ID

38489

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01300026

Palabras clave

Versiones (1)
  1. 22/10/19 22/10/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

22 de octubre de 2019

DOI

Para solicitar uno, por favor iniciar sesión.

Licencia

Creative Commons BY 4.0
Comentarios del modelo :

Puede comentar sobre el modelo de datos aquí. A través de las burbujas de diálogo en los grupos de elementos y elementos, puede agregar comentarios específicos.

Volver a los comentarios del modelo
Comentarios de grupo de elementos para :

Comentarios del elemento para :

Para descargar modelos de datos, debe haber iniciado sesión. Por favor iniciar sesión o Registrate gratis.

Eligibility Cancer NCT01300026

Inglés

Eligibility Cancer NCT01300026

1 formularios  
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01300026
Inclusion Criteria
Descripción

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:
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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.
Descripción

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

Tipo de datos

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
Descripción

ECOG performance status

Tipo de datos

boolean

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

Life Expectancy

Tipo de datos

boolean

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

Age

Tipo de datos

boolean

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

Hematologic function

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Exclusion Criteria

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

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

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

Allogeneic Stem Cell Transplantation | Organ Transplantation

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

QTcF - Fridericia's Correction Formula

Tipo de datos

boolean

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

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

Tipo de datos

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 ≤
Descripción

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

Tipo de datos

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
Descripción

ID.17

Tipo de datos

boolean

Volver a la parte superior de la página

Similar models

Eligibility Cancer NCT01300026

1 formularios
  1. StudyEvent: Eligibility
    1. Eligibility Cancer NCT01300026
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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
Volver a la parte superior de la página 

Contacto

Utilice este formulario para comentarios, preguntas y sugerencias.

Los campos marcados con * son obligatorios.

Ayuda

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial