{
"info": {
"nct_id": "NCT03802773",
"official_title": "Cord Blood Transplantation With Myeloablative Conditioning and Post-transplant Cyclophosphamide in Patients With Hematological Malignancies (The COmPACt Study)",
"inclusion_criteria": "* Age: ≥ 18 ≤ 75 years old\n* CB unit transplantation (TNC> 2,0 x10^7/kg and > 4/6 loci HLA matched)\n* Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine\n* GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF\n* Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.\nHealthy volunteers allowed\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Positive serologic markers for human immunodeficiency virus (HIV)\n* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"identified_line": {
"line": "* Age: ≥ 18 ≤ 75 years old",
"criterions": [
{
"exact_snippets": "Age: ≥ 18 ≤ 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "Age: ≥ 18 ≤ 75 years old",
"criterion": "age",
"requirement": {
"requirement_type": "N/A",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 18,
"unit": "years"
},
{
"operator": "<=",
"value": 75,
"unit": "years"
}
]
}
}
}
]
}
},
{
"identified_line": {
"line": "* CB unit transplantation (TNC> 2,0 x10^7/kg and > 4/6 loci HLA matched)",
"criterions": [
{
"exact_snippets": "CB unit transplantation",
"criterion": "CB unit transplantation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "TNC> 2,0 x10^7/kg",
"criterion": "TNC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2.0,
"unit": "x10^7/kg"
}
}
},
{
"exact_snippets": "> 4/6 loci HLA matched",
"criterion": "HLA loci match",
"requirement": {
"requirement_type": "match level",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "loci"
}
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"and_criteria": [
{
"exact_snippets": "CB unit transplantation",
"criterion": "CB unit transplantation",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "TNC> 2,0 x10^7/kg",
"criterion": "TNC",
"requirement": {
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 2.0,
"unit": "x10^7/kg"
}
}
}
]
},
{
"exact_snippets": "> 4/6 loci HLA matched",
"criterion": "HLA loci match",
"requirement": {
"requirement_type": "match level",
"expected_value": {
"operator": ">",
"value": 4,
"unit": "loci"
}
}
}
]
}
},
{
"identified_line": {
"line": "* GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5) CSA and MMF",
"criterions": [
{
"exact_snippets": "GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5)",
"criterion": "GVHD prophylaxis",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"PT-Cy (30 mg/kg or more on days + 3and +5)",
"CSA",
"MMF"
]
}
}
]
},
"logical_structure": {
"and_criteria": [
{
"exact_snippets": "GVHD prophylaxis including PT-Cy (30 mg/kg or more on days + 3and +5)",
"criterion": "GVHD prophylaxis",
"requirement": {
"requirement_type": "inclusion",
"expected_value": [
"PT-Cy (30 mg/kg or more on days + 3and +5)",
"CSA",
"MMF"
]
}
}
]
}
}
],
"exclusion_lines": [],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"identified_line": {
"line": "* Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterions": [
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": [
"Thiotepa",
"Busulfan",
"Fludarabine",
"TBI"
]
}
}
]
},
"logical_structure": {
"or_criteria": [
{
"and_criteria": [
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": "Thiotepa"
}
},
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": "Busulfan"
}
},
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": "Fludarabine"
}
}
]
},
{
"and_criteria": [
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": "TBI"
}
},
{
"exact_snippets": "Myeloablative conditioning regimen consisting of either Thiotepa/ Busulfan/ Fludarabine or TBI/ Fludarabine",
"criterion": "myeloablative conditioning regimen",
"requirement": {
"requirement_type": "components",
"expected_value": "Fludarabine"
}
}
]
}
]
}
},
{
"identified_line": {
"line": "* Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, high risk Acute Lymphoblastic Leukemia (ALL), Bi phenotypic/undifferentiated leukemia, Chronic Myeloid Leukemia resistant to TK inhibitors, Ph-neg Myeloproliferative Neoplasms, resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant.",
"criterions": [
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: Acute Myeloid Leukemia (AML)",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "Acute Myeloid Leukemia (AML)"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... Myelodysplastic Syndrome",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "Myelodysplastic Syndrome"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... high risk Acute Lymphoblastic Leukemia (ALL)",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "high risk Acute Lymphoblastic Leukemia (ALL)"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... Bi phenotypic/undifferentiated leukemia",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "Bi phenotypic/undifferentiated leukemia"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... Chronic Myeloid Leukemia resistant to TK inhibitors",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "Chronic Myeloid Leukemia resistant to TK inhibitors"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... Ph-neg Myeloproliferative Neoplasms",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "Ph-neg Myeloproliferative Neoplasms"
}
},
{
"exact_snippets": "Diagnosis of 1 of the following hematological malignancies: ... resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant",
"criterion": "hematological malignancy",
"requirement": {
"requirement_type": "type",
"expected_value": "resistant/relapsing Non-Hodgkin's lymphoma ineligible for an autologous transplant"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"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": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirement": {
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirement": {
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_exclusion": [
{
"identified_line": {
"line": "* Positive serologic markers for human immunodeficiency virus (HIV)",
"criterions": [
{
"exact_snippets": "Positive serologic markers for human immunodeficiency virus (HIV)",
"criterion": "HIV serologic markers",
"requirement": {
"requirement_type": "presence",
"expected_value": "positive"
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
},
{
"identified_line": {
"line": "* Acute hepatitis B virus (HBV) or acute hepatitis C virus (HCV) infection",
"criterions": [
{
"exact_snippets": "Acute hepatitis B virus (HBV) infection",
"criterion": "acute hepatitis B virus infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
},
{
"exact_snippets": "Acute hepatitis C virus (HCV) infection",
"criterion": "acute hepatitis C virus infection",
"requirement": {
"requirement_type": "presence",
"expected_value": true
}
}
]
},
"logical_structure": {
"exact_snippets": "failed",
"criterion": "failed",
"requirement": {
"requirement_type": "failed",
"expected_value": "failed"
}
}
}
],
"failed_miscellaneous": []
}