ID

13759

Description

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

Link

https://clinicaltrials.gov/show/NCT01256073

Keywords

Versions (1)
  1. 3/3/16 3/3/16 -
Copyright Holder

CC BY-NC 3.0

Uploaded on

March 3, 2016

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Creative Commons BY-NC 3.0
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Eligibility Acute Myeloid Leukemia NCT01256073

English

Eligibility Acute Myeloid Leukemia NCT01256073

1 forms  
Inclusion Criteria
Description

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)
Description

informed consent

Data type

boolean

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

AML

Data type

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:
Description

complete remission

Data type

boolean

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

neutrophile count

Data type

boolean

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

platelets

Data type

boolean

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

independency of blood transfusions

Data type

boolean

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

blasts in bone marrow

Data type

boolean

Alias
UMLS CUI [1]
C1982687
no auer rods
Description

auer rods

Data type

boolean

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

no symptoms

Data type

boolean

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

life expectancy

Data type

boolean

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

age

Data type

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
Description

subject participation status

Data type

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
Description

chemotherapy time

Data type

boolean

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

recovery from acute toxicity

Data type

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
Description

kir-expression

Data type

boolean

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

ecog

Data type

boolean

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

organ function

Data type

boolean

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

laboratory values

Data type

boolean

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

creatinine

Data type

boolean

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

bilirubin

Data type

boolean

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

AST

Data type

boolean

Alias
UMLS CUI [1]
C0201899
Exclusion Criteria
Description

Exclusion Criteria

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

hypersensitivity to trial product or related products

Data type

boolean

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

participation status

Data type

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
Description

APL

Data type

boolean

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

eligibility for allogeneic haematopoietic transplantation

Data type

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)
Description

concurrent other investigational therapy

Data type

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
Description

g-csf treatment time

Data type

boolean

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

steroids time

Data type

boolean

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

autoimmune disease

Data type

boolean

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

monoclonal gammopathy

Data type

boolean

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

active infection

Data type

boolean

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

cns leukemia

Data type

boolean

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

cardiac failure

Data type

boolean

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

LVEF

Data type

boolean

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

comorbidity

Data type

boolean

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

hiv or chronic hepatitis

Data type

boolean

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

second malignancy

Data type

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
Description

comprehension problems limiting study protocol

Data type

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
Description

comorbidity limiting study protocol

Data type

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 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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