ID

38489

Beskrivning

AMG 319 Lymphoid Malignancy FIH; ODM derived from: https://clinicaltrials.gov/show/NCT01300026

Länk

https://clinicaltrials.gov/show/NCT01300026

Nyckelord

Versioner (1)
  1. 2019-10-22 2019-10-22 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

22 oktober 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cancer NCT01300026

Engelsk

Eligibility Cancer NCT01300026

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01300026
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
part 1 (dose exploration): relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:
Beskrivning

Malignant lymphoid neoplasm Relapse | Malignant lymphoid neoplasm refractory | Standard of Care Unavailable | Standard of Care ineffective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0746336
UMLS CUI [1,2]
C0035020
UMLS CUI [2,1]
C0746336
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C3242229
b-cell chronic lymphocytic leukemia (cll) confirmed by immunophenotype or non-hodgkin lymphoma: low or intermediate grade b-cell nhl, mantle cell lymphoma, non-cutaneous t-cell nhl confirmed by histology and/or immunophenotype
Beskrivning

Chronic Lymphocytic Leukemia Immunophenotyping | Lymphoma, Non-Hodgkin | B-Cell Lymphoma low grade | B-Cell Lymphoma Intermediate Grade | Mantle cell lymphoma | T-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0023434
UMLS CUI [1,2]
C0079611
UMLS CUI [2]
C0024305
UMLS CUI [3,1]
C0079731
UMLS CUI [3,2]
C1282907
UMLS CUI [4,1]
C0079731
UMLS CUI [4,2]
C1512863
UMLS CUI [5]
C0334634
UMLS CUI [6]
C0079772
part 2 (dose expansion): subjects must have relapsed or refractory b-cell chronic lymphocytic leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
Beskrivning

Recurrent Chronic Lymphoid Leukemia Immunophenotyping | Chronic lymphocytic leukaemia refractory Immunophenotyping | Standard of Care Unavailable | Standard of Care ineffective

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0854802
UMLS CUI [1,2]
C0079611
UMLS CUI [2,1]
C0278791
UMLS CUI [2,2]
C0079611
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C0686905
UMLS CUI [4,1]
C2936643
UMLS CUI [4,2]
C3242229
eastern cooperative oncology group (ecog) performance status ≤ 2
Beskrivning

ECOG performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
life expectancy of > 3 months, in the opinion of the investigator
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
men or women ≥ 18 years old
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
hematological function, as follows:
Beskrivning

Hematologic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0221130
absolute neutrophil count (anc) ≥ 1.5 x 109/l (unless due to disease-related bone marrow involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/l) platelet count ≥ 50 x 109/l (without a transfusion within 14 days before enrollment) hemoglobin ≥ 9 g/dl
Beskrivning

Absolute neutrophil count | Exception Bone Marrow Involvement | Platelet Count measurement | Transfusion Absent | Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0948762
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1517677
UMLS CUI [3]
C0032181
UMLS CUI [4,1]
C1879316
UMLS CUI [4,2]
C0332197
UMLS CUI [5]
C0518015
hepatic function, as follows: aspartate aminotransferase (ast) < 3.0 x uln alanine aminotransferase (alt) < 3.0 x uln alkaline phosphatase (alp) < 2.0 x uln (< 5 x uln in subjects whom the pi and sponsor agree that clinical data suggest an extrahepatic source of elevation) total bilirubin < 1.5 x uln (< 3.0 x uln for subjects with documented gilbert's disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation) amylase ≤ 2.0 x iuln lipase ≤ 2.0 x iuln
Beskrivning

Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Etiology Extrahepatic | Serum total bilirubin measurement | Gilbert Disease | Serum indirect bilirubin measurement | Amylase measurement | Lipase measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0232741
UMLS CUI [2]
C0201899
UMLS CUI [3]
C0201836
UMLS CUI [4]
C0201850
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C1517058
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0017551
UMLS CUI [8]
C2229600
UMLS CUI [9]
C0201883
UMLS CUI [10]
C0373670
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
primary or disseminated tumor involving the central nervous system (cns)
Beskrivning

Primary tumor Central Nervous System Involvement | Disseminated Malignant Neoplasm Central Nervous System Involvement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0677930
UMLS CUI [1,2]
C4050309
UMLS CUI [2,1]
C0346957
UMLS CUI [2,2]
C4050309
a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
Beskrivning

Cancer Other | Exception Skin carcinoma Treated | Exception Curative treatment In situ cancer | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C1707251
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [2,3]
C1522326
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0851135
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0280100
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0012634
UMLS CUI [5,3]
C0332296
UMLS CUI [5,4]
C0449238
history of allogeneic stem-cell (or other organ) transplantation
Beskrivning

Allogeneic Stem Cell Transplantation | Organ Transplantation

Datatyp

boolean

Alias
UMLS CUI [1]
C2242529
UMLS CUI [2]
C0029216
clinically significant ecg changes which obscure the ability to assess the pr, qt, and qrs interval; congenital long qt syndrome
Beskrivning

Electrocardiographic changes Interfere with P-R interval | Electrocardiographic changes Interfere with QT interval | Electrocardiographic changes Interfere with QRS interval | Congenital long QT syndrome

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0855329
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0429087
UMLS CUI [2,1]
C0855329
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0429028
UMLS CUI [3,1]
C0855329
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2168881
UMLS CUI [4]
C1141890
qtcf interval > 470 msec
Beskrivning

QTcF - Fridericia's Correction Formula

Datatyp

boolean

Alias
UMLS CUI [1]
C1882513
active or chronic hepatitis b or hepatitis c infection, determined by serologic tests
Beskrivning

Hepatitis B Serologic tests | Chronic Hepatitis B Serologic tests | Hepatitis C Serologic tests | Chronic Hepatitis C Serologic tests

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0036743
UMLS CUI [2,1]
C0524909
UMLS CUI [2,2]
C0036743
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0036743
UMLS CUI [4,1]
C0524910
UMLS CUI [4,2]
C0036743
recent infection requiring intravenous anti-infective treatment that was completed ≤
Beskrivning

Communicable Disease Recent | Requirement Anti-infective therapy Intravenous | Anti-infective therapy Completed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C1141958
UMLS CUI [2,3]
C1522726
UMLS CUI [3,1]
C1141958
UMLS CUI [3,2]
C0205197
14 days before enrollment
Beskrivning

ID.17

Datatyp

boolean

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Similar models

Eligibility Cancer NCT01300026

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01300026
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Malignant lymphoid neoplasm Relapse | Malignant lymphoid neoplasm refractory | Standard of Care Unavailable | Standard of Care ineffective
Item
part 1 (dose exploration): relapsed or refractory lymphoid malignancy of the following type for which standard treatment does not exist or is no longer effective:
boolean
C0746336 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0746336 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
Chronic Lymphocytic Leukemia Immunophenotyping | Lymphoma, Non-Hodgkin | B-Cell Lymphoma low grade | B-Cell Lymphoma Intermediate Grade | Mantle cell lymphoma | T-Cell Lymphoma
Item
b-cell chronic lymphocytic leukemia (cll) confirmed by immunophenotype or non-hodgkin lymphoma: low or intermediate grade b-cell nhl, mantle cell lymphoma, non-cutaneous t-cell nhl confirmed by histology and/or immunophenotype
boolean
C0023434 (UMLS CUI [1,1])
C0079611 (UMLS CUI [1,2])
C0024305 (UMLS CUI [2])
C0079731 (UMLS CUI [3,1])
C1282907 (UMLS CUI [3,2])
C0079731 (UMLS CUI [4,1])
C1512863 (UMLS CUI [4,2])
C0334634 (UMLS CUI [5])
C0079772 (UMLS CUI [6])
Recurrent Chronic Lymphoid Leukemia Immunophenotyping | Chronic lymphocytic leukaemia refractory Immunophenotyping | Standard of Care Unavailable | Standard of Care ineffective
Item
part 2 (dose expansion): subjects must have relapsed or refractory b-cell chronic lymphocytic leukemia confirmed by immunophenotype for which standard treatment does not exist or is no longer effective.
boolean
C0854802 (UMLS CUI [1,1])
C0079611 (UMLS CUI [1,2])
C0278791 (UMLS CUI [2,1])
C0079611 (UMLS CUI [2,2])
C2936643 (UMLS CUI [3,1])
C0686905 (UMLS CUI [3,2])
C2936643 (UMLS CUI [4,1])
C3242229 (UMLS CUI [4,2])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of > 3 months, in the opinion of the investigator
boolean
C0023671 (UMLS CUI [1])
Age
Item
men or women ≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Hematologic function
Item
hematological function, as follows:
boolean
C0221130 (UMLS CUI [1])
Absolute neutrophil count | Exception Bone Marrow Involvement | Platelet Count measurement | Transfusion Absent | Hemoglobin measurement
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l (unless due to disease-related bone marrow involvement as documented by bone marrow biopsy, ≥ 0.5 x 109/l) platelet count ≥ 50 x 109/l (without a transfusion within 14 days before enrollment) hemoglobin ≥ 9 g/dl
boolean
C0948762 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1517677 (UMLS CUI [2,2])
C0032181 (UMLS CUI [3])
C1879316 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0518015 (UMLS CUI [5])
Liver function | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Alkaline phosphatase measurement | Etiology Extrahepatic | Serum total bilirubin measurement | Gilbert Disease | Serum indirect bilirubin measurement | Amylase measurement | Lipase measurement
Item
hepatic function, as follows: aspartate aminotransferase (ast) < 3.0 x uln alanine aminotransferase (alt) < 3.0 x uln alkaline phosphatase (alp) < 2.0 x uln (< 5 x uln in subjects whom the pi and sponsor agree that clinical data suggest an extrahepatic source of elevation) total bilirubin < 1.5 x uln (< 3.0 x uln for subjects with documented gilbert's disease or for whom the indirect bilirubin level suggests an extrahepatic source of elevation) amylase ≤ 2.0 x iuln lipase ≤ 2.0 x iuln
boolean
C0232741 (UMLS CUI [1])
C0201899 (UMLS CUI [2])
C0201836 (UMLS CUI [3])
C0201850 (UMLS CUI [4])
C0015127 (UMLS CUI [5,1])
C1517058 (UMLS CUI [5,2])
C1278039 (UMLS CUI [6])
C0017551 (UMLS CUI [7])
C2229600 (UMLS CUI [8])
C0201883 (UMLS CUI [9])
C0373670 (UMLS CUI [10])
Item Group
C0680251 (UMLS CUI)
Primary tumor Central Nervous System Involvement | Disseminated Malignant Neoplasm Central Nervous System Involvement
Item
primary or disseminated tumor involving the central nervous system (cns)
boolean
C0677930 (UMLS CUI [1,1])
C4050309 (UMLS CUI [1,2])
C0346957 (UMLS CUI [2,1])
C4050309 (UMLS CUI [2,2])
Cancer Other | Exception Skin carcinoma Treated | Exception Curative treatment In situ cancer | Exception Curative treatment Solid Neoplasm | Exception Disease Free Duration
Item
a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for ≥ 2 years
boolean
C1707251 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0851135 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0280100 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Allogeneic Stem Cell Transplantation | Organ Transplantation
Item
history of allogeneic stem-cell (or other organ) transplantation
boolean
C2242529 (UMLS CUI [1])
C0029216 (UMLS CUI [2])
Electrocardiographic changes Interfere with P-R interval | Electrocardiographic changes Interfere with QT interval | Electrocardiographic changes Interfere with QRS interval | Congenital long QT syndrome
Item
clinically significant ecg changes which obscure the ability to assess the pr, qt, and qrs interval; congenital long qt syndrome
boolean
C0855329 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0429087 (UMLS CUI [1,3])
C0855329 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0429028 (UMLS CUI [2,3])
C0855329 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2168881 (UMLS CUI [3,3])
C1141890 (UMLS CUI [4])
QTcF - Fridericia's Correction Formula
Item
qtcf interval > 470 msec
boolean
C1882513 (UMLS CUI [1])
Hepatitis B Serologic tests | Chronic Hepatitis B Serologic tests | Hepatitis C Serologic tests | Chronic Hepatitis C Serologic tests
Item
active or chronic hepatitis b or hepatitis c infection, determined by serologic tests
boolean
C0019163 (UMLS CUI [1,1])
C0036743 (UMLS CUI [1,2])
C0524909 (UMLS CUI [2,1])
C0036743 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0036743 (UMLS CUI [3,2])
C0524910 (UMLS CUI [4,1])
C0036743 (UMLS CUI [4,2])
Communicable Disease Recent | Requirement Anti-infective therapy Intravenous | Anti-infective therapy Completed
Item
recent infection requiring intravenous anti-infective treatment that was completed ≤
boolean
C0009450 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C1141958 (UMLS CUI [2,2])
C1522726 (UMLS CUI [2,3])
C1141958 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
ID.17
Item
14 days before enrollment
boolean
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