{
"info": {
"nct_id": "NCT02975882",
"official_title": "A Phase 1 Study of ABI-009 (NAB-RAPAMYCIN) in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors as a Single Agent and in Combination With Temozolomide and Irinotecan",
"inclusion_criteria": "* Patients must have a body surface area (BSA) of >= 0.2 m^2 at the time of study enrollment\n* Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)\n* Patients must have either measurable or evaluable disease\n* Patient's current disease state must be one for which there is no known curative therapy\n* Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age\n\n * Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately\n* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n\n * >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)\n* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment\n* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1\n* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\n* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator\n* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)\n* Stem cell infusions (with or without total body irradiation [TBI]):\n\n * Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion, and no evidence of graft-versus-host disease (GVHD)\n * Autologous stem cell infusion including boost infusion: >= 42 days\n* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)\n* X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation\n* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy\n* Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:\n\n * Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible\n * Patients who have received prior therapy with ABI-009 are not eligible\n * Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible\n * Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible\n * Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible\n* Adequate Bone Marrow Function Defined as:\n* For patients with solid tumors without known bone marrow involvement (no older than 7 days at the start of therapy):\n\n * Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\n * Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\n * Hemoglobin >= 8.0 g/dl at baseline (may receive red blood cell [RBC] transfusions)\n* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows (no older than 7 days at the start of therapy):\n\n * Age: maximum serum creatinine (mg/dL)\n * 1 to < 2 years: 0.6 (male and female)\n * 2 to < 6 years: 0.8 (male and female)\n * 6 to < 10 years: 1 (male and female)\n * 10 to < 13 years: 1.2 (male and female)\n * 13 to < 16 years: 1.5 (male), 1.4 (female)\n * >= 16 years: 1.7 (male), 1.4 (female)\n* Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (no older than 7 days at the start of therapy)\n* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L (no older than 7 days at the start of therapy)\n* Serum albumin >= 2 g/dL (no older than 7 days at the start of therapy)\n* Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)\n* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled\n* Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) resulting from prior therapy must be =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible\n* Serum triglyceride level =< 300 mg/dL (no older than 7 days at the start of therapy)\n* Serum total cholesterol level =< 300 mg/dL (no older than 7 days at the start of therapy)\n* Random or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age (no older than 7 days at the start of therapy)\n* International normalized ratio (INR) =< 1.5 (no older than 7 days at the start of therapy)\n* Not currently receiving anticoagulation therapy\n* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines\n* Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment\nHealthy volunteers allowed\nMust have minimum age of 12 Months\nMust have maximum age of 21 Years",
"exclusion_criteria": "* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 6 months after participation in this study; abstinence is an acceptable method of contraception\n* Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid\n* Patients who are currently receiving another investigational drug are not eligible\n* Patients who are currently receiving other anti-cancer agents are not eligible\n* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial\n* Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment\n* Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible\n* Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible\n* Patients with interstitial lung disease and/or pneumonitis are not eligible\n* Patients with a history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics, temsirolimus/other mTOR inhibitors, temozolomide or irinotecan are not eligible\n* Patients with hypersensitivity to albumin are not eligible\n* Patients who have had or are planning to have the following invasive procedures are not eligible:\n\n * Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment\n * Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment\n * Core biopsy within 7 days prior to enrollment\n * Fine needle aspirate within 7 days prior to enrollment\n * NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy\n* Patients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible\n* Patients with a history of, or current grade 4 depression are not eligible\n* Patients who have an uncontrolled infection are not eligible\n* Patients who have received a prior solid organ transplantation are not eligible\n* Patients who have known bone marrow involvement are not eligible\n* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Patients must have a body surface area (BSA) of >= 0.2 m^2 at the time of study enrollment",
"criterions": [
{
"exact_snippets": "body surface area (BSA) of >= 0.2 m^2",
"criterion": "body surface area",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 0.2,
"unit": "m^2"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "body surface area (BSA) of >= 0.2 m^2",
"criterion": "body surface area",
"requirement": {
"requirement_type": "size",
"expected_value": {
"operator": ">=",
"value": 0.2,
"unit": "m^2"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with recurrent or refractory solid tumors, including CNS tumors, are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse except in patients with intrinsic brain stem tumors, optic pathway gliomas, or patients with pineal tumors and elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)",
"criterions": [
{
"exact_snippets": "recurrent or refractory solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "recurrent or refractory solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "refractory",
"expected_value": true
}
},
{
"exact_snippets": "CNS tumors",
"criterion": "CNS tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "histologic verification of malignancy",
"criterion": "malignancy",
"requirement": {
"requirement_type": "verification",
"expected_value": "histologic"
}
},
{
"exact_snippets": "intrinsic brain stem tumors",
"criterion": "intrinsic brain stem tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "optic pathway gliomas",
"criterion": "optic pathway gliomas",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pineal tumors",
"criterion": "pineal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)",
"criterion": "tumor markers",
"requirement": {
"requirement_type": "elevation",
"expected_value": true
}
},
{
"exact_snippets": "elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)",
"criterion": "tumor markers",
"requirement": {
"requirement_type": "types",
"expected_value": [
"alpha-fetoprotein",
"beta-human chorionic gonadotropin (HCG)"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "recurrent or refractory solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "recurrence",
"expected_value": true
}
},
{
"exact_snippets": "recurrent or refractory solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "refractory",
"expected_value": true
}
}
]
},
{
"or_criteria": [
{
"exact_snippets": "CNS tumors",
"criterion": "CNS tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "intrinsic brain stem tumors",
"criterion": "intrinsic brain stem tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "optic pathway gliomas",
"criterion": "optic pathway gliomas",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"and_criteria": [
{
"exact_snippets": "pineal tumors",
"criterion": "pineal tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)",
"criterion": "tumor markers",
"requirement": {
"requirement_type": "elevation",
"expected_value": true
}
},
{
"exact_snippets": "elevations of cerebrospinal fluid (CSF) or serum tumor markers including alpha-fetoprotein or beta-human chorionic gonadotropin (HCG)",
"criterion": "tumor markers",
"requirement": {
"requirement_type": "types",
"expected_value": [
"alpha-fetoprotein",
"beta-human chorionic gonadotropin (HCG)"
]
}
}
]
}
]
}
]
},
{
"exact_snippets": "histologic verification of malignancy",
"criterion": "malignancy",
"requirement": {
"requirement_type": "verification",
"expected_value": "histologic"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patient's current disease state must be one for which there is no known curative therapy",
"criterions": [
{
"exact_snippets": "Patient's current disease state ... no known curative therapy",
"criterion": "current disease state",
"requirement": {
"requirement_type": "curative therapy availability",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patient's current disease state ... no known curative therapy",
"criterion": "current disease state",
"requirement": {
"requirement_type": "curative therapy availability",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16 years of age",
"criterions": [
{
"exact_snippets": "Karnofsky >= 50% for patients > 16 years of age",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
{
"exact_snippets": "Karnofsky >= 50% for patients > 16 years of age",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 16,
"unit": "years"
}
}
},
{
"exact_snippets": "Lansky >= 50 for patients =< 16 years of age",
"criterion": "Lansky performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "N/A"
}
}
},
{
"exact_snippets": "Lansky >= 50 for patients =< 16 years of age",
"criterion": "Lansky performance status",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 16,
"unit": "years"
}
}
}
]
},
"logical_structure": {
"xor_criteria": [
{
"condition": {
"exact_snippets": "Karnofsky >= 50% for patients > 16 years of age",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": ">",
"value": 16,
"unit": "years"
}
}
},
"then_criteria": {
"exact_snippets": "Karnofsky >= 50% for patients > 16 years of age",
"criterion": "Karnofsky performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "%"
}
}
},
"else_criteria": null
},
{
"condition": {
"exact_snippets": "Lansky >= 50 for patients =< 16 years of age",
"criterion": "Lansky performance status",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 16,
"unit": "years"
}
}
},
"then_criteria": {
"exact_snippets": "Lansky >= 50 for patients =< 16 years of age",
"criterion": "Lansky performance status",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 50,
"unit": "N/A"
}
}
},
"else_criteria": null
}
]
}
},
{
"identified_line": {
"line": "* Note: Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment; patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score",
"criterions": [
{
"exact_snippets": "Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment",
"criterion": "neurologic deficits",
"requirement": {
"requirement_type": "stability",
"expected_value": "relatively stable for at least 7 days prior to study enrollment"
}
},
{
"exact_snippets": "patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory",
"criterion": "ambulatory status",
"requirement": {
"requirement_type": "condition",
"expected_value": "patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Neurologic deficits in patients with CNS tumors must have been relatively stable for at least 7 days prior to study enrollment",
"criterion": "neurologic deficits",
"requirement": {
"requirement_type": "stability",
"expected_value": "relatively stable for at least 7 days prior to study enrollment"
}
},
{
"exact_snippets": "patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory",
"criterion": "ambulatory status",
"requirement": {
"requirement_type": "condition",
"expected_value": "patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately",
"criterions": [
{
"exact_snippets": "fully recovered from the acute toxic effects of all prior anti-cancer therapy",
"criterion": "recovery from acute toxic effects",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
},
{
"exact_snippets": "minimum duration from prior anti-cancer directed therapy",
"criterion": "duration from prior anti-cancer therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": "minimum duration"
}
},
{
"exact_snippets": "numerical eligibility criteria ... blood count criteria",
"criterion": "blood count",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "numerical criteria met"
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "fully recovered from the acute toxic effects of all prior anti-cancer therapy",
"criterion": "recovery from acute toxic effects",
"requirement": {
"requirement_type": "recovery",
"expected_value": true
}
},
{
"exact_snippets": "minimum duration from prior anti-cancer directed therapy",
"criterion": "duration from prior anti-cancer therapy",
"requirement": {
"requirement_type": "duration",
"expected_value": "minimum duration"
}
}
]
},
{
"exact_snippets": "numerical eligibility criteria ... blood count criteria",
"criterion": "blood count",
"requirement": {
"requirement_type": "eligibility",
"expected_value": "numerical criteria met"
}
}
]
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment",
"criterions": [
{
"exact_snippets": "Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive",
"criterion": "use of myelosuppressive agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive",
"criterion": "use of myelosuppressive agents",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"and_criteria": [
{
"exact_snippets": "the duration of this interval must be discussed with the study chair",
"criterion": "discussion with study chair",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
},
{
"exact_snippets": "the duration of this interval must be discussed with the ... study-assigned research coordinator prior to enrollment",
"criterion": "discussion with study-assigned research coordinator",
"requirement": {
"requirement_type": "completion",
"expected_value": true
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea)",
"criterions": [
{
"exact_snippets": "... >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy ...",
"criterion": "time since last dose of cytotoxic or myelosuppressive chemotherapy",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
},
{
"exact_snippets": "... (42 days if prior nitrosourea)",
"criterion": "time since last dose of nitrosourea",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "... (42 days if prior nitrosourea)",
"criterion": "time since last dose of nitrosourea",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
},
"then_criteria": null,
"else_criteria": {
"exact_snippets": "... >= 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy ...",
"criterion": "time since last dose of cytotoxic or myelosuppressive chemotherapy",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment",
"criterions": [
{
"exact_snippets": "Anti-cancer agents not known to be myelosuppressive",
"criterion": "anti-cancer agents",
"requirement": {
"requirement_type": "myelosuppressive property",
"expected_value": false
}
},
{
"exact_snippets": ">= 7 days after the last dose of agent",
"criterion": "time since last dose of agent",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Anti-cancer agents not known to be myelosuppressive",
"criterion": "anti-cancer agents",
"requirement": {
"requirement_type": "myelosuppressive property",
"expected_value": false
}
},
{
"exact_snippets": ">= 7 days after the last dose of agent",
"criterion": "time since last dose of agent",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
},
{
"exact_snippets": "the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment",
"criterion": "discussion with study chair and research coordinator",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade =< 1",
"criterions": [
{
"exact_snippets": "Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody",
"criterion": "time since last antibody dose",
"requirement": {
"requirement_type": "elapsed time",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
},
{
"exact_snippets": "toxicity related to prior antibody therapy must be recovered to grade =< 1",
"criterion": "toxicity from prior antibody therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Antibodies: >= 21 days must have elapsed from infusion of last dose of antibody",
"criterion": "time since last antibody dose",
"requirement": {
"requirement_type": "elapsed time",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
},
{
"exact_snippets": "toxicity related to prior antibody therapy must be recovered to grade =< 1",
"criterion": "toxicity from prior antibody therapy",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "grade"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid",
"criterions": [
{
"exact_snippets": "Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid",
"criterion": "corticosteroid use",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Corticosteroids: If used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid",
"criterion": "corticosteroid use",
"requirement": {
"requirement_type": "time since last dose",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
"then_criteria": null,
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g. pegfilgrastim) or 7 days for short-acting growth factor; for agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator",
"criterions": [
{
"exact_snippets": "Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor",
"criterion": "time since last dose of long-acting hematopoietic growth factor",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
{
"exact_snippets": "7 days for short-acting growth factor",
"criterion": "time since last dose of short-acting hematopoietic growth factor",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur",
"criterion": "time since last dose of agents with known adverse events beyond 7 days",
"requirement": {
"requirement_type": "duration",
"expected_value": "extended beyond the time during which adverse events are known to occur"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor",
"criterion": "time since last dose of long-acting hematopoietic growth factor",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "7 days for short-acting growth factor",
"criterion": "time since last dose of short-acting hematopoietic growth factor",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur",
"criterion": "time since last dose of agents with known adverse events beyond 7 days",
"requirement": {
"requirement_type": "duration",
"expected_value": "extended beyond the time during which adverse events are known to occur"
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)",
"criterions": [
{
"exact_snippets": "Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)",
"criterion": "interleukins, interferons and cytokines (other than hematopoietic growth factors)",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)",
"criterion": "interleukins, interferons and cytokines (other than hematopoietic growth factors)",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 21,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Stem cell infusions (with or without total body irradiation [TBI]):",
"criterions": [
{
"exact_snippets": "Stem cell infusions (with or without total body irradiation [TBI])",
"criterion": "stem cell infusions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "total body irradiation [TBI]",
"criterion": "total body irradiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "Stem cell infusions (with or without total body irradiation [TBI])",
"criterion": "stem cell infusions",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "total body irradiation [TBI]",
"criterion": "total body irradiation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion, and no evidence of graft-versus-host disease (GVHD)",
"criterions": [
{
"exact_snippets": "Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion",
"criterion": "time since stem cell infusion",
"requirement": {
"requirement_type": "time since infusion",
"expected_value": {
"operator": ">=",
"value": 84,
"unit": "days"
}
}
},
{
"exact_snippets": "no evidence of graft-versus-host disease (GVHD)",
"criterion": "graft-versus-host disease (GVHD)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion",
"criterion": "time since stem cell infusion",
"requirement": {
"requirement_type": "time since infusion",
"expected_value": {
"operator": ">=",
"value": 84,
"unit": "days"
}
}
},
{
"exact_snippets": "Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: >= 84 days after infusion",
"criterion": "time since stem cell infusion",
"requirement": {
"requirement_type": "time since infusion",
"expected_value": {
"operator": ">=",
"value": 84,
"unit": "days"
}
}
}
]
},
{
"exact_snippets": "no evidence of graft-versus-host disease (GVHD)",
"criterion": "graft-versus-host disease (GVHD)",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Autologous stem cell infusion including boost infusion: >= 42 days",
"criterions": [
{
"exact_snippets": "Autologous stem cell infusion including boost infusion: >= 42 days",
"criterion": "autologous stem cell infusion",
"requirement": {
"requirement_type": "time since infusion",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Autologous stem cell infusion including boost infusion: >= 42 days",
"criterion": "autologous stem cell infusion",
"requirement": {
"requirement_type": "time since infusion",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Cellular therapy: >= 42 days after the completion of any type of cellular therapy (e.g. modified T cells, natural killer [NK] cells, dendritic cells, etc.)",
"criterions": [
{
"exact_snippets": "Cellular therapy: >= 42 days after the completion of any type of cellular therapy",
"criterion": "cellular therapy completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Cellular therapy: >= 42 days after the completion of any type of cellular therapy",
"criterion": "cellular therapy completion",
"requirement": {
"requirement_type": "time since completion",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT; >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis; >= 42 days if other substantial bone marrow (BM) radiation",
"criterions": [
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT",
"criterion": "time since local XRT",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: ... >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis",
"criterion": "time since TBI, craniospinal XRT, or radiation to >= 50% of the pelvis",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 150,
"unit": "days"
}
}
},
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: ... >= 42 days if other substantial bone marrow (BM) radiation",
"criterion": "time since other substantial BM radiation",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: >= 14 days after local XRT",
"criterion": "time since local XRT",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
},
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: ... >= 150 days after TBI, craniospinal XRT or if radiation to >= 50% of the pelvis",
"criterion": "time since TBI, craniospinal XRT, or radiation to >= 50% of the pelvis",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 150,
"unit": "days"
}
}
}
]
},
{
"exact_snippets": "X ray (XRT)/external beam irradiation including protons: ... >= 42 days if other substantial bone marrow (BM) radiation",
"criterion": "time since other substantial BM radiation",
"requirement": {
"requirement_type": "time since treatment",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Radiopharmaceutical therapy (e.g., radiolabeled antibody, 131 iodine metaiodobenzylguanidine [131I-MIBG]): >= 42 days after systemically administered radiopharmaceutical therapy",
"criterions": [
{
"exact_snippets": "Radiopharmaceutical therapy ... >= 42 days after systemically administered radiopharmaceutical therapy",
"criterion": "radiopharmaceutical therapy",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Radiopharmaceutical therapy ... >= 42 days after systemically administered radiopharmaceutical therapy",
"criterion": "radiopharmaceutical therapy",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"operator": ">=",
"value": 42,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure:",
"criterions": [
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "irinotecan exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
},
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "temozolomide exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
},
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "mammalian target of rapamycin (mTOR) inhibitor exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "irinotecan exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
},
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "temozolomide exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
},
{
"exact_snippets": "Irinotecan, temozolomide and mammalian target of rapamycin (mTOR) inhibitor exposure",
"criterion": "mammalian target of rapamycin (mTOR) inhibitor exposure",
"requirement": {
"requirement_type": "exposure",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have received prior single agent therapy with irinotecan, temozolomide, or an mTOR inhibitor, excluding ABI-009, are eligible",
"criterions": [
{
"exact_snippets": "Patients who have received prior single agent therapy with irinotecan",
"criterion": "prior therapy with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have received prior single agent therapy with ... temozolomide",
"criterion": "prior therapy with temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Patients who have received prior single agent therapy with ... an mTOR inhibitor",
"criterion": "prior therapy with an mTOR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "excluding ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Patients who have received prior single agent therapy with irinotecan",
"criterion": "prior therapy with irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "excluding ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients who have received prior single agent therapy with ... temozolomide",
"criterion": "prior therapy with temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "excluding ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Patients who have received prior single agent therapy with ... an mTOR inhibitor",
"criterion": "prior therapy with an mTOR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "excluding ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients who have received prior therapy with ABI-009 are not eligible",
"criterions": [
{
"exact_snippets": "Patients who have received prior therapy with ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have received prior therapy with ABI-009",
"criterion": "prior therapy with ABI-009",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have previously received irinotecan and temozolomide in combination without progressive disease while on therapy are eligible",
"criterions": [
{
"exact_snippets": "Patients who have previously received irinotecan and temozolomide in combination",
"criterion": "irinotecan and temozolomide combination therapy",
"requirement": {
"requirement_type": "history of treatment",
"expected_value": true
}
},
{
"exact_snippets": "without progressive disease while on therapy",
"criterion": "progressive disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have previously received irinotecan and temozolomide in combination",
"criterion": "irinotecan and temozolomide combination therapy",
"requirement": {
"requirement_type": "history of treatment",
"expected_value": true
}
},
{
"exact_snippets": "without progressive disease while on therapy",
"criterion": "progressive disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have previously received irinotecan and temozolomide in combination and had significant toxicity with these two drugs are not eligible",
"criterions": [
{
"exact_snippets": "Patients who have previously received irinotecan and temozolomide in combination",
"criterion": "previous treatment with irinotecan and temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "had significant toxicity with these two drugs",
"criterion": "significant toxicity with irinotecan and temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have previously received irinotecan and temozolomide in combination",
"criterion": "previous treatment with irinotecan and temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "had significant toxicity with these two drugs",
"criterion": "significant toxicity with irinotecan and temozolomide",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor) are not eligible",
"criterions": [
{
"exact_snippets": "Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor)",
"criterion": "prior therapy with irinotecan, temozolomide, and an mTOR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients who have received prior therapy with all three agents in combination (i.e. irinotecan, temozolomide, and an mTOR inhibitor)",
"criterion": "prior therapy with irinotecan, temozolomide, and an mTOR inhibitor",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Adequate Bone Marrow Function Defined as:",
"criterions": [
{
"exact_snippets": "Adequate Bone Marrow Function",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Adequate Bone Marrow Function",
"criterion": "bone marrow function",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* For patients with solid tumors without known bone marrow involvement (no older than 7 days at the start of therapy):",
"criterions": [
{
"exact_snippets": "solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "without known bone marrow involvement",
"criterion": "bone marrow involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "test results age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"condition": {
"and_criteria": [
{
"exact_snippets": "solid tumors",
"criterion": "solid tumors",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "without known bone marrow involvement",
"criterion": "bone marrow involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"then_criteria": {
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "test results age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3",
"criterions": [
{
"exact_snippets": "Peripheral absolute neutrophil count (ANC) >= 1000/mm^3",
"criterion": "peripheral absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "mm^3"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Peripheral absolute neutrophil count (ANC) >= 1000/mm^3",
"criterion": "peripheral absolute neutrophil count (ANC)",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 1000,
"unit": "mm^3"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)",
"criterions": [
{
"exact_snippets": "Platelet count >= 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment",
"criterion": "platelet transfusion",
"requirement": {
"requirement_type": "independence",
"expected_value": true
}
},
{
"exact_snippets": "transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment",
"criterion": "platelet transfusion",
"requirement": {
"requirement_type": "time since last transfusion",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Platelet count >= 100,000/mm^3",
"criterion": "platelet count",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 100000,
"unit": "mm^3"
}
}
},
{
"exact_snippets": "transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment",
"criterion": "platelet transfusion",
"requirement": {
"requirement_type": "independence",
"expected_value": true
}
}
]
},
{
"exact_snippets": "transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment",
"criterion": "platelet transfusion",
"requirement": {
"requirement_type": "time since last transfusion",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Hemoglobin >= 8.0 g/dl at baseline (may receive red blood cell [RBC] transfusions)",
"criterions": [
{
"exact_snippets": "Hemoglobin >= 8.0 g/dl at baseline",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 8.0,
"unit": "g/dl"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Hemoglobin >= 8.0 g/dl at baseline",
"criterion": "hemoglobin level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">=",
"value": 8.0,
"unit": "g/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2 or a serum creatinine based on age/gender as follows (no older than 7 days at the start of therapy):",
"criterions": [
{
"exact_snippets": "Creatinine clearance ... >= 70 ml/min/1.73 m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "ml/min/1.73 m^2"
}
}
},
{
"exact_snippets": "radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2",
"criterion": "radioisotope glomerular filtration rate (GFR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "ml/min/1.73 m^2"
}
}
},
{
"exact_snippets": "serum creatinine based on age/gender",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "value",
"expected_value": "based on age/gender"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Creatinine clearance ... >= 70 ml/min/1.73 m^2",
"criterion": "creatinine clearance",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "ml/min/1.73 m^2"
}
}
},
{
"exact_snippets": "radioisotope glomerular filtration rate (GFR) >= 70 ml/min/1.73 m^2",
"criterion": "radioisotope glomerular filtration rate (GFR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">=",
"value": 70,
"unit": "ml/min/1.73 m^2"
}
}
}
]
},
{
"exact_snippets": "serum creatinine based on age/gender",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "value",
"expected_value": "based on age/gender"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Age: maximum serum creatinine (mg/dL)",
"criterions": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "maximum serum creatinine (mg/dL)"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": "maximum serum creatinine (mg/dL)"
}
}
]
}
},
{
"identified_line": {
"line": "* 1 to < 2 years: 0.6 (male and female)",
"criterions": [
{
"exact_snippets": "1 to < 2 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<",
"value": 2,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "1 to < 2 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1,
"unit": "years"
},
{
"operator": "<",
"value": 2,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* 2 to < 6 years: 0.8 (male and female)",
"criterions": [
{
"exact_snippets": "2 to < 6 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "years"
},
{
"operator": "<",
"value": 6,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "2 to < 6 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 2,
"unit": "years"
},
{
"operator": "<",
"value": 6,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* 6 to < 10 years: 1 (male and female)",
"criterions": [
{
"exact_snippets": "6 to < 10 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "years"
},
{
"operator": "<",
"value": 10,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "6 to < 10 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 6,
"unit": "years"
},
{
"operator": "<",
"value": 10,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "male and female",
"criterion": "gender",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"male",
"female"
]
}
}
]
}
},
{
"identified_line": {
"line": "* 10 to < 13 years: 1.2 (male and female)",
"criterions": [
{
"exact_snippets": "10 to < 13 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 10,
"unit": "years"
},
{
"operator": "<",
"value": 13,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "10 to < 13 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 10,
"unit": "years"
},
{
"operator": "<",
"value": 13,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* 13 to < 16 years: 1.5 (male), 1.4 (female)",
"criterions": [
{
"exact_snippets": "13 to < 16 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 13,
"unit": "years"
},
{
"operator": "<",
"value": 16,
"unit": "years"
}
]
}
}
},
{
"exact_snippets": "1.5 (male)",
"criterion": "value for males",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "1.4 (female)",
"criterion": "value for females",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 1.4,
"unit": "N/A"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "13 to < 16 years",
"criterion": "age",
"requirement": {
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 13,
"unit": "years"
},
{
"operator": "<",
"value": 16,
"unit": "years"
}
]
}
}
},
{
"or_criteria": [
{
"exact_snippets": "1.5 (male)",
"criterion": "value for males",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "1.4 (female)",
"criterion": "value for females",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "=",
"value": 1.4,
"unit": "N/A"
}
}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* >= 16 years: 1.7 (male), 1.4 (female)",
"criterions": [
{
"exact_snippets": "...>= 16 years: 1.7 (male)...",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "years"
}
}
},
{
"exact_snippets": "...1.7 (male)...",
"criterion": "value for males",
"requirement": {
"requirement_type": "value",
"expected_value": ">= 1.7"
}
},
{
"exact_snippets": "...1.4 (female)...",
"criterion": "value for females",
"requirement": {
"requirement_type": "value",
"expected_value": ">= 1.4"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "...>= 16 years: 1.7 (male)...",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "years"
}
}
},
{
"exact_snippets": "...1.7 (male)...",
"criterion": "value for males",
"requirement": {
"requirement_type": "value",
"expected_value": ">= 1.7"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "...>= 16 years: 1.7 (male)...",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 16,
"unit": "years"
}
}
},
{
"exact_snippets": "...1.4 (female)...",
"criterion": "value for females",
"requirement": {
"requirement_type": "value",
"expected_value": ">= 1.4"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age (no older than 7 days at the start of therapy)",
"criterions": [
{
"exact_snippets": "Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN for age"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "age",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for age",
"criterion": "bilirubin level",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "x ULN for age"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "age",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L (no older than 7 days at the start of therapy)",
"criterions": [
{
"exact_snippets": "Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L",
"criterion": "serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 135,
"unit": "U/L"
}
}
},
{
"exact_snippets": "(no older than 7 days at the start of therapy)",
"criterion": "SGPT test result age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 3 x ULN = 135 U/L; for the purpose of this study, the ULN for SGPT is 45 U/L",
"criterion": "serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT])",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 135,
"unit": "U/L"
}
}
},
{
"exact_snippets": "(no older than 7 days at the start of therapy)",
"criterion": "SGPT test result age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Serum albumin >= 2 g/dL (no older than 7 days at the start of therapy)",
"criterions": [
{
"exact_snippets": "Serum albumin >= 2 g/dL",
"criterion": "serum albumin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "g/dL"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Serum albumin >= 2 g/dL",
"criterion": "serum albumin",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": ">=",
"value": 2,
"unit": "g/dL"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "serum albumin test date",
"requirement": {
"requirement_type": "recency",
"expected_value": "no older than 7 days at the start of therapy"
}
}
]
}
},
{
"identified_line": {
"line": "* Pulse oximetry > 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest)",
"criterions": [
{
"exact_snippets": "Pulse oximetry > 94%",
"criterion": "pulse oximetry",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 94,
"unit": "%"
}
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "clinical indication for determination (e.g. dyspnea at rest)",
"criterion": "clinical indication for pulse oximetry",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"exact_snippets": "Pulse oximetry > 94%",
"criterion": "pulse oximetry",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": ">",
"value": 94,
"unit": "%"
}
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Patients with seizure disorder may be enrolled if on non-enzyme inducing anticonvulsants and well controlled",
"criterions": [
{
"exact_snippets": "Patients with seizure disorder",
"criterion": "seizure disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "if on non-enzyme inducing anticonvulsants",
"criterion": "anticonvulsant medication",
"requirement": {
"requirement_type": "type",
"expected_value": "non-enzyme inducing"
}
},
{
"exact_snippets": "well controlled",
"criterion": "seizure control",
"requirement": {
"requirement_type": "status",
"expected_value": "well controlled"
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "Patients with seizure disorder",
"criterion": "seizure disorder",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "if on non-enzyme inducing anticonvulsants",
"criterion": "anticonvulsant medication",
"requirement": {
"requirement_type": "type",
"expected_value": "non-enzyme inducing"
}
},
{
"exact_snippets": "well controlled",
"criterion": "seizure control",
"requirement": {
"requirement_type": "status",
"expected_value": "well controlled"
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "* Nervous system disorders (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) resulting from prior therapy must be =< grade 2 with the exception of decreased tendon reflex (DTR); any grade of DTR is eligible",
"criterions": [
{
"exact_snippets": "Nervous system disorders ... resulting from prior therapy must be =< grade 2",
"criterion": "nervous system disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "decreased tendon reflex (DTR); any grade of DTR is eligible",
"criterion": "decreased tendon reflex (DTR)",
"requirement": {
"requirement_type": "severity",
"expected_value": "any grade"
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Nervous system disorders ... resulting from prior therapy must be =< grade 2",
"criterion": "nervous system disorders",
"requirement": {
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 2,
"unit": "grade"
}
}
},
{
"exact_snippets": "decreased tendon reflex (DTR); any grade of DTR is eligible",
"criterion": "decreased tendon reflex (DTR)",
"requirement": {
"requirement_type": "severity",
"expected_value": "any grade"
}
}
]
},
{
"exact_snippets": "decreased tendon reflex (DTR); any grade of DTR is eligible",
"criterion": "decreased tendon reflex (DTR)",
"requirement": {
"requirement_type": "severity",
"expected_value": "any grade"
}
}
]
}
},
{
"identified_line": {
"line": "* Serum triglyceride level =< 300 mg/dL (no older than 7 days at the start of therapy)",
"criterions": [
{
"exact_snippets": "Serum triglyceride level =< 300 mg/dL",
"criterion": "serum triglyceride level",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 300,
"unit": "mg/dL"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Serum triglyceride level =< 300 mg/dL",
"criterion": "serum triglyceride level",
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"requirement_type": "quantity",
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"operator": "<=",
"value": 300,
"unit": "mg/dL"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "serum triglyceride level test date",
"requirement": {
"requirement_type": "recency",
"expected_value": "no older than 7 days at the start of therapy"
}
}
]
}
},
{
"identified_line": {
"line": "* Serum total cholesterol level =< 300 mg/dL (no older than 7 days at the start of therapy)",
"criterions": [
{
"exact_snippets": "Serum total cholesterol level =< 300 mg/dL",
"criterion": "serum total cholesterol level",
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"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 300,
"unit": "mg/dL"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Serum total cholesterol level =< 300 mg/dL",
"criterion": "serum total cholesterol level",
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"requirement_type": "quantity",
"expected_value": {
"operator": "<=",
"value": 300,
"unit": "mg/dL"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Random or fasting blood glucose =< the upper normal limits for age; if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age (no older than 7 days at the start of therapy)",
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{
"exact_snippets": "Random or fasting blood glucose =< the upper normal limits for age",
"criterion": "blood glucose",
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"requirement_type": "type",
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"random",
"fasting"
]
}
},
{
"exact_snippets": "Random or fasting blood glucose =< the upper normal limits for age",
"criterion": "blood glucose",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 0,
"unit": "upper normal limits for age"
}
}
},
{
"exact_snippets": "if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age",
"criterion": "follow-up fasting blood glucose",
"requirement": {
"requirement_type": "comparison",
"expected_value": {
"operator": "<=",
"value": 0,
"unit": "upper normal limits for age"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "follow-up fasting blood glucose",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Random or fasting blood glucose =< the upper normal limits for age",
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"requirement_type": "type",
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"fasting"
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},
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"operator": "<=",
"value": 0,
"unit": "upper normal limits for age"
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}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "if the initial blood glucose is a random sample that is outside of the normal limits, then follow-up fasting blood glucose can be obtained and must be =< the upper normal limits for age",
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"requirement_type": "comparison",
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"operator": "<=",
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},
{
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"requirement_type": "age",
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"operator": "<=",
"value": 7,
"unit": "days"
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}
}
]
}
]
}
]
}
},
{
"identified_line": {
"line": "* International normalized ratio (INR) =< 1.5 (no older than 7 days at the start of therapy)",
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{
"exact_snippets": "International normalized ratio (INR) =< 1.5",
"criterion": "International normalized ratio (INR)",
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"requirement_type": "value",
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"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "INR test result age",
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"requirement_type": "age",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "International normalized ratio (INR) =< 1.5",
"criterion": "International normalized ratio (INR)",
"requirement": {
"requirement_type": "value",
"expected_value": {
"operator": "<=",
"value": 1.5,
"unit": "N/A"
}
}
},
{
"exact_snippets": "no older than 7 days at the start of therapy",
"criterion": "INR test result age",
"requirement": {
"requirement_type": "age",
"expected_value": {
"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Not currently receiving anticoagulation therapy",
"criterions": [
{
"exact_snippets": "Not currently receiving anticoagulation therapy",
"criterion": "anticoagulation therapy",
"requirement": {
"requirement_type": "current status",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Not currently receiving anticoagulation therapy",
"criterion": "anticoagulation therapy",
"requirement": {
"requirement_type": "current status",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* All patients and/or their parents or legally authorized representatives must sign a written informed consent; assent, when appropriate, will be obtained according to institutional guidelines",
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{
"exact_snippets": "All patients and/or their parents or legally authorized representatives must sign a written informed consent",
"criterion": "informed consent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "assent, when appropriate, will be obtained according to institutional guidelines",
"criterion": "assent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"condition": {
"exact_snippets": "assent, when appropriate, will be obtained according to institutional guidelines",
"criterion": "assent",
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"requirement_type": "presence",
"expected_value": true
}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "All patients and/or their parents or legally authorized representatives must sign a written informed consent",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "assent, when appropriate, will be obtained according to institutional guidelines",
"criterion": "assent",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"else_criteria": {
"exact_snippets": "All patients and/or their parents or legally authorized representatives must sign a written informed consent",
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"requirement_type": "presence",
"expected_value": true
}
}
}
},
{
"identified_line": {
"line": "* Tissue blocks or slides must be sent for all patients; if tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment",
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{
"exact_snippets": "Tissue blocks or slides must be sent for all patients",
"criterion": "tissue blocks or slides",
"requirement": {
"requirement_type": "availability",
"expected_value": true
}
},
{
"exact_snippets": "if tissue blocks or slides are unavailable, the study chair must be notified",
"criterion": "notification of study chair",
"requirement": {
"requirement_type": "condition",
"expected_value": "tissue blocks or slides unavailable"
}
}
]
},
"logical_structure": {
"condition": {
"not_criteria": {
"exact_snippets": "Tissue blocks or slides must be sent for all patients",
"criterion": "tissue blocks or slides",
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"requirement_type": "availability",
"expected_value": true
}
}
},
"then_criteria": {
"exact_snippets": "if tissue blocks or slides are unavailable, the study chair must be notified",
"criterion": "notification of study chair",
"requirement": {
"requirement_type": "condition",
"expected_value": "tissue blocks or slides unavailable"
}
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirement": {
"requirement_type": "status",
"expected_value": "healthy"
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
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"requirement_type": "status",
"expected_value": "healthy"
}
}
]
}
},
{
"identified_line": {
"line": "Must have minimum age of 12 Months",
"criterions": [
{
"exact_snippets": "minimum age of 12 Months",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "Months"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "minimum age of 12 Months",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "Months"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must have maximum age of 21 Years",
"criterions": [
{
"exact_snippets": "maximum age of 21 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "maximum age of 21 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
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"operator": "<=",
"value": 21,
"unit": "Years"
}
}
}
]
}
}
],
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{
"identified_line": {
"line": "* Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies; pregnancy tests must be obtained in girls who are post-menarchal; males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method both during and for 6 months after participation in this study; abstinence is an acceptable method of contraception",
"criterions": [
{
"exact_snippets": "Pregnant ... will not be entered on this study",
"criterion": "pregnancy",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "breast-feeding ... will not be entered on this study",
"criterion": "breast-feeding",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pregnancy tests must be obtained in girls who are post-menarchal",
"criterion": "pregnancy test",
"requirement": {
"requirement_type": "necessity",
"expected_value": true
}
},
{
"exact_snippets": "males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method",
"criterion": "contraceptive use",
"requirement": {
"requirement_type": "agreement",
"expected_value": true
}
},
{
"exact_snippets": "abstinence is an acceptable method of contraception",
"criterion": "abstinence",
"requirement": {
"requirement_type": "acceptability",
"expected_value": true
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"or_criteria": [
{
"exact_snippets": "Pregnant ... will not be entered on this study",
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"expected_value": false
}
},
{
"exact_snippets": "breast-feeding ... will not be entered on this study",
"criterion": "breast-feeding",
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"requirement_type": "presence",
"expected_value": false
}
}
]
},
{
"exact_snippets": "pregnancy tests must be obtained in girls who are post-menarchal",
"criterion": "pregnancy test",
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"requirement_type": "necessity",
"expected_value": true
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},
{
"or_criteria": [
{
"exact_snippets": "males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method",
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}
},
{
"exact_snippets": "abstinence is an acceptable method of contraception",
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"requirement_type": "acceptability",
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}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid",
"criterions": [
{
"exact_snippets": "Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment",
"criterion": "corticosteroid dose stability",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable or decreasing"
}
},
{
"exact_snippets": "Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment",
"criterion": "corticosteroid dose stability",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 7,
"unit": "days"
}
}
},
{
"exact_snippets": "if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of corticosteroid",
"criterion": "time since last corticosteroid dose",
"requirement": {
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 14,
"unit": "days"
}
}
}
]
},
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"requirement_type": "duration",
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"operator": ">=",
"value": 14,
"unit": "days"
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}
},
"then_criteria": {
"and_criteria": [
{
"exact_snippets": "Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment",
"criterion": "corticosteroid dose stability",
"requirement": {
"requirement_type": "stability",
"expected_value": "stable or decreasing"
}
},
{
"exact_snippets": "Patients receiving corticosteroids must have been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment",
"criterion": "corticosteroid dose stability",
"requirement": {
"requirement_type": "duration",
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"operator": ">=",
"value": 7,
"unit": "days"
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}
}
]
},
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}
},
{
"identified_line": {
"line": "* Patients who are currently receiving other anti-cancer agents are not eligible",
"criterions": [
{
"exact_snippets": "Patients who are currently receiving other anti-cancer agents",
"criterion": "current anti-cancer agent use",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"not_criteria": {
"exact_snippets": "Patients who are currently receiving other anti-cancer agents",
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"requirement_type": "presence",
"expected_value": false
}
}
}
},
{
"identified_line": {
"line": "* Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment",
"criterions": [
{
"exact_snippets": "Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment",
"criterion": "enzyme-inducing anticonvulsants",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 7,
"unit": "days"
}
]
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Patients must not have received enzyme-inducing anticonvulsants for at least 7 days prior to enrollment",
"criterion": "enzyme-inducing anticonvulsants",
"requirement": {
"requirement_type": "time since last administration",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 7,
"unit": "days"
}
]
}
}
}
}
},
{
"identified_line": {
"line": "* Patients with a history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics, temsirolimus/other mTOR inhibitors, temozolomide or irinotecan are not eligible",
"criterions": [
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics",
"criterion": "allergic reactions to macrolide and ketolide antibiotics",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... temsirolimus/other mTOR inhibitors",
"criterion": "allergic reactions to temsirolimus/other mTOR inhibitors",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... temozolomide",
"criterion": "allergic reactions to temozolomide",
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"expected_value": false
}
},
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... irinotecan",
"criterion": "allergic reactions to irinotecan",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including macrolide and ketolide antibiotics",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... temsirolimus/other mTOR inhibitors",
"criterion": "allergic reactions to temsirolimus/other mTOR inhibitors",
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}
},
{
"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... temozolomide",
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"exact_snippets": "history of allergic reactions attributed to compounds of similar composition, including ... irinotecan",
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]
}
},
{
"identified_line": {
"line": "* Patients who have had or are planning to have the following invasive procedures are not eligible:",
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{
"exact_snippets": "Patients who have had or are planning to have the following invasive procedures",
"criterion": "invasive procedures",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
{
"exact_snippets": "Patients who have had or are planning to have the following invasive procedures",
"criterion": "invasive procedures",
"requirement": {
"requirement_type": "future plans",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Patients who have had or are planning to have the following invasive procedures",
"criterion": "invasive procedures",
"requirement": {
"requirement_type": "history",
"expected_value": false
}
},
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"exact_snippets": "Patients who have had or are planning to have the following invasive procedures",
"criterion": "invasive procedures",
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"requirement_type": "future plans",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterions": [
{
"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterion": "major surgical procedure",
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"operator": "<=",
"value": 28,
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}
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"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
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"operator": "<=",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterion": "open biopsy",
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"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
},
{
"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterion": "significant traumatic injury",
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"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
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}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterion": "major surgical procedure",
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"operator": "<=",
"value": 28,
"unit": "days"
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}
}
]
},
{
"and_criteria": [
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}
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},
{
"and_criteria": [
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"value": 28,
"unit": "days"
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}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Major surgical procedure, laparoscopic procedure, open biopsy or significant traumatic injury within 28 days prior to enrollment",
"criterion": "significant traumatic injury",
"requirement": {
"requirement_type": "time since occurrence",
"expected_value": {
"operator": "<=",
"value": 28,
"unit": "days"
}
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Subcutaneous port placement or central line placement is not considered major surgery; external central lines must be placed at least 3 days prior to enrollment and subcutaneous ports must be placed at least 7 days prior to enrollment",
"criterions": [
{
"exact_snippets": "external central lines must be placed at least 3 days prior to enrollment",
"criterion": "external central line placement",
"requirement": {
"requirement_type": "timing",
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"operator": ">=",
"value": 3,
"unit": "days prior to enrollment"
}
}
},
{
"exact_snippets": "subcutaneous ports must be placed at least 7 days prior to enrollment",
"criterion": "subcutaneous port placement",
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"requirement_type": "timing",
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"operator": ">=",
"value": 7,
"unit": "days prior to enrollment"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "external central lines must be placed at least 3 days prior to enrollment",
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"operator": ">=",
"value": 3,
"unit": "days prior to enrollment"
}
}
},
{
"exact_snippets": "subcutaneous ports must be placed at least 7 days prior to enrollment",
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"operator": ">=",
"value": 7,
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}
}
}
]
}
},
{
"identified_line": {
"line": "* Core biopsy within 7 days prior to enrollment",
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{
"exact_snippets": "Core biopsy within 7 days prior to enrollment",
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"requirement_type": "timing",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Core biopsy within 7 days prior to enrollment",
"criterion": "core biopsy",
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"requirement_type": "timing",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Fine needle aspirate within 7 days prior to enrollment",
"criterions": [
{
"exact_snippets": "Fine needle aspirate within 7 days prior to enrollment",
"criterion": "fine needle aspirate",
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"requirement_type": "timing",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "Fine needle aspirate within 7 days prior to enrollment",
"criterion": "fine needle aspirate",
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"requirement_type": "timing",
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"operator": "<=",
"value": 7,
"unit": "days"
}
}
}
}
},
{
"identified_line": {
"line": "* NOTE: For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within 14 days prior to start of protocol therapy",
"criterions": [
{
"exact_snippets": "bone marrow aspirate and biopsy are not considered surgical procedures",
"criterion": "bone marrow aspirate and biopsy",
"requirement": {
"requirement_type": "classification",
"expected_value": "not considered surgical procedures"
}
},
{
"exact_snippets": "permitted within 14 days prior to start of protocol therapy",
"criterion": "bone marrow aspirate and biopsy",
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"requirement_type": "timing",
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"operator": "<=",
"value": 14,
"unit": "days prior to start of protocol therapy"
}
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "bone marrow aspirate and biopsy are not considered surgical procedures",
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"requirement_type": "classification",
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}
},
{
"exact_snippets": "permitted within 14 days prior to start of protocol therapy",
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"requirement_type": "timing",
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"operator": "<=",
"value": 14,
"unit": "days prior to start of protocol therapy"
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with current deep vein thrombosis or deep vein thrombosis within the past 6 months are not eligible",
"criterions": [
{
"exact_snippets": "current deep vein thrombosis",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "deep vein thrombosis within the past 6 months",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
},
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"or_criteria": [
{
"exact_snippets": "current deep vein thrombosis",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "deep vein thrombosis within the past 6 months",
"criterion": "deep vein thrombosis",
"requirement": {
"requirement_type": "time since last occurrence",
"expected_value": {
"comparisons": [
{
"operator": "<=",
"value": 6,
"unit": "months"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with a history of, or current grade 4 depression are not eligible",
"criterions": [
{
"exact_snippets": "history of, or current grade 4 depression",
"criterion": "depression",
"requirement": {
"requirement_type": "severity",
"expected_value": "grade 4"
}
},
{
"exact_snippets": "history of, or current grade 4 depression",
"criterion": "depression",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"exact_snippets": "history of, or current grade 4 depression",
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"requirement_type": "severity",
"expected_value": "grade 4"
}
},
{
"exact_snippets": "history of, or current grade 4 depression",
"criterion": "depression",
"requirement": {
"requirement_type": "history",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have an uncontrolled infection are not eligible",
"criterions": [
{
"exact_snippets": "uncontrolled infection",
"criterion": "infection",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "uncontrolled infection",
"criterion": "infection",
"requirement": {
"requirement_type": "control",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible",
"criterions": [
{
"exact_snippets": "may not be able to comply with the safety monitoring requirements",
"criterion": "ability to comply with safety monitoring requirements",
"requirement": {
"requirement_type": "compliance",
"expected_value": true
}
}
]
},
"logical_structure": {
"not_criteria": {
"exact_snippets": "may not be able to comply with the safety monitoring requirements",
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"requirement_type": "compliance",
"expected_value": true
}
}
}
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Patients must have either measurable or evaluable disease",
"criterions": [
{
"exact_snippets": "measurable or evaluable disease",
"criterion": "disease status",
"requirement": {
"requirement_type": "status",
"expected_value": [
"measurable",
"evaluable"
]
}
}
]
},
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{
"exact_snippets": "measurable or evaluable disease",
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"requirement_type": "status",
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}
},
{
"exact_snippets": "measurable or evaluable disease",
"criterion": "disease status",
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"requirement_type": "status",
"expected_value": "evaluable"
}
}
]
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Patients who are currently receiving another investigational drug are not eligible",
"criterions": [
{
"exact_snippets": "Patients who are currently receiving another investigational drug",
"criterion": "receiving another investigational drug",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Patients who are currently receiving another investigational drug",
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"requirement_type": "presence",
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}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial",
"criterions": [
{
"exact_snippets": "Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease",
"criterion": "use of agents to prevent graft-versus-host disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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{
"exact_snippets": "Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others) are not eligible",
"criterions": [
{
"exact_snippets": "Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others)",
"criterion": "therapeutic anticoagulants",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Patients who are currently receiving therapeutic anticoagulants (including aspirin, low molecular weight heparin, and others)",
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"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients must not be receiving any strong CYP3A4 or P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment; moderate inducers or inhibitors of CYP3A4 and P-gp should also be avoided during ABI-009 treatment, if possible",
"criterions": [
{
"exact_snippets": "Patients must not be receiving any strong CYP3A4 ... inducers or inhibitors within 7 days prior to enrollment",
"criterion": "CYP3A4 inducers or inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "Patients must not be receiving any strong ... P-glycoprotein (P-gp) inducers or inhibitors within 7 days prior to enrollment",
"criterion": "P-glycoprotein (P-gp) inducers or inhibitors",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "moderate inducers or inhibitors of CYP3A4 ... should also be avoided during ABI-009 treatment, if possible",
"criterion": "moderate CYP3A4 inducers or inhibitors",
"requirement": {
"requirement_type": "avoidance",
"expected_value": true
}
},
{
"exact_snippets": "moderate ... inducers or inhibitors of ... P-gp should also be avoided during ABI-009 treatment, if possible",
"criterion": "moderate P-glycoprotein (P-gp) inducers or inhibitors",
"requirement": {
"requirement_type": "avoidance",
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}
}
]
},
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"exact_snippets": "failed",
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"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Patients with interstitial lung disease and/or pneumonitis are not eligible",
"criterions": [
{
"exact_snippets": "Patients with interstitial lung disease",
"criterion": "interstitial lung disease",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "pneumonitis are not eligible",
"criterion": "pneumonitis",
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"expected_value": false
}
}
]
},
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{
"exact_snippets": "Patients with interstitial lung disease",
"criterion": "interstitial lung disease",
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"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "pneumonitis are not eligible",
"criterion": "pneumonitis",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients with hypersensitivity to albumin are not eligible",
"criterions": [
{
"exact_snippets": "hypersensitivity to albumin",
"criterion": "hypersensitivity to albumin",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "hypersensitivity to albumin",
"criterion": "hypersensitivity to albumin",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have received a prior solid organ transplantation are not eligible",
"criterions": [
{
"exact_snippets": "Patients who have received a prior solid organ transplantation",
"criterion": "prior solid organ transplantation",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Patients who have received a prior solid organ transplantation",
"criterion": "prior solid organ transplantation",
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"requirement_type": "presence",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "* Patients who have known bone marrow involvement are not eligible",
"criterions": [
{
"exact_snippets": "known bone marrow involvement",
"criterion": "bone marrow involvement",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "known bone marrow involvement",
"criterion": "bone marrow involvement",
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"expected_value": true
}
}
]
}
}
],
"failed_miscellaneous": []
}