0 Avaliações
ID

37684

Descrição

Lenalidomide, MTX, Ara-C and Rituximab in Relapsed Aggressive B-cell Lymphomas; ODM derived from: https://clinicaltrials.gov/show/NCT01788189

Link

https://clinicaltrials.gov/show/NCT01788189

Palavras-chave

Versões (2)
  1. 16/08/2019 16/08/2019 -
  2. 16/08/2019 16/08/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

16 de agosto de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility B-cell Lymphoma NCT01788189

    Inglês

    Eligibility B-cell Lymphoma NCT01788189

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    age ≥ 18 years
    Descrição

    Age

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    performance status ecog 0 - 3
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
    Descrição

    Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0677726
    UMLS CUI [1,2]
    C0004561
    UMLS CUI [1,3]
    C3888518
    UMLS CUI [2,1]
    C0854870
    UMLS CUI [2,2]
    C0004561
    UMLS CUI [2,3]
    C3888518
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0334634
    measurable disease
    Descrição

    Measurable Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
    Descrição

    Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1512714
    UMLS CUI [1,2]
    C1512429
    UMLS CUI [2,1]
    C1512429
    UMLS CUI [2,2]
    C0558080
    ability to understand the aim of the study and act accordingly
    Descrição

    Comprehension Study Protocol | Protocol Compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0162340
    UMLS CUI [1,2]
    C2348563
    UMLS CUI [2]
    C0525058
    effective contraception
    Descrição

    Contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    signed informed consent
    Descrição

    Informed Consent

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    central nervous system relapse of aggressive lymphoma
    Descrição

    Central nervous system lymphoma Aggressive Relapse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0280803
    UMLS CUI [1,2]
    C0580822
    UMLS CUI [1,3]
    C0205336
    any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    Descrição

    Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C0332196
    UMLS CUI [2,1]
    C0438215
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C0332196
    UMLS CUI [3,1]
    C0004936
    UMLS CUI [3,2]
    C2348568
    UMLS CUI [3,3]
    C0332196
    any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
    Descrição

    Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [2,1]
    C0438215
    UMLS CUI [2,2]
    C2348568
    UMLS CUI [2,3]
    C1444641
    any condition that confounds the ability to interpret data from the study
    Descrição

    Condition Interferes with Interpretation Research data

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0459471
    UMLS CUI [1,4]
    C0681873
    inadequate organ function not related to aggressive lymphoma:
    Descrição

    Organ function Inadequate | Relationship Absent Aggressive Lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0678852
    UMLS CUI [1,2]
    C0205412
    UMLS CUI [2,1]
    C0439849
    UMLS CUI [2,2]
    C0332197
    UMLS CUI [2,3]
    C1332225
    neutrophils < 1.0/nl
    Descrição

    Neutrophil count

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0200633
    platelets < 75/nl
    Descrição

    Platelet Count measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    creatinine clearance < 60 ml/min
    Descrição

    Creatinine clearance measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    bilirubin ≥ 2,5 mg/dl
    Descrição

    Bilirubin measurement

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0344395
    serum ast/got or alt/gpt ≥ 4 x upper limit of normal
    Descrição

    Aspartate aminotransferase increased | Alanine aminotransferase increased

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0151904
    UMLS CUI [2]
    C0151905
    active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
    Descrição

    Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0042721
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    UMLS CUI [4]
    C0019693
    UMLS CUI [5,1]
    C0009450
    UMLS CUI [5,2]
    C0205318
    pregnancy and nursing period
    Descrição

    Pregnancy | Breast Feeding

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
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    Similar models

    Eligibility B-cell Lymphoma NCT01788189

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    age ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    performance status ecog 0 - 3
    boolean
    C1520224 (UMLS CUI [1])
    Recurrent Aggressive Adult Non-Hodgkin Lymphoma B-Cell CD20 positive | Non-Hodgkin's lymphoma aggressive refractory B-Cell CD20 positive | Exception Mantle cell lymphoma
    Item
    first or subsequent relapse or refractoriness of a biopsy-proven cd20-positive aggressive b cell lymphoma (excluding mantle cell lymphoma)
    boolean
    C0677726 (UMLS CUI [1,1])
    C0004561 (UMLS CUI [1,2])
    C3888518 (UMLS CUI [1,3])
    C0854870 (UMLS CUI [2,1])
    C0004561 (UMLS CUI [2,2])
    C3888518 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0334634 (UMLS CUI [3,2])
    Measurable Disease
    Item
    measurable disease
    boolean
    C1513041 (UMLS CUI [1])
    Ineligibility High-Dose Chemotherapy with Autologous Stem Cell Transplant | High-Dose Chemotherapy with Autologous Stem Cell Transplant Unwilling
    Item
    ineligibility or unwillingness to undergo high-dose chemotherapy with autologous stem cell transplantation
    boolean
    C1512714 (UMLS CUI [1,1])
    C1512429 (UMLS CUI [1,2])
    C1512429 (UMLS CUI [2,1])
    C0558080 (UMLS CUI [2,2])
    Comprehension Study Protocol | Protocol Compliance
    Item
    ability to understand the aim of the study and act accordingly
    boolean
    C0162340 (UMLS CUI [1,1])
    C2348563 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [2])
    Contraceptive methods
    Item
    effective contraception
    boolean
    C0700589 (UMLS CUI [1])
    Informed Consent
    Item
    signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Central nervous system lymphoma Aggressive Relapse
    Item
    central nervous system relapse of aggressive lymphoma
    boolean
    C0280803 (UMLS CUI [1,1])
    C0580822 (UMLS CUI [1,2])
    C0205336 (UMLS CUI [1,3])
    Medical condition Study Subject Participation Status Excluded | Laboratory test result abnormal Study Subject Participation Status Excluded | Mental disorder Study Subject Participation Status Excluded
    Item
    any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study
    boolean
    C3843040 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C0332196 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C0332196 (UMLS CUI [2,3])
    C0004936 (UMLS CUI [3,1])
    C2348568 (UMLS CUI [3,2])
    C0332196 (UMLS CUI [3,3])
    Condition Study Subject Participation Status At risk | Laboratory test result abnormal Study Subject Participation Status At risk
    Item
    any condition including the presence of laboratory abnormalities which places the subject at unacceptable risk if he/she were to participate in the study
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0438215 (UMLS CUI [2,1])
    C2348568 (UMLS CUI [2,2])
    C1444641 (UMLS CUI [2,3])
    Condition Interferes with Interpretation Research data
    Item
    any condition that confounds the ability to interpret data from the study
    boolean
    C0348080 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0459471 (UMLS CUI [1,3])
    C0681873 (UMLS CUI [1,4])
    Organ function Inadequate | Relationship Absent Aggressive Lymphoma
    Item
    inadequate organ function not related to aggressive lymphoma:
    boolean
    C0678852 (UMLS CUI [1,1])
    C0205412 (UMLS CUI [1,2])
    C0439849 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    C1332225 (UMLS CUI [2,3])
    Neutrophil count
    Item
    neutrophils < 1.0/nl
    boolean
    C0200633 (UMLS CUI [1])
    Platelet Count measurement
    Item
    platelets < 75/nl
    boolean
    C0032181 (UMLS CUI [1])
    Creatinine clearance measurement
    Item
    creatinine clearance < 60 ml/min
    boolean
    C0373595 (UMLS CUI [1])
    Bilirubin measurement
    Item
    bilirubin ≥ 2,5 mg/dl
    boolean
    C0344395 (UMLS CUI [1])
    Aspartate aminotransferase increased | Alanine aminotransferase increased
    Item
    serum ast/got or alt/gpt ≥ 4 x upper limit of normal
    boolean
    C0151904 (UMLS CUI [1])
    C0151905 (UMLS CUI [2])
    Viral hepatitis | Hepatitis B | Hepatitis C | HIV Infection | Communicable Disease Uncontrolled
    Item
    active viral hepatitis (hbv, hcv), hiv infection, any other uncontrolled infection
    boolean
    C0042721 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    C0019693 (UMLS CUI [4])
    C0009450 (UMLS CUI [5,1])
    C0205318 (UMLS CUI [5,2])
    Pregnancy | Breast Feeding
    Item
    pregnancy and nursing period
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
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