Categories Three
Item
1. patients belong to one of three categories:
boolean
C0683312 (UMLS CUI [1,1])
C0205449 (UMLS CUI [1,2])
Myeloid neoplasm Secondary to Chemoradiotherapy | Treatment related acute myeloid leukaemia | MYELODYSPLASTIC SYNDROME | Age | Cytogenetic Analysis Unfavorable | In complete remission Malignant Neoplasm First | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma
Item
myeloid neoplasm secondary to chemo-radiotherapy (t-aml/mds) aged 60 and over with unfavorable cytogenetics (european leukemia network definition 2010), the first cancer must have been in remission for more than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C2939461 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0436307 (UMLS CUI [1,3])
C1336735 (UMLS CUI [2])
C3463824 (UMLS CUI [3])
C0001779 (UMLS CUI [4])
C0752095 (UMLS CUI [5,1])
C3640815 (UMLS CUI [5,2])
C0677874 (UMLS CUI [6,1])
C0006826 (UMLS CUI [6,2])
C0205435 (UMLS CUI [6,3])
C0007099 (UMLS CUI [7])
C0007117 (UMLS CUI [8])
C0007137 (UMLS CUI [9])
Leukemia, Myelocytic, Acute de novo Relapsed | Leukemia, Myelocytic, Acute de novo Unresponsive to Treatment | Age | Allogeneic bone marrow transplantation Not Eligible
Item
relapsed or refractory de novo aml aged 18 and over (multiple relapses allowed), regardless of the risk group, provided not being eligible for allogeneic bone marrow transplantation
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205336 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C1515568 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C0001779 (UMLS CUI [3])
C0149615 (UMLS CUI [4,1])
C1555471 (UMLS CUI [4,2])
Leukemia, Myelocytic, Acute de novo | Age | Patient unsuitable for procedure | Induction Chemotherapy Associated with Aplasia
Item
de novo aml at diagnosis, aged 60 and over and considered unfit to benefit from induction chemotherapy associated with aplasia (at the discretion of the investigator)
boolean
C0023467 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C3839996 (UMLS CUI [3])
C3179010 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0243065 (UMLS CUI [4,3])
Blood Glucose Balance normal | Hemoglobin, Glycosylated
Item
2. adequate glycemic balance defined by glycated hemoglobin ≤ 8%
boolean
C0005802 (UMLS CUI [1,1])
C0575089 (UMLS CUI [1,2])
C0017853 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Serum pregnancy test negative
Item
3. females of childbearing potential (fcbp) should receive effective contraception: a negative pregnancy blood test is required within 2 weeks before starting experimental treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0430061 (UMLS CUI [2])
ECOG performance status
Item
4. eastern cooperative oncology group (ecog) performance status (ps) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Communicable Disease Absent | Communicable Disease Severe Absent
Item
5. absence of severe or active infection
boolean
C0009450 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Cardiac function Systolic | Left ventricular ejection fraction
Item
6. adequate systolic cardiac function : left ventricular ejection fraction (lvef) ≥ 50%
boolean
C0232164 (UMLS CUI [1,1])
C0039155 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
7. adequate hepatic function: aspartate aminotransferase test (ast) and alanine aminotransferase test (alt) ≤ 3 times the upper limit of normal (uln), bilirubin ≤
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
Bilirubin, total measurement
Item
1.5 x uln
boolean
C0201913 (UMLS CUI [1])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
8. adequate renal function: serum creatinine ≤ 1.5 x uln or calculated creatinine clearance > 60 ml/min.
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Informed consent
Item
9. signed informed consent
boolean
C0021430 (UMLS CUI [1])
Impaired glucose tolerance | Diabetes Mellitus
Item
1. glucose intolerance or diabetes mellitus, treated or untreated
boolean
C0271650 (UMLS CUI [1])
C0011849 (UMLS CUI [2])
Malignant Neoplasm First | Tumor Progression | Solid tumour | Lymphoma | Malignant Neoplasm First | Cancer Remission | Carcinoma in Situ | Basal cell carcinoma | Squamous cell carcinoma
Item
2. first cancer in evolution(solid tumor or lymphoma) or in remission for less than two years, except in situ carcinoma, basal cell carcinoma and squamous cell carcinoma
boolean
C0006826 (UMLS CUI [1,1])
C0205435 (UMLS CUI [1,2])
C0178874 (UMLS CUI [2])
C0280100 (UMLS CUI [3])
C0024299 (UMLS CUI [4])
C0006826 (UMLS CUI [5,1])
C0205435 (UMLS CUI [5,2])
C0687702 (UMLS CUI [6])
C0007099 (UMLS CUI [7])
C0007117 (UMLS CUI [8])
C0007137 (UMLS CUI [9])
Leukemia, Myelocytic, Acute Secondary to MYELODYSPLASTIC SYNDROME | myeloproliferative syndrome
Item
3. aml secondary to mds or myeloproliferative syndrome (who 2008 definitions)
boolean
C0023467 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C3463824 (UMLS CUI [1,3])
C1443043 (UMLS CUI [2])
Acute Promyelocytic Leukemia de novo | Leukemia, Myelocytic, Acute FAB type M3 de novo | Acute Promyelocytic Leukemia Secondary to Therapeutic procedure | Leukemia, Myelocytic, Acute FAB type M3 Secondary to Therapeutic procedure
Item
4. acute promyelocytic leukaemia (apl or aml french american british (fab) classification 3) de novo or secondary to treatment (t-apl)
boolean
C0023487 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0023467 (UMLS CUI [2,1])
C0457329 (UMLS CUI [2,2])
C1515568 (UMLS CUI [2,3])
C0023487 (UMLS CUI [3,1])
C0175668 (UMLS CUI [3,2])
C0087111 (UMLS CUI [3,3])
C0023467 (UMLS CUI [4,1])
C0457329 (UMLS CUI [4,2])
C0175668 (UMLS CUI [4,3])
C0087111 (UMLS CUI [4,4])
Core binding factor acute myeloid leukemia de novo | Core binding factor acute myeloid leukemia Secondary
Item
5. de novo or secondary core binding factor (cbf)/aml
boolean
C3839741 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C3839741 (UMLS CUI [2,1])
C0175668 (UMLS CUI [2,2])
Leukemia, Myelocytic, Acute Philadelphia chromosome positive de novo | Leukemia, Myelocytic, Acute Philadelphia chromosome positive Secondary | t(9;22) | BCR-ABL Fusion Gene
Item
6. de novo or secondary philadelphia chromosome (ph) 1 positive aml defined by the presence of a t(9.22) or a breakpoint cluster region-abelson murine leukemia viral oncogene homolog (bcr-abl) transcript
boolean
C0023467 (UMLS CUI [1,1])
C0856536 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
C0023467 (UMLS CUI [2,1])
C0856536 (UMLS CUI [2,2])
C0175668 (UMLS CUI [2,3])
C3897138 (UMLS CUI [3])
C1835417 (UMLS CUI [4])
White Blood Cell Count procedure
Item
7. leukocytes above 30.000/mm3 (30 g/l) at enrollment
boolean
C0023508 (UMLS CUI [1])
Therapeutic procedure Antileukemic Agent | hydroxyurea
Item
8. antileukemic treatment within 15 days before enrollment, with the exception of hydroxyurea
boolean
C0087111 (UMLS CUI [1,1])
C0596112 (UMLS CUI [1,2])
C0020402 (UMLS CUI [2])
leukemia Central Nervous System Involvement
Item
9. central nervous system leukemic involvement
boolean
C0023418 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
Pregnancy | Breast Feeding | Childbearing Potential | Contraceptive methods Not used
Item
10. pregnant or lactating women, or women of childbearing potential without effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
C0700589 (UMLS CUI [4,1])
C0445107 (UMLS CUI [4,2])
Allogeneic bone marrow transplantation Previous
Item
11. prior history of allogeneic bone marrow transplantation
boolean
C0149615 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Organ Transplantation Previous | Etiology aspects | Chronic infection with HIV | HIV Severe
Item
12. prior history of organ transplantation or other cause of severe or chronic immunodeficiency human
boolean
C0029216 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2])
C0853112 (UMLS CUI [3])
C0019682 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
HIV Seropositivity | Human T-lymphotropic virus 1 | Hepatitis B | Hepatitis C
Item
13. seropositivity for human immunodeficiency virus (hiv) or human t-lymphotropic virus-1 (htlv-1) viruses, active b or c hepatitis
boolean
C0019699 (UMLS CUI [1])
C0020094 (UMLS CUI [2])
C0019163 (UMLS CUI [3])
C0019196 (UMLS CUI [4])
Study Subject Participation Status | Cancer Treatment Trial
Item
14. inclusion in another experimental anti-cancer clinical trial*
boolean
C2348568 (UMLS CUI [1])
C1516640 (UMLS CUI [2])
Monitoring Medical Unable
Item
15. patients unable to undergo medical monitoring for geographical, social or psychological issues
boolean
C1283169 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Protection of patient Legal
Item
16. patient under measure of legal protection
boolean
C0412786 (UMLS CUI [1,1])
C1301860 (UMLS CUI [1,2])
Social Security Lacking
Item
17. no social security
boolean
C0037435 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
Exclusion Period Determination | Study Subject Participation Status
Item
for ethical reasons, the exclusion period before considering the possibility of participating in another clinical study with a new experimental molecule cannot be determined, yet each case will be discussed on an individual basis with the study coordinator.
boolean
C2828389 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C1148554 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2])