",
                    "criterion": "immunosuppressive drug use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Received systemic steroids within 30 days of study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Received systemic steroids within 30 days of study enrollment",
                    "criterion": "systemic steroid use",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Autologous hematopoietic stem cell transplant or fludarabine chemotherapy within 6 months of study enrollment",
            "criterions": [
                {
                    "exact_snippets": "Autologous hematopoietic stem cell transplant ... within 6 months of study enrollment",
                    "criterion": "autologous hematopoietic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fludarabine chemotherapy within 6 months of study enrollment",
                    "criterion": "fludarabine chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* History of allogeneic stem cell transplant",
            "criterions": [
                {
                    "exact_snippets": "History of allogeneic stem cell transplant",
                    "criterion": "allogeneic stem cell transplant",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with congestive heart failure or significant arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Patients with congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "significant arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to thalidomide or lenalidomide.",
            "criterions": [
                {
                    "exact_snippets": "Known hypersensitivity to thalidomide",
                    "criterion": "hypersensitivity to thalidomide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Known hypersensitivity to ... lenalidomide",
                    "criterion": "hypersensitivity to lenalidomide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
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