ID

38489

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01300026

Trefwoorden

Versies (1)
  1. 22-10-19 22-10-19 -
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22 oktober 2019

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    Eligibility Cancer NCT01300026

    Engels

    Eligibility Cancer NCT01300026

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Cancer NCT01300026
    Inclusion Criteria
    Beschrijving

    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:
    Beschrijving

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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.
    Beschrijving

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

    Datatype

    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
    Beschrijving

    ECOG performance status

    Datatype

    boolean

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

    Life Expectancy

    Datatype

    boolean

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

    Age

    Datatype

    boolean

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

    Hematologic function

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    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

    Datatype

    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
    Beschrijving

    Exclusion Criteria

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

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

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    Allogeneic Stem Cell Transplantation | Organ Transplantation

    Datatype

    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
    Beschrijving

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

    Datatype

    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
    Beschrijving

    QTcF - Fridericia's Correction Formula

    Datatype

    boolean

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

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

    Datatype

    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 ≤
    Beschrijving

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

    Datatype

    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
    Beschrijving

    ID.17

    Datatype

    boolean

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    Similar models

    Eligibility Cancer NCT01300026

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Cancer NCT01300026
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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