ID

18017

Descrição

Study of HuMax-CD20, a New Drug to Treat Early Stage Non-Hodgkin´s Follicular Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00092274

Link

https://clinicaltrials.gov/show/NCT00092274

Palavras-chave

Versões (1)
  1. 14/10/2016 14/10/2016 -
Transferido a

14 de outubro de 2016

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Lymphoma, Follicular NCT00092274

Inglês

Eligibility Lymphoma, Follicular NCT00092274

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
relapsed or refractory follicular lymphoma grade i-ii
Descrição

recurrent grade 1 follicular lymphoma | recurrent grade 2 follicular lymphoma | Refractory Follicular Lymphoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0280182
UMLS CUI [2]
C0280183
UMLS CUI [3]
C1335723
tumor verified to be cd20 positive
Descrição

Neoplasm CD20 antigen positive

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3888518
ct scan showing demarcated lesions
Descrição

demarcated lesion | X-Ray Computed Tomography

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2168704
UMLS CUI [2]
C0040405
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with rituximab resulting in less than partial response
Descrição

rituximab Resulting in Partial response Less Than

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0393022
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C1521726
UMLS CUI [1,4]
C0439092
previous radioimmunotherapy
Descrição

Radioimmunotherapy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0085101
previous stem cell transplantation
Descrição

Stem cell transplant

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1504389
received the following treatments within 4 weeks prior to entering this study:
Descrição

Therapeutic procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0087111
1. anti-cancer therapy
Descrição

cancer treatment

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0920425
2. glucocorticosteroids unless less than 10 mg prednisolone/day
Descrição

Glucocorticoids | prednisolone U/day

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0017710
UMLS CUI [2,1]
C0032950
UMLS CUI [2,2]
C0456683
3. radiotherapy
Descrição

Therapeutic radiology procedure

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1522449
received mitomycin c or nitrosoureas within 6 weeks prior to entering this trial
Descrição

Mitomycin | Nitrosourea

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0002475
UMLS CUI [2]
C0028210
hiv positivity
Descrição

HIV Seropositivity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019699
hepatitis b or hepatitis c
Descrição

Hepatitis B | Hepatitis C

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
uncontrolled or chronic bacterial, fungal or viral infection
Descrição

Bacterial Infections Uncontrolled | Mycoses Uncontrolled | Virus Diseases Uncontrolled | Bacterial Infections chronic | Mycoses chronic | Virus Diseases chronic

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004623
UMLS CUI [1,2]
C0205318
UMLS CUI [2,1]
C0026946
UMLS CUI [2,2]
C0205318
UMLS CUI [3,1]
C0042769
UMLS CUI [3,2]
C0205318
UMLS CUI [4,1]
C0004623
UMLS CUI [4,2]
C0205191
UMLS CUI [5,1]
C0026946
UMLS CUI [5,2]
C0205191
UMLS CUI [6,1]
C0042769
UMLS CUI [6,2]
C0205191
other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
Descrição

Malignant Neoplasms | Skin carcinoma | Cervix carcinoma | Breast Carcinoma

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2]
C0699893
UMLS CUI [3]
C0302592
UMLS CUI [4]
C0678222
certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
Descrição

medical condition Serious | Kidney Diseases | Liver diseases | Mental disorders | Stomach Diseases | Lung diseases | Heart Diseases | Endocrine System Diseases | nervous system disorder | Hematological Disease

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0022658
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0004936
UMLS CUI [5]
C0038354
UMLS CUI [6]
C0024115
UMLS CUI [7]
C0018799
UMLS CUI [8]
C0014130
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0018939
who performance status of 3 or 4
Descrição

WHO performance status scale

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1298650
if you are participating in another trial with a different new drug 4 weeks before you enter this trial
Descrição

Study Subject Participation Status | Investigational New Drugs

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
current participation in any other clinical study
Descrição

Study Subject Participation Status

Tipo de dados

boolean

Alias
UMLS CUI [1]
C2348568
pregnant or breast-feeding women
Descrição

Pregnancy | Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
women of childbearing age who are unable or unwilling to use an iud or hormonal birth control during the whole trial
Descrição

Childbearing Potential Intrauterine Device Unwilling | Childbearing Potential Hormonal contraception Unwilling

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0021900
UMLS CUI [1,3]
C0558080
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C2985296
UMLS CUI [2,3]
C0558080
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Similar models

Eligibility Lymphoma, Follicular NCT00092274

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
recurrent grade 1 follicular lymphoma | recurrent grade 2 follicular lymphoma | Refractory Follicular Lymphoma
Item
relapsed or refractory follicular lymphoma grade i-ii
boolean
C0280182 (UMLS CUI [1])
C0280183 (UMLS CUI [2])
C1335723 (UMLS CUI [3])
Neoplasm CD20 antigen positive
Item
tumor verified to be cd20 positive
boolean
C0027651 (UMLS CUI [1,1])
C3888518 (UMLS CUI [1,2])
demarcated lesion | X-Ray Computed Tomography
Item
ct scan showing demarcated lesions
boolean
C2168704 (UMLS CUI [1])
C0040405 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
rituximab Resulting in Partial response Less Than
Item
previous treatment with rituximab resulting in less than partial response
boolean
C0393022 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C1521726 (UMLS CUI [1,3])
C0439092 (UMLS CUI [1,4])
Radioimmunotherapy
Item
previous radioimmunotherapy
boolean
C0085101 (UMLS CUI [1])
Stem cell transplant
Item
previous stem cell transplantation
boolean
C1504389 (UMLS CUI [1])
Therapeutic procedure
Item
received the following treatments within 4 weeks prior to entering this study:
boolean
C0087111 (UMLS CUI [1])
cancer treatment
Item
1. anti-cancer therapy
boolean
C0920425 (UMLS CUI [1])
Glucocorticoids | prednisolone U/day
Item
2. glucocorticosteroids unless less than 10 mg prednisolone/day
boolean
C0017710 (UMLS CUI [1])
C0032950 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
Therapeutic radiology procedure
Item
3. radiotherapy
boolean
C1522449 (UMLS CUI [1])
Mitomycin | Nitrosourea
Item
received mitomycin c or nitrosoureas within 6 weeks prior to entering this trial
boolean
C0002475 (UMLS CUI [1])
C0028210 (UMLS CUI [2])
HIV Seropositivity
Item
hiv positivity
boolean
C0019699 (UMLS CUI [1])
Hepatitis B | Hepatitis C
Item
hepatitis b or hepatitis c
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
Bacterial Infections Uncontrolled | Mycoses Uncontrolled | Virus Diseases Uncontrolled | Bacterial Infections chronic | Mycoses chronic | Virus Diseases chronic
Item
uncontrolled or chronic bacterial, fungal or viral infection
boolean
C0004623 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0026946 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0042769 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0004623 (UMLS CUI [4,1])
C0205191 (UMLS CUI [4,2])
C0026946 (UMLS CUI [5,1])
C0205191 (UMLS CUI [5,2])
C0042769 (UMLS CUI [6,1])
C0205191 (UMLS CUI [6,2])
Malignant Neoplasms | Skin carcinoma | Cervix carcinoma | Breast Carcinoma
Item
other cancer diseases, except certain skin cancers, cervix cancer and breast cancer
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0302592 (UMLS CUI [3])
C0678222 (UMLS CUI [4])
medical condition Serious | Kidney Diseases | Liver diseases | Mental disorders | Stomach Diseases | Lung diseases | Heart Diseases | Endocrine System Diseases | nervous system disorder | Hematological Disease
Item
certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases
boolean
C3843040 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0004936 (UMLS CUI [4])
C0038354 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0018799 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0018939 (UMLS CUI [10])
WHO performance status scale
Item
who performance status of 3 or 4
boolean
C1298650 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs
Item
if you are participating in another trial with a different new drug 4 weeks before you enter this trial
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Study Subject Participation Status
Item
current participation in any other clinical study
boolean
C2348568 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Childbearing Potential Intrauterine Device Unwilling | Childbearing Potential Hormonal contraception Unwilling
Item
women of childbearing age who are unable or unwilling to use an iud or hormonal birth control during the whole trial
boolean
C3831118 (UMLS CUI [1,1])
C0021900 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C2985296 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
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