{
"info": {
"nct_id": "NCT02894645",
"official_title": "Ma-Spore ALL 2010 Study",
"inclusion_criteria": "1. Confirmed diagnosis of non-Burkitt B-lineage ALL\n2. 1 to 17 years of age (before 18th birthday)\n3. Renal function within normal range for age\n4. Liver function within normal range for age\n5. Able to participate in the full 2 years of treatment\nHealthy volunteers allowed\nMust have minimum age of 1 Year\nMust have maximum age of 17 Years",
"exclusion_criteria": "1. Age less than one year or age greater than/equals to 18 years\n2. Previous treatment with cytotoxic agents or high-dose steroids\n3. Mixed phenotype acute leukemia (MPAL)\n4. ALL as secondary malignancy\n5. Abnormal renal or liver function\n6. Doubtful compliance or unable to afford full course of therapy",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "1. Confirmed diagnosis of non-Burkitt B-lineage ALL",
"criterions": [
{
"exact_snippets": [
"Confirmed diagnosis of non-Burkitt B-lineage ALL"
],
"criterion": "non-Burkitt B-lineage ALL",
"requirement_type": "diagnosis",
"expected_value": true
}
]
},
{
"line": "2. 1 to 17 years of age (before 18th birthday)",
"criterions": [
{
"exact_snippets": [
"1 to 17 years of age",
"before 18th birthday"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 1
},
{
"operator": "<",
"value": 18
}
]
}
}
]
},
{
"line": "3. Renal function within normal range for age",
"criterions": [
{
"exact_snippets": [
"Renal function within normal range for age"
],
"criterion": "renal function",
"requirement_type": "range",
"expected_value": "normal for age"
}
]
},
{
"line": "4. Liver function within normal range for age",
"criterions": [
{
"exact_snippets": [
"Liver function within normal range"
],
"criterion": "liver function",
"requirement_type": "range",
"expected_value": "normal for age"
}
]
},
{
"line": "5. Able to participate in the full 2 years of treatment",
"criterions": [
{
"exact_snippets": [
"Able to participate in the full 2 years of treatment"
],
"criterion": "participation duration",
"requirement_type": "minimum duration",
"expected_value": "2 years"
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": [
"Healthy volunteers allowed"
],
"criterion": "healthy volunteers",
"requirement_type": "participation",
"expected_value": true
}
]
},
{
"line": "Must have minimum age of 1 Year",
"criterions": [
{
"exact_snippets": [
"minimum age of 1 Year"
],
"criterion": "age",
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 1
}
}
]
},
{
"line": "Must have maximum age of 17 Years",
"criterions": [
{
"exact_snippets": [
"maximum age of 17 Years"
],
"criterion": "age",
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 17
}
}
]
}
],
"exclusion_lines": [
{
"line": "1. Age less than one year or age greater than/equals to 18 years",
"criterions": [
{
"exact_snippets": [
"Age less than one year"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": "<",
"value": 1
}
]
}
},
{
"exact_snippets": [
"age greater than/equals to 18 years"
],
"criterion": "age",
"requirement_type": "range",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18
}
]
}
}
]
},
{
"line": "2. Previous treatment with cytotoxic agents or high-dose steroids",
"criterions": [
{
"exact_snippets": [
"Previous treatment with cytotoxic agents"
],
"criterion": "cytotoxic agents",
"requirement_type": "previous treatment",
"expected_value": true
},
{
"exact_snippets": [
"Previous treatment with",
"high-dose steroids"
],
"criterion": "high-dose steroids",
"requirement_type": "previous treatment",
"expected_value": true
}
]
},
{
"line": "3. Mixed phenotype acute leukemia (MPAL)",
"criterions": [
{
"exact_snippets": [
"Mixed phenotype acute leukemia (MPAL)"
],
"criterion": "mixed phenotype acute leukemia",
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"line": "4. ALL as secondary malignancy",
"criterions": [
{
"exact_snippets": [
"ALL as secondary malignancy"
],
"criterion": "acute lymphoblastic leukemia (ALL)",
"requirement_type": "secondary malignancy",
"expected_value": true
}
]
},
{
"line": "5. Abnormal renal or liver function",
"criterions": [
{
"exact_snippets": [
"Abnormal renal"
],
"criterion": "renal function",
"requirement_type": "normality",
"expected_value": false
},
{
"exact_snippets": [
"Abnormal",
"liver function"
],
"criterion": "liver function",
"requirement_type": "normality",
"expected_value": false
}
]
},
{
"line": "6. Doubtful compliance or unable to afford full course of therapy",
"criterions": [
{
"exact_snippets": [
"Doubtful compliance"
],
"criterion": "compliance",
"requirement_type": "certainty",
"expected_value": false
},
{
"exact_snippets": [
"unable to afford full course of therapy"
],
"criterion": "affordability",
"requirement_type": "ability",
"expected_value": true
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}