{
"info": {
"nct_id": "NCT01334060",
"official_title": "WT1 Immunity Via DNA Fusion Gene Vaccination in Haematological Malignancies by Intramuscular Injection Followed by Intramuscular Electroporation",
"inclusion_criteria": "* CML patients:\n\nPhiladelphia chromosome positive CML in chronic phase, in complete cytogenetic response (CCyR) but with detectable BCR-ABL transcripts and maintained the CCyR on imatinib monotherapy for a minimum of 24 months\n\nAML patients:\n\nWT1+ AML in CR or morphologic CR with incomplete blood count recovery (CRi);\n\nAll patients:\n\n* ≥ 18 years of age, written informed consent\n* Performance status of 0 or 1.\n* for vaccination groups: HLA-A0201 positive in at least one allele\n* for control groups: HLA A2 negative in both alleles\n* renal function and liver function (Creatinine <1.5 x upper limit of normal, liver function tests < 1.5 x upper limit of normal); Lymphocyte count > 1.0 x109/l; normal clotting\n* HB>100 g/l\n* Adequate venous access for repeated blood sampling according to protocol schedule.\n* If sexually active and possibly fertile, patients must agree to use appropriate contraceptive methods during the trial and for six months afterwards.\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
"exclusion_criteria": "* CML patients:\n\n * CML in accelerated phase or blast crisis or having achieved CMR at any point during imatinib therapy.\n * Imatinib dose modification in the previous year, Imatinib interruption for more than 15 days in the previous 6 months to enrolment\n * Prior interferon-α therapy\n * hypocellular bone marrow (<20%)\n * Complete molecular response (CMR)\n\nAML patients:\n\n* AML in haematological relapse or eligible for allogeneic SCT.\n* hypocellular bone marrow (<20%)\n* AML patients with the \"good-risk\" abnormalities comprised by the core binding factor leukaemias (i.e., AML with the translocation (8;21) and inversion of chromosome 16, and acute promyelocytic leukaemia with the translocation (15;17))\n\nAll patients:\n\n* Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry\n* Major surgery in the preceding three to four weeks from which the patient has not yet recovered.\n* Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.\n* Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease\n* Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.\n* Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* CML patients:",
"criterions": [
{
"exact_snippets": "CML patients",
"criterion": "chronic myeloid leukemia (CML)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "Philadelphia chromosome positive CML in chronic phase, in complete cytogenetic response (CCyR) but with detectable BCR-ABL transcripts and maintained the CCyR on imatinib monotherapy for a minimum of 24 months",
"criterions": [
{
"exact_snippets": "Philadelphia chromosome positive CML",
"criterion": "Philadelphia chromosome",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "chronic phase",
"criterion": "CML phase",
"requirements": [
{
"requirement_type": "phase",
"expected_value": "chronic"
}
]
},
{
"exact_snippets": "complete cytogenetic response (CCyR)",
"criterion": "cytogenetic response",
"requirements": [
{
"requirement_type": "status",
"expected_value": "complete"
}
]
},
{
"exact_snippets": "detectable BCR-ABL transcripts",
"criterion": "BCR-ABL transcripts",
"requirements": [
{
"requirement_type": "detectability",
"expected_value": true
}
]
},
{
"exact_snippets": "maintained the CCyR on imatinib monotherapy for a minimum of 24 months",
"criterion": "CCyR maintenance on imatinib",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 24,
"unit": "months"
}
}
]
}
]
},
{
"line": "AML patients:",
"criterions": [
{
"exact_snippets": "AML patients",
"criterion": "acute myeloid leukemia (AML)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "WT1+ AML in CR or morphologic CR with incomplete blood count recovery (CRi);",
"criterions": [
{
"exact_snippets": "WT1+ AML",
"criterion": "WT1+ AML",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "CR or morphologic CR with incomplete blood count recovery (CRi)",
"criterion": "remission status",
"requirements": [
{
"requirement_type": "status",
"expected_value": [
"CR",
"CRi"
]
}
]
}
]
},
{
"line": "* ≥ 18 years of age, written informed consent",
"criterions": [
{
"exact_snippets": "≥ 18 years of age",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "years"
}
}
]
},
{
"exact_snippets": "written informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Performance status of 0 or 1.",
"criterions": [
{
"exact_snippets": "Performance status of 0 or 1.",
"criterion": "performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "* for vaccination groups: HLA-A0201 positive in at least one allele",
"criterions": [
{
"exact_snippets": "HLA-A0201 positive in at least one allele",
"criterion": "HLA-A0201",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* for control groups: HLA A2 negative in both alleles",
"criterions": [
{
"exact_snippets": "HLA A2 negative in both alleles",
"criterion": "HLA A2",
"requirements": [
{
"requirement_type": "allele status",
"expected_value": "negative in both alleles"
}
]
}
]
},
{
"line": "* renal function and liver function (Creatinine <1.5 x upper limit of normal, liver function tests < 1.5 x upper limit of normal); Lymphocyte count > 1.0 x109/l; normal clotting",
"criterions": [
{
"exact_snippets": "renal function ... Creatinine <1.5 x upper limit of normal",
"criterion": "renal function",
"requirements": [
{
"requirement_type": "Creatinine level",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "x upper limit of normal"
}
}
]
},
{
"exact_snippets": "liver function ... liver function tests < 1.5 x upper limit of normal",
"criterion": "liver function",
"requirements": [
{
"requirement_type": "liver function tests",
"expected_value": {
"operator": "<",
"value": 1.5,
"unit": "x upper limit of normal"
}
}
]
},
{
"exact_snippets": "Lymphocyte count > 1.0 x109/l",
"criterion": "Lymphocyte count",
"requirements": [
{
"requirement_type": "quantity",
"expected_value": {
"operator": ">",
"value": 1.0,
"unit": "x109/l"
}
}
]
},
{
"exact_snippets": "normal clotting",
"criterion": "clotting",
"requirements": [
{
"requirement_type": "status",
"expected_value": "normal"
}
]
}
]
},
{
"line": "* HB>100 g/l",
"criterions": [
{
"exact_snippets": "HB>100 g/l",
"criterion": "hemoglobin level",
"requirements": [
{
"requirement_type": "level",
"expected_value": {
"operator": ">",
"value": 100,
"unit": "g/l"
}
}
]
}
]
},
{
"line": "* Adequate venous access for repeated blood sampling according to protocol schedule.",
"criterions": [
{
"exact_snippets": "Adequate venous access for repeated blood sampling",
"criterion": "venous access",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* If sexually active and possibly fertile, patients must agree to use appropriate contraceptive methods during the trial and for six months afterwards.",
"criterions": [
{
"exact_snippets": "sexually active",
"criterion": "sexual activity",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "possibly fertile",
"criterion": "fertility",
"requirements": [
{
"requirement_type": "status",
"expected_value": true
}
]
},
{
"exact_snippets": "agree to use appropriate contraceptive methods",
"criterion": "contraceptive use",
"requirements": [
{
"requirement_type": "agreement",
"expected_value": true
}
]
},
{
"exact_snippets": "during the trial and for six months afterwards",
"criterion": "contraceptive use duration",
"requirements": [
{
"requirement_type": "duration",
"expected_value": "during the trial and for six months afterwards"
}
]
}
]
},
{
"line": "Healthy volunteers allowed",
"criterions": [
{
"exact_snippets": "Healthy volunteers allowed",
"criterion": "volunteer health status",
"requirements": [
{
"requirement_type": "status",
"expected_value": "healthy"
}
]
}
]
},
{
"line": "Must have minimum age of 18 Years",
"criterions": [
{
"exact_snippets": "minimum age of 18 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "minimum",
"expected_value": {
"operator": ">=",
"value": 18,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* CML patients:",
"criterions": [
{
"exact_snippets": "CML patients",
"criterion": "chronic myeloid leukemia (CML)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* CML in accelerated phase or blast crisis or having achieved CMR at any point during imatinib therapy.",
"criterions": [
{
"exact_snippets": "CML in accelerated phase",
"criterion": "CML phase",
"requirements": [
{
"requirement_type": "phase",
"expected_value": "accelerated"
}
]
},
{
"exact_snippets": "CML in ... blast crisis",
"criterion": "CML phase",
"requirements": [
{
"requirement_type": "phase",
"expected_value": "blast crisis"
}
]
},
{
"exact_snippets": "having achieved CMR at any point during imatinib therapy",
"criterion": "CMR achievement during imatinib therapy",
"requirements": [
{
"requirement_type": "achievement",
"expected_value": true
}
]
}
]
},
{
"line": "* Imatinib dose modification in the previous year, Imatinib interruption for more than 15 days in the previous 6 months to enrolment",
"criterions": [
{
"exact_snippets": "Imatinib dose modification in the previous year",
"criterion": "Imatinib dose modification",
"requirements": [
{
"requirement_type": "time frame",
"expected_value": "previous year"
}
]
},
{
"exact_snippets": "Imatinib interruption for more than 15 days in the previous 6 months to enrolment",
"criterion": "Imatinib interruption",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">",
"value": 15,
"unit": "days"
}
},
{
"requirement_type": "time frame",
"expected_value": "previous 6 months to enrolment"
}
]
}
]
},
{
"line": "* Prior interferon-α therapy",
"criterions": [
{
"exact_snippets": "Prior interferon-α therapy",
"criterion": "interferon-α therapy",
"requirements": [
{
"requirement_type": "prior treatment",
"expected_value": true
}
]
}
]
},
{
"line": "* hypocellular bone marrow (<20%)",
"criterions": [
{
"exact_snippets": "hypocellular bone marrow (<20%)",
"criterion": "bone marrow cellularity",
"requirements": [
{
"requirement_type": "cellularity",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "%"
}
}
]
}
]
},
{
"line": "* Complete molecular response (CMR)",
"criterions": [
{
"exact_snippets": "Complete molecular response (CMR)",
"criterion": "molecular response",
"requirements": [
{
"requirement_type": "completeness",
"expected_value": "complete"
}
]
}
]
},
{
"line": "AML patients:",
"criterions": [
{
"exact_snippets": "AML patients",
"criterion": "acute myeloid leukemia (AML)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* AML in haematological relapse or eligible for allogeneic SCT.",
"criterions": [
{
"exact_snippets": "AML in haematological relapse",
"criterion": "AML",
"requirements": [
{
"requirement_type": "relapse status",
"expected_value": "haematological relapse"
}
]
},
{
"exact_snippets": "eligible for allogeneic SCT",
"criterion": "allogeneic SCT eligibility",
"requirements": [
{
"requirement_type": "eligibility",
"expected_value": true
}
]
}
]
},
{
"line": "* hypocellular bone marrow (<20%)",
"criterions": [
{
"exact_snippets": "hypocellular bone marrow (<20%)",
"criterion": "bone marrow cellularity",
"requirements": [
{
"requirement_type": "cellularity",
"expected_value": {
"operator": "<",
"value": 20,
"unit": "%"
}
}
]
}
]
},
{
"line": "* AML patients with the \"good-risk\" abnormalities comprised by the core binding factor leukaemias (i.e., AML with the translocation (8;21) and inversion of chromosome 16, and acute promyelocytic leukaemia with the translocation (15;17))",
"criterions": [
{
"exact_snippets": "AML patients",
"criterion": "acute myeloid leukemia (AML)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "\"good-risk\" abnormalities",
"criterion": "good-risk abnormalities",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "core binding factor leukaemias",
"criterion": "core binding factor leukemias",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "AML with the translocation (8;21)",
"criterion": "translocation (8;21)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "inversion of chromosome 16",
"criterion": "inversion of chromosome 16",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "acute promyelocytic leukaemia with the translocation (15;17)",
"criterion": "acute promyelocytic leukemia with translocation (15;17)",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial. The predictable need of their use will preclude the patient from trial entry",
"criterions": [
{
"exact_snippets": "Systemic steroids or other drugs with a likely effect on immune competence are forbidden during the trial.",
"criterion": "use of systemic steroids or other drugs affecting immune competence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "The predictable need of their use will preclude the patient from trial entry",
"criterion": "predictable need for systemic steroids or other drugs affecting immune competence",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Major surgery in the preceding three to four weeks from which the patient has not yet recovered.",
"criterions": [
{
"exact_snippets": "Major surgery in the preceding three to four weeks",
"criterion": "major surgery",
"requirements": [
{
"requirement_type": "time since surgery",
"expected_value": {
"comparisons": [
{
"operator": ">=",
"value": 3,
"unit": "weeks"
},
{
"operator": "<=",
"value": 4,
"unit": "weeks"
}
]
}
}
]
},
{
"exact_snippets": "from which the patient has not yet recovered",
"criterion": "recovery from surgery",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": false
}
]
}
]
},
{
"line": "* Patients who are of high medical risk because of non-malignant systemic disease, as well as those with active uncontrolled infection.",
"criterions": [
{
"exact_snippets": "high medical risk because of non-malignant systemic disease",
"criterion": "non-malignant systemic disease",
"requirements": [
{
"requirement_type": "risk level",
"expected_value": "high"
}
]
},
{
"exact_snippets": "active uncontrolled infection",
"criterion": "infection",
"requirements": [
{
"requirement_type": "control status",
"expected_value": "uncontrolled"
},
{
"requirement_type": "activity status",
"expected_value": "active"
}
]
}
]
},
{
"line": "* Patients with any other condition which in the Investigator's opinion would not make the patient a good candidate for the clinical trial, such as concurrent congestive heart failure or prior history of New York Heart Association (NYHA) class III/ IV cardiac disease",
"criterions": [
{
"exact_snippets": "concurrent congestive heart failure",
"criterion": "congestive heart failure",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "prior history of New York Heart Association (NYHA) class III/ IV cardiac disease",
"criterion": "NYHA class III/IV cardiac disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": false
}
]
}
]
},
{
"line": "* Current malignancies at other sites, with the exception of adequately treated basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy, have no evidence of that disease for five years and are deemed at low risk for recurrence, are eligible for the study.",
"criterions": [
{
"exact_snippets": "Current malignancies at other sites",
"criterion": "current malignancies at other sites",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "adequately treated basal or squamous cell carcinoma of the skin",
"criterion": "basal or squamous cell carcinoma of the skin",
"requirements": [
{
"requirement_type": "treatment adequacy",
"expected_value": true
}
]
},
{
"exact_snippets": "Cancer survivors, who have undergone potentially curative therapy for a prior malignancy",
"criterion": "prior malignancy",
"requirements": [
{
"requirement_type": "curative therapy",
"expected_value": true
}
]
},
{
"exact_snippets": "no evidence of that disease for five years",
"criterion": "evidence of prior malignancy",
"requirements": [
{
"requirement_type": "absence duration",
"expected_value": {
"operator": "=",
"value": 5,
"unit": "years"
}
}
]
},
{
"exact_snippets": "deemed at low risk for recurrence",
"criterion": "risk for recurrence",
"requirements": [
{
"requirement_type": "risk level",
"expected_value": "low"
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [
{
"line": "All patients:",
"criterions": []
}
],
"failed_exclusion": [
{
"line": "All patients:",
"criterions": []
},
{
"line": "* Patients who are serologically positive for or are known to suffer from Hepatitis B, C, Syphilis or HIV. Counselling will be offered to all patients prior to testing.",
"criterions": [
{
"exact_snippets": "serologically positive for ... Hepatitis B",
"criterion": "Hepatitis B",
"requirements": [
{
"requirement_type": "serological status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "serologically positive for ... Hepatitis C",
"criterion": "Hepatitis C",
"requirements": [
{
"requirement_type": "serological status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "serologically positive for ... Syphilis",
"criterion": "Syphilis",
"requirements": [
{
"requirement_type": "serological status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "serologically positive for ... HIV",
"criterion": "HIV",
"requirements": [
{
"requirement_type": "serological status",
"expected_value": "positive"
}
]
},
{
"exact_snippets": "known to suffer from ... Hepatitis B",
"criterion": "Hepatitis B",
"requirements": [
{
"requirement_type": "known condition",
"expected_value": true
}
]
},
{
"exact_snippets": "known to suffer from ... Hepatitis C",
"criterion": "Hepatitis C",
"requirements": [
{
"requirement_type": "known condition",
"expected_value": true
}
]
},
{
"exact_snippets": "known to suffer from ... Syphilis",
"criterion": "Syphilis",
"requirements": [
{
"requirement_type": "known condition",
"expected_value": true
}
]
},
{
"exact_snippets": "known to suffer from ... HIV",
"criterion": "HIV",
"requirements": [
{
"requirement_type": "known condition",
"expected_value": true
}
]
}
]
}
],
"failed_miscellaneous": []
}