ID

13759

Beskrivning

A Safety and Tolerability Extension Trial Assessing Repeated Dosing of Anti-KIR (1-7F9) Human Monoclonal Antibody in Patients With Acute Myeloid Leukaemia; ODM derived from: https://clinicaltrials.gov/show/NCT01256073

Länk

https://clinicaltrials.gov/show/NCT01256073

Nyckelord

Versioner (1)
  1. 2016-03-03 2016-03-03 -
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CC BY-NC 3.0

Uppladdad den

3 mars 2016

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01256073

Engelsk

Eligibility Acute Myeloid Leukemia NCT01256073

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
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)
Beskrivning

informed consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
2. acute myeloid leukaemia (aml) according to who criteria
Beskrivning

AML

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
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:
Beskrivning

complete remission

Datatyp

boolean

Alias
UMLS CUI [1]
C0677874
UMLS CUI [2]
C0392920
absolute neutrophile count > 1x 109/l
Beskrivning

neutrophile count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelets > 80x109/l
Beskrivning

platelets

Datatyp

boolean

Alias
UMLS CUI [1]
C0005821
independency of blood transfusions
Beskrivning

independency of blood transfusions

Datatyp

boolean

Alias
UMLS CUI [1]
C1879316
less than 5% blasts in bone-marrow
Beskrivning

blasts in bone marrow

Datatyp

boolean

Alias
UMLS CUI [1]
C1982687
no auer rods
Beskrivning

auer rods

Datatyp

boolean

Alias
UMLS CUI [1]
C0333828
no symptoms of disease
Beskrivning

no symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0037088
4. life expectancy > 4 months as judged by the investigator
Beskrivning

life expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
5. the patient is > or = 60 years of age but < or = 80 years of age
Beskrivning

age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
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
Beskrivning

subject participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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
Beskrivning

chemotherapy time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0040223
8. recovery from acute toxicities of all previous anti-leukaemic therapies
Beskrivning

recovery from acute toxicity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013221
UMLS CUI [1,2]
C2004454
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
Beskrivning

kir-expression

Datatyp

boolean

Alias
UMLS CUI [1]
C0665952
10. ecog performance status 0, 1 or 2
Beskrivning

ecog

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
11. no major organ dysfunction as judged by the investigator
Beskrivning

organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
12. the patients must have the following clinical laboratory values:
Beskrivning

laboratory values

Datatyp

boolean

Alias
UMLS CUI [1]
C0022885
serum creatinine < or = 2 md/dl
Beskrivning

creatinine

Datatyp

boolean

Alias
UMLS CUI [1]
C0201976
total bilirubin < or = 1.5 x the upper limit of normal
Beskrivning

bilirubin

Datatyp

boolean

Alias
UMLS CUI [1]
C1278039
asparatate aminotransferase (ast) < 3x the upper limit of normal
Beskrivning

AST

Datatyp

boolean

Alias
UMLS CUI [1]
C0201899
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. known or suspected allergy to trial product or related products
Beskrivning

hypersensitivity to trial product or related products

Datatyp

boolean

Alias
UMLS CUI [1]
C0020517
2. previous participation in this trial
Beskrivning

participation status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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
Beskrivning

APL

Datatyp

boolean

Alias
UMLS CUI [1]
C0023487
4. eligibility for allogeneic haematopoietic transplantation
Beskrivning

eligibility for allogeneic haematopoietic transplantation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1705576
UMLS CUI [1,2]
C0013893
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)
Beskrivning

concurrent other investigational therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0205420
6. the patient has received g-csf treatment within the last 30 days prior to screening
Beskrivning

g-csf treatment time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0079459
UMLS CUI [1,2]
C0040223
7. systemic steroid treatment within the last 4 weeks prior to screening
Beskrivning

steroids time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C0040223
8. patient has active autoimmune disease
Beskrivning

autoimmune disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0004364
9. diagnosis of monoclonal gammopathy
Beskrivning

monoclonal gammopathy

Datatyp

boolean

Alias
UMLS CUI [1]
C1136085
10. patient has active infectious disease
Beskrivning

active infection

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
11. previous leukaemic cns involvement
Beskrivning

cns leukemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1332884
UMLS CUI [1,2]
C0205156
12. cardiac failure (new york heart association [nyha] grade iii-iv)
Beskrivning

cardiac failure

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
13. left ventricular ejection fraction (lvef) less than 45 % of normal evaluated by ultrasound or isotopic evaluation
Beskrivning

LVEF

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
14. severe neurological/psychiatric disorder
Beskrivning

comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
15. hiv or chronic hepatitis infection
Beskrivning

hiv or chronic hepatitis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019682
UMLS CUI [1,2]
C0494786
16. clinical evidence of an active second malignancy
Beskrivning

second malignancy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006826
UMLS CUI [1,2]
C0205436
17. mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation
Beskrivning

comprehension problems limiting study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0162340
18. any new medical condition that in the opinion of the investigator disqualifies the patient for inclusion
Beskrivning

comorbidity limiting study protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
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Similar models

Eligibility Acute Myeloid Leukemia NCT01256073

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
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])
Item Group
C0680251 (UMLS CUI)
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])
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