informed consent
Item
1. informed consent obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject)
boolean
C0021430 (UMLS CUI [1])
AML
Item
2. acute myeloid leukaemia (aml) according to who criteria
boolean
C0023467 (UMLS CUI [1])
complete remission
Item
3. morphological complete remission (cr) defined according to nci criteria, or cri with incomplete platelet count recovery only after 1 or 2 cycles of induction chemotherapy, and at least 1, and maximally 6 cycles of consolidation chemotherapy:
boolean
C0677874 (UMLS CUI [1])
C0392920 (UMLS CUI [2])
neutrophile count
Item
absolute neutrophile count > 1x 109/l
boolean
C0200633 (UMLS CUI [1])
platelets
Item
platelets > 80x109/l
boolean
C0005821 (UMLS CUI [1])
independency of blood transfusions
Item
independency of blood transfusions
boolean
C1879316 (UMLS CUI [1])
blasts in bone marrow
Item
less than 5% blasts in bone-marrow
boolean
C1982687 (UMLS CUI [1])
auer rods
Item
no auer rods
boolean
C0333828 (UMLS CUI [1])
no symptoms
Item
no symptoms of disease
boolean
C0037088 (UMLS CUI [1])
life expectancy
Item
4. life expectancy > 4 months as judged by the investigator
boolean
C0023671 (UMLS CUI [1])
age
Item
5. the patient is > or = 60 years of age but < or = 80 years of age
boolean
C0001779 (UMLS CUI [1])
subject participation status
Item
6. the patient has completed participation in the iph2101-101(previously nn1975-1733)trial with an acceptable safety profile, as judged by the investigator or is screened for the additional cohort
boolean
C2348568 (UMLS CUI [1])
chemotherapy time
Item
7. time since last dose of chemotherapy at least 30 days and no more than 60 days if the patient did not participate in iph2101-101 trial before
boolean
C0392920 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
recovery from acute toxicity
Item
8. recovery from acute toxicities of all previous anti-leukaemic therapies
boolean
C0013221 (UMLS CUI [1,1])
C2004454 (UMLS CUI [1,2])
kir-expression
Item
9. kir-expression on patient nk-cells (ability to bind anti-kir(1-7f9)) if the patient did not participate in iph2101-101 trial before
boolean
C0665952 (UMLS CUI [1])
ecog
Item
10. ecog performance status 0, 1 or 2
boolean
C1520224 (UMLS CUI [1])
organ function
Item
11. no major organ dysfunction as judged by the investigator
boolean
C0678852 (UMLS CUI [1])
laboratory values
Item
12. the patients must have the following clinical laboratory values:
boolean
C0022885 (UMLS CUI [1])
creatinine
Item
serum creatinine < or = 2 md/dl
boolean
C0201976 (UMLS CUI [1])
bilirubin
Item
total bilirubin < or = 1.5 x the upper limit of normal
boolean
C1278039 (UMLS CUI [1])
AST
Item
asparatate aminotransferase (ast) < 3x the upper limit of normal
boolean
C0201899 (UMLS CUI [1])
hypersensitivity to trial product or related products
Item
1. known or suspected allergy to trial product or related products
boolean
C0020517 (UMLS CUI [1])
participation status
Item
2. previous participation in this trial
boolean
C2348568 (UMLS CUI [1])
APL
Item
3. aml classified as fab m3 (apl, acute promyelocytic leukaemia) or with good prognosis aml i.e. t(8;21)(q22;q22) or inv(16)(p13q22) or t(16;16)(p13;q22) or their molecular equivalents
boolean
C0023487 (UMLS CUI [1])
eligibility for allogeneic haematopoietic transplantation
Item
4. eligibility for allogeneic haematopoietic transplantation
boolean
C1705576 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
concurrent other investigational therapy
Item
5. the patient is currently receiving, or has within the last 4 weeks received other investigational anti-leukemic treatment such as cytokine treatment, except anti-kir(1-7f9)
boolean
C0949266 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
g-csf treatment time
Item
6. the patient has received g-csf treatment within the last 30 days prior to screening
boolean
C0079459 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
steroids time
Item
7. systemic steroid treatment within the last 4 weeks prior to screening
boolean
C0038317 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
autoimmune disease
Item
8. patient has active autoimmune disease
boolean
C0004364 (UMLS CUI [1])
monoclonal gammopathy
Item
9. diagnosis of monoclonal gammopathy
boolean
C1136085 (UMLS CUI [1])
active infection
Item
10. patient has active infectious disease
boolean
C0009450 (UMLS CUI [1])
cns leukemia
Item
11. previous leukaemic cns involvement
boolean
C1332884 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
cardiac failure
Item
12. cardiac failure (new york heart association [nyha] grade iii-iv)
boolean
C1275491 (UMLS CUI [1])
LVEF
Item
13. left ventricular ejection fraction (lvef) less than 45 % of normal evaluated by ultrasound or isotopic evaluation
boolean
C0428772 (UMLS CUI [1])
comorbidity
Item
14. severe neurological/psychiatric disorder
boolean
C0009488 (UMLS CUI [1])
hiv or chronic hepatitis
Item
15. hiv or chronic hepatitis infection
boolean
C0019682 (UMLS CUI [1,1])
C0494786 (UMLS CUI [1,2])
second malignancy
Item
16. clinical evidence of an active second malignancy
boolean
C0006826 (UMLS CUI [1,1])
C0205436 (UMLS CUI [1,2])
comprehension problems limiting study protocol
Item
17. mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
boolean
C0021430 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
comorbidity limiting study protocol
Item
18. any new medical condition that in the opinion of the investigator disqualifies the patient for inclusion
boolean
C1321605 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])