{
"info": {
"nct_id": "NCT00001748",
"official_title": "HLA-Mismatched Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation for Hematological Malignancies",
"inclusion_criteria": "Healthy volunteers allowed",
"exclusion_criteria": "",
"miscellaneous_criteria": "Patient:\n\nAges 10-45 years.\n\nChronic myelogenous leukemia, any of these categories: accelerated phase or blast transformation.\n\nAcute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in any remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure including partial remission, partially responding or untreated relapse.\n\nAcute myelogenous leukemia (AML): All AML in second or subsequent remission, primary induction failure or partial remission and resistant relapse.\n\nMyelodysplastic syndromes, any of these categories: refractory anemia with excess of blasts, transformation to acute leukemia, chronic myelomonocytic leukemia.\n\nMyeloproliferative disorders undergoing transformation to terminal stages.\n\nChronic lymphocytic leukemia (CLL) in Richter transformation.\n\nHigh-grade lymphoma, refractory to standard treatment approaches, mantle cell lymphoma.\n\nNo major organ dysfunction precluding transplantation.\n\nDLCO greater than 65% predicted.\n\nLeft ventricular ejection fraction: greater than 40% predicted.\n\nECOG performance status of 0 or 1.\n\nInformed consent given. Informed consent from parents for minors.\n\nWomen of childbearing age with a negative pregnancy test may participate.\n\nDonor:\n\nPartially HLA matched family donor (3-5/6 matches).\n\nFit to receive G-CSF and give peripheral blood stem cells (normal blood count, normotensive, and no history of stroke).\n\nInformed consent given.\n\nPatients or donors must not be pregnant or nursing.\n\nMust not have ECOG performance status of 2 or more.\n\nNo severe psychiatric illness in patient or donor: Mental deficiency sufficiently severe as to make compliance with the BMT treatment unlikely and making informed consent impossible.\n\nNo major anticipated illness or organ failure incompatible with survival from BMT.\n\nDLCO must not be less than 65% predicted.\n\nNo left ventricular ejection fraction: less than 40% predicted.\n\nMust not have serum creatinine greater than 3 mg/dl.\n\nMust not have serum bilirubin greater than 4 mg/dl, Transaminases greater than 3 times the upper limit of normal.\n\nDonor or patient must not be HIV positive.\n\nMust not have history of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.\n\nDonor must be fit to receive G-CSF and undergo apheresis.\n\nMust not fail to mobilize adequate numbers of CD34+ cells after two cycles of G-CSF."
},
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"identified_line": {
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{
"operator": ">=",
"value": 10,
"unit": "years"
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{
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"exact_snippets": "Ages 10-45 years.",
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"operator": ">=",
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"expected_value": true
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{
"exact_snippets": "any of these categories: ... blast transformation",
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"and_criteria": [
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"or_criteria": [
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"exact_snippets": "any of these categories: ... blast transformation",
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"identified_line": {
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{
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{
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{
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{
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}
}
]
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{
"identified_line": {
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}
}
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"exact_snippets": "Myeloproliferative disorders undergoing transformation to terminal stages",
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}
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"and_criteria": [
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"else_criteria": null
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"exact_snippets": "Mental deficiency ... making informed consent impossible",
"criterion": "mental deficiency",
"requirement": {
"requirement_type": "severity",
"expected_value": "making informed consent impossible"
}
}
}
]
},
{
"not_criteria": {
"exact_snippets": "No severe psychiatric illness in ... donor",
"criterion": "psychiatric illness in donor",
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"requirement_type": "severity",
"expected_value": "not severe"
}
}
}
]
}
},
{
"identified_line": {
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"criterion": "major anticipated illness",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No ... organ failure incompatible with survival from BMT",
"criterion": "organ failure incompatible with survival from BMT",
"requirement": {
"requirement_type": "presence",
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}
}
]
},
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{
"exact_snippets": "No major anticipated illness",
"criterion": "major anticipated illness",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "No ... organ failure incompatible with survival from BMT",
"criterion": "organ failure incompatible with survival from BMT",
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"requirement_type": "presence",
"expected_value": false
}
}
]
}
},
{
"identified_line": {
"line": "DLCO must not be less than 65% predicted.",
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{
"exact_snippets": "DLCO must not be less than 65% predicted.",
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"operator": ">=",
"value": 65,
"unit": "%"
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}
}
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{
"exact_snippets": "DLCO must not be less than 65% predicted.",
"criterion": "DLCO",
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"operator": ">=",
"value": 65,
"unit": "%"
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}
}
]
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},
{
"identified_line": {
"line": "No left ventricular ejection fraction: less than 40% predicted.",
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{
"exact_snippets": "No left ventricular ejection fraction: less than 40%",
"criterion": "left ventricular ejection fraction",
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"requirement_type": "value",
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"operator": "<",
"value": 40,
"unit": "%"
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}
}
]
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"criterion": "left ventricular ejection fraction",
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"requirement_type": "value",
"expected_value": {
"operator": "<",
"value": 40,
"unit": "%"
}
}
}
}
},
{
"identified_line": {
"line": "Must not have serum creatinine greater than 3 mg/dl.",
"criterions": [
{
"exact_snippets": "serum creatinine greater than 3 mg/dl",
"criterion": "serum creatinine",
"requirement": {
"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "mg/dl"
}
}
}
]
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"and_criteria": [
{
"exact_snippets": "serum creatinine greater than 3 mg/dl",
"criterion": "serum creatinine",
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"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "mg/dl"
}
}
}
]
}
},
{
"identified_line": {
"line": "Must not have serum bilirubin greater than 4 mg/dl, Transaminases greater than 3 times the upper limit of normal.",
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{
"exact_snippets": "serum bilirubin greater than 4 mg/dl",
"criterion": "serum bilirubin",
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"requirement_type": "level",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Transaminases greater than 3 times the upper limit of normal",
"criterion": "Transaminases",
"requirement": {
"requirement_type": "level",
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"operator": "<=",
"value": 3,
"unit": "times the upper limit of normal"
}
}
}
]
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{
"exact_snippets": "serum bilirubin greater than 4 mg/dl",
"criterion": "serum bilirubin",
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"requirement_type": "level",
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"operator": "<=",
"value": 4,
"unit": "mg/dl"
}
}
},
{
"exact_snippets": "Transaminases greater than 3 times the upper limit of normal",
"criterion": "Transaminases",
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"requirement_type": "level",
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"operator": "<=",
"value": 3,
"unit": "times the upper limit of normal"
}
}
}
]
}
},
{
"identified_line": {
"line": "Donor or patient must not be HIV positive.",
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"exact_snippets": "Donor or patient must not be HIV positive.",
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"requirement_type": "status",
"expected_value": "negative"
}
}
]
},
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"exact_snippets": "Donor or patient must not be HIV positive.",
"criterion": "HIV status",
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"requirement_type": "status",
"expected_value": "negative"
}
}
]
}
},
{
"identified_line": {
"line": "Must not have history of other malignancies except basal cell or squamous carcinoma of the skin, positive PAP smear and subsequent negative follow up.",
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{
"exact_snippets": "Must not have history of other malignancies",
"criterion": "history of other malignancies",
"requirement": {
"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "except basal cell or squamous carcinoma of the skin",
"criterion": "basal cell or squamous carcinoma of the skin",
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"expected_value": true
}
},
{
"exact_snippets": "positive PAP smear",
"criterion": "positive PAP smear",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "subsequent negative follow up",
"criterion": "negative follow up after positive PAP smear",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
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"and_criteria": [
{
"exact_snippets": "Must not have history of other malignancies",
"criterion": "history of other malignancies",
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"requirement_type": "presence",
"expected_value": false
}
},
{
"exact_snippets": "except basal cell or squamous carcinoma of the skin",
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}
}
]
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"and_criteria": [
{
"exact_snippets": "positive PAP smear",
"criterion": "positive PAP smear",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "subsequent negative follow up",
"criterion": "negative follow up after positive PAP smear",
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"requirement_type": "presence",
"expected_value": true
}
}
]
},
"else_criteria": null
}
},
{
"identified_line": {
"line": "Donor must be fit to receive G-CSF and undergo apheresis.",
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{
"exact_snippets": "Donor must be fit to receive G-CSF",
"criterion": "fitness to receive G-CSF",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
},
{
"exact_snippets": "Donor must be fit to ... undergo apheresis",
"criterion": "fitness to undergo apheresis",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
}
]
},
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{
"exact_snippets": "Donor must be fit to receive G-CSF",
"criterion": "fitness to receive G-CSF",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
},
{
"exact_snippets": "Donor must be fit to ... undergo apheresis",
"criterion": "fitness to undergo apheresis",
"requirement": {
"requirement_type": "fitness",
"expected_value": true
}
}
]
}
},
{
"identified_line": {
"line": "Must not fail to mobilize adequate numbers of CD34+ cells after two cycles of G-CSF.",
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{
"exact_snippets": "Must not fail to mobilize adequate numbers of CD34+ cells",
"criterion": "CD34+ cell mobilization",
"requirement": {
"requirement_type": "adequacy",
"expected_value": true
}
},
{
"exact_snippets": "after two cycles of G-CSF",
"criterion": "G-CSF cycles",
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"operator": "=",
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"unit": "cycles"
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}
}
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},
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{
"and_criteria": [
{
"not_criteria": {
"not_criteria": {
"and_criteria": [
{
"exact_snippets": "Must not fail to mobilize adequate numbers of CD34+ cells",
"criterion": "CD34+ cell mobilization",
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"requirement_type": "adequacy",
"expected_value": true
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},
{
"exact_snippets": "after two cycles of G-CSF",
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"operator": "=",
"value": 2,
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}
}
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}
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}
},
{
"identified_line": {
"line": "Patient:",
"criterions": []
},
"logical_structure": {
"and_criteria": []
}
}
],
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"failed_exclusion": [],
"failed_miscellaneous": [
{
"identified_line": {
"line": "Acute lymphoblastic leukemia, any of these categories: Adults (greater than 18 years) in any remission with high-risk features (presenting leukocyte count greater than 100,000/cu mm, Karyotypes t9; 22, t4, t19, t11, biphenotypic leukemia). All second remissions, primary induction failure including partial remission, partially responding or untreated relapse.",
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"requirement_type": "presence",
"expected_value": true
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{
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"operator": ">",
"value": 18,
"unit": "years"
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}
},
{
"exact_snippets": "in any remission",
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{
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{
"exact_snippets": "presenting leukocyte count greater than 100,000/cu mm",
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"requirement_type": "count",
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"operator": ">",
"value": 100000,
"unit": "cu mm"
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"t19",
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{
"exact_snippets": "All second remissions",
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{
"exact_snippets": "partial remission",
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{
"exact_snippets": "untreated relapse",
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"criterion": "failed",
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"expected_value": "failed"
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}
},
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]
}
},
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"exact_snippets": "Myelodysplastic syndromes, any of these categories: ... transformation to acute leukemia",
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{
"exact_snippets": "Myelodysplastic syndromes, any of these categories: ... chronic myelomonocytic leukemia",
"criterion": "myelodysplastic syndromes",
"requirement": {
"requirement_type": "categories",
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]
}
}
]
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"criterion": "failed",
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"exact_snippets": "ECOG performance status of 0 or 1.",
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"requirement_type": "value",
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]
}
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]
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"criterion": "failed",
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]
}