ID

35832

Descripción

Study of Selinexor (KPT-330) in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (SADAL); ODM derived from: https://clinicaltrials.gov/show/NCT02227251

Link

https://clinicaltrials.gov/show/NCT02227251

Palabras clave

  1. 26/3/19 26/3/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

26 de marzo de 2019

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility Diffuse Large B-cell Lymphoma NCT02227251

Eligibility Diffuse Large B-cell Lymphoma NCT02227251

Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
age ≥18 years
Descripción

Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
eastern cooperative oncology group (ecog) performance status of ≤ 2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
pathologically confirmed de novo dlbcl
Descripción

Diffuse Large B-Cell Lymphoma de novo

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0079744
UMLS CUI [1,2]
C1515568
objective, documented evidence of disease progression on study entry
Descripción

Disease Progression

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0242656
have previously received at least 2 but no more than 4 previous systemic multi-agent regimens for the treatment of dlbcl
Descripción

Chemotherapy multiple agents systemic Quantity Diffuse Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0854615
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C0079744
have measurable disease
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
dlbcl with coexistent histologies
Descripción

Diffuse Large B-Cell Lymphoma | Histology Other

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079744
UMLS CUI [2,1]
C0344441
UMLS CUI [2,2]
C0205394
must not be eligible for high-dose therapy with autologous stem cell transplantation rescue
Descripción

Therapy High dose Autologous Stem Cell Rescue

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0444956
UMLS CUI [1,3]
C2825926
primary mediastinal (thymic) large b-cell lymphoma (pmbl)
Descripción

Mediastinal (Thymic) Large B-Cell Lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1292754
known central nervous system (cns) lymphoma
Descripción

Central nervous system lymphoma

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0742472
active hepatitis b or c infection
Descripción

Hepatitis B | Hepatitis C

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
known human immunodeficiency virus (hiv) infection
Descripción

HIV Infection

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0019693
unable to swallow tablets, patients with malabsorption syndrome, or any other gi disease or gi function that could interfere with absorption of study treatment
Descripción

Lacking Able to swallow Tablets | Malabsorption Syndrome | Gastrointestinal Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal function Interferes with Absorption Investigational New Drugs

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
UMLS CUI [2]
C0024523
UMLS CUI [3,1]
C0017178
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0237442
UMLS CUI [3,4]
C0013230
UMLS CUI [4,1]
C0516983
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0237442
UMLS CUI [4,4]
C0013230

Similar models

Eligibility Diffuse Large B-cell Lymphoma NCT02227251

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age ≥18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status of ≤ 2
boolean
C1520224 (UMLS CUI [1])
Diffuse Large B-Cell Lymphoma de novo
Item
pathologically confirmed de novo dlbcl
boolean
C0079744 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Disease Progression
Item
objective, documented evidence of disease progression on study entry
boolean
C0242656 (UMLS CUI [1])
Chemotherapy multiple agents systemic Quantity Diffuse Large B-Cell Lymphoma
Item
have previously received at least 2 but no more than 4 previous systemic multi-agent regimens for the treatment of dlbcl
boolean
C0854615 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0079744 (UMLS CUI [1,3])
Measurable Disease
Item
have measurable disease
boolean
C1513041 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diffuse Large B-Cell Lymphoma | Histology Other
Item
dlbcl with coexistent histologies
boolean
C0079744 (UMLS CUI [1])
C0344441 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
Therapy High dose Autologous Stem Cell Rescue
Item
must not be eligible for high-dose therapy with autologous stem cell transplantation rescue
boolean
C0087111 (UMLS CUI [1,1])
C0444956 (UMLS CUI [1,2])
C2825926 (UMLS CUI [1,3])
Mediastinal (Thymic) Large B-Cell Lymphoma
Item
primary mediastinal (thymic) large b-cell lymphoma (pmbl)
boolean
C1292754 (UMLS CUI [1])
Central nervous system lymphoma
Item
known central nervous system (cns) lymphoma
boolean
C0742472 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
active hepatitis b or c infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
HIV Infection
Item
known human immunodeficiency virus (hiv) infection
boolean
C0019693 (UMLS CUI [1])
Lacking Able to swallow Tablets | Malabsorption Syndrome | Gastrointestinal Disease Interferes with Absorption Investigational New Drugs | Gastrointestinal function Interferes with Absorption Investigational New Drugs
Item
unable to swallow tablets, patients with malabsorption syndrome, or any other gi disease or gi function that could interfere with absorption of study treatment
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
C0024523 (UMLS CUI [2])
C0017178 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0237442 (UMLS CUI [3,3])
C0013230 (UMLS CUI [3,4])
C0516983 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0237442 (UMLS CUI [4,3])
C0013230 (UMLS CUI [4,4])

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