ID

35839

Descrição

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL); ODM derived from: https://clinicaltrials.gov/show/NCT02391116

Link

https://clinicaltrials.gov/show/NCT02391116

Palavras-chave

Versões (1)
  1. 26/03/2019 26/03/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

26 de março de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Diffuse Large-Cell Lymphoma NCT02391116

Inglês

Eligibility Diffuse Large-Cell Lymphoma NCT02391116

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of diffuse large b-cell lymphoma (dlbcl) (de novo or dlbcl transformed from follicular lymphoma on the basis of a tissue biopsy).
Descrição

Diffuse Large B-Cell Lymphoma de novo | Diffuse Large B-Cell Lymphoma Transformation Follicular Lymphoma | Biopsy tissue

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1515568
UMLS CUI [2,1]
C0079744
UMLS CUI [2,2]
C0040682
UMLS CUI [2,3]
C0024301
UMLS CUI [3]
C3864006
received at least one prior therapy for aggressive non-hodgkin's lymphoma (nhl) (dlbcl)
Descrição

Prior Therapy Quantity Aggressive Non-Hodgkin Lymphoma | Prior Therapy Quantity Diffuse Large B-Cell Lymphoma Aggressive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1332225
UMLS CUI [2,1]
C1514463
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0079744
UMLS CUI [2,4]
C0580822
patients must have measurable disease.
Descrição

Measurable Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1513041
ecog (eastern cooperative oncology group) performance status (ps) ≤ 2
Descrição

ECOG performance status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1520224
left ventricular ejection fraction (lvef) ≥ the lower limit of normal (lln) for the institution (as per local standard of care) as measured by echocardiogram (echo) or multiple gated acquisition (muga) scan
Descrição

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
adequate bone marrow, liver and renal function.
Descrição

Bone Marrow function | Liver function | Renal function

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
Descrição

Site Only Disease | Lymph node palpable Invisible Imaging studies | Skin lesion | Bone Marrow Involvement

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0205171
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1112395
UMLS CUI [2,2]
C0205398
UMLS CUI [2,3]
C1881134
UMLS CUI [3]
C0037284
UMLS CUI [4]
C1517677
active ctcae (common terminology criteria for adverse events) grade 3/4 infection
Descrição

Communicable Disease CTCAE Grades

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C1516728
known history of human immunodeficiency virus (hiv) infection
Descrição

HIV Infection

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019693
current central nervous system (cns) involvement by lymphoma
Descrição

Central Nervous System Involvement Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C4050309
UMLS CUI [1,2]
C0024299
unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). myocardial infarction within the past 6 months before start of study treatment
Descrição

Angina, Unstable | Angina Pectoris New onset | Myocardial Infarction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0746890
UMLS CUI [3]
C0027051
type i or ii diabetes mellitus with hba1c > 8.5% or fasting plasma glucose > 160 mg/dl at screening.
Descrição

Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Plasma fasting glucose measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0011854
UMLS CUI [2]
C0011860
UMLS CUI [3]
C0474680
UMLS CUI [4]
C0583513
new york heart association (nyha) class iii or iv heart disease
Descrição

Heart Disease New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018799
UMLS CUI [1,2]
C1275491
concurrent participation in other clinical studies.
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
patients who previously received therapy with copanlisib or other pi3k inhibitors are not eligible for enrollment.
Descrição

copanlisib | Phosphatidylinositide 3-Kinase Inhibitor

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4049141
UMLS CUI [2]
C1519050
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Similar models

Eligibility Diffuse Large-Cell Lymphoma NCT02391116

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Diffuse Large B-Cell Lymphoma de novo | Diffuse Large B-Cell Lymphoma Transformation Follicular Lymphoma | Biopsy tissue
Item
diagnosis of diffuse large b-cell lymphoma (dlbcl) (de novo or dlbcl transformed from follicular lymphoma on the basis of a tissue biopsy).
boolean
C0079744 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0079744 (UMLS CUI [2,1])
C0040682 (UMLS CUI [2,2])
C0024301 (UMLS CUI [2,3])
C3864006 (UMLS CUI [3])
Prior Therapy Quantity Aggressive Non-Hodgkin Lymphoma | Prior Therapy Quantity Diffuse Large B-Cell Lymphoma Aggressive
Item
received at least one prior therapy for aggressive non-hodgkin's lymphoma (nhl) (dlbcl)
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1332225 (UMLS CUI [1,3])
C1514463 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0079744 (UMLS CUI [2,3])
C0580822 (UMLS CUI [2,4])
Measurable Disease
Item
patients must have measurable disease.
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
ecog (eastern cooperative oncology group) performance status (ps) ≤ 2
boolean
C1520224 (UMLS CUI [1])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
left ventricular ejection fraction (lvef) ≥ the lower limit of normal (lln) for the institution (as per local standard of care) as measured by echocardiogram (echo) or multiple gated acquisition (muga) scan
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Bone Marrow function | Liver function | Renal function
Item
adequate bone marrow, liver and renal function.
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Site Only Disease | Lymph node palpable Invisible Imaging studies | Skin lesion | Bone Marrow Involvement
Item
any of the following as the only site(s) of disease: palpable lymph nodes not visible on imaging studies, skin lesions, or bone marrow involvement only
boolean
C1515974 (UMLS CUI [1,1])
C0205171 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1112395 (UMLS CUI [2,1])
C0205398 (UMLS CUI [2,2])
C1881134 (UMLS CUI [2,3])
C0037284 (UMLS CUI [3])
C1517677 (UMLS CUI [4])
Communicable Disease CTCAE Grades
Item
active ctcae (common terminology criteria for adverse events) grade 3/4 infection
boolean
C0009450 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
HIV Infection
Item
known history of human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Central Nervous System Involvement Lymphoma
Item
current central nervous system (cns) involvement by lymphoma
boolean
C4050309 (UMLS CUI [1,1])
C0024299 (UMLS CUI [1,2])
Angina, Unstable | Angina Pectoris New onset | Myocardial Infarction
Item
unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months). myocardial infarction within the past 6 months before start of study treatment
boolean
C0002965 (UMLS CUI [1])
C0002962 (UMLS CUI [2,1])
C0746890 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
Diabetes Mellitus, Insulin-Dependent | Diabetes Mellitus, Non-Insulin-Dependent | Hemoglobin A1c measurement | Plasma fasting glucose measurement
Item
type i or ii diabetes mellitus with hba1c > 8.5% or fasting plasma glucose > 160 mg/dl at screening.
boolean
C0011854 (UMLS CUI [1])
C0011860 (UMLS CUI [2])
C0474680 (UMLS CUI [3])
C0583513 (UMLS CUI [4])
Heart Disease New York Heart Association Classification
Item
new york heart association (nyha) class iii or iv heart disease
boolean
C0018799 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Study Subject Participation Status
Item
concurrent participation in other clinical studies.
boolean
C2348568 (UMLS CUI [1])
copanlisib | Phosphatidylinositide 3-Kinase Inhibitor
Item
patients who previously received therapy with copanlisib or other pi3k inhibitors are not eligible for enrollment.
boolean
C4049141 (UMLS CUI [1])
C1519050 (UMLS CUI [2])
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