0 Avaliações
ID

36316

Descrição

Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma.; ODM derived from: https://clinicaltrials.gov/show/NCT01996865

Link

https://clinicaltrials.gov/show/NCT01996865

Palavras-chave

Versões (1)
  1. 02/05/2019 02/05/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

2 de maio de 2019

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Lymphoma, Non-Hodgkin NCT01996865

    Inglês

    Eligibility Lymphoma, Non-Hodgkin NCT01996865

    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
    histologically confirmed follicular lymphoma (grade 1, 2 or 3a), marginal zone lymphoma, or mantle cell lymphoma
    Descrição

    Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Mantle cell lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0024301
    UMLS CUI [1,2]
    C0432516
    UMLS CUI [2]
    C1367654
    UMLS CUI [3]
    C0334634
    must have documented relapsed, refractory or progressive disease after last treatment with systemic therapy
    Descrição

    Recurrent disease | Refractory Disease | Progressive Disease | Status post Systemic therapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    UMLS CUI [2]
    C1514815
    UMLS CUI [3]
    C1335499
    UMLS CUI [4,1]
    C0231290
    UMLS CUI [4,2]
    C1515119
    bi-dimensionally measurable disease
    Descrição

    Measurable Disease 2-Dimensional

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C1705052
    eastern cooperative oncology group (ecog) performance status ≤ 2
    Descrição

    ECOG performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate bone marrow function
    Descrição

    Bone Marrow function

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0005953
    UMLS CUI [1,2]
    C0031843
    willingness to follow pregnancy precautions
    Descrição

    Contraceptive methods

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or grade 3b follicular lymphoma
    Descrição

    Histology Except Follicular Lymphoma | Histology Except Marginal Zone Lymphoma | Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0344441
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0024301
    UMLS CUI [2,1]
    C0344441
    UMLS CUI [2,2]
    C0332300
    UMLS CUI [2,3]
    C1367654
    UMLS CUI [3]
    C0040682
    UMLS CUI [4,1]
    C0024301
    UMLS CUI [4,2]
    C0432516
    any medical condition (other than the underlying lymphoma) that requires chronic steroid use
    Descrição

    Medical condition Requirement Steroid use chronic | Exception Lymphoma

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3843040
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C0281991
    UMLS CUI [1,4]
    C0205191
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0024299
    subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
    Descrição

    Adrenal Cortex Hormones | Exception Dose U/day | Exception Dose Equivalent Prednisone

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001617
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0178602
    UMLS CUI [2,3]
    C0456683
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0178602
    UMLS CUI [3,3]
    C0205163
    UMLS CUI [3,4]
    C0032952
    systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
    Descrição

    Systemic therapy Lymphoma | Antibody therapy | Radioimmunotherapy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1515119
    UMLS CUI [1,2]
    C0024299
    UMLS CUI [2]
    C0281176
    UMLS CUI [3]
    C0085101
    known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
    Descrição

    Seropositive Hepatitis B Virus | Hepatitis B | Seropositive Hepatitis C virus | Hepatitis C | HIV Seropositivity | HIV Infections

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0521143
    UMLS CUI [1,2]
    C0019169
    UMLS CUI [2]
    C0019163
    UMLS CUI [3,1]
    C0521143
    UMLS CUI [3,2]
    C0220847
    UMLS CUI [4]
    C0019196
    UMLS CUI [5]
    C0019699
    UMLS CUI [6]
    C0019693
    known sensitivity or allergy to murine products
    Descrição

    Hypersensitivity Products Murine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1514468
    UMLS CUI [1,3]
    C0026809
    presence or history of central nervous system involvement by lymphoma. subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
    Descrição

    Central Nervous System Involvement with Lymphoma | At risk Thromboembolism | Prophylaxis Unwilling

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C3714787
    UMLS CUI [1,2]
    C1314939
    UMLS CUI [1,3]
    C0024299
    UMLS CUI [2,1]
    C1444641
    UMLS CUI [2,2]
    C0040038
    UMLS CUI [3,1]
    C0199176
    UMLS CUI [3,2]
    C0558080
    any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
    Descrição

    Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C2348568
    UMLS CUI [1,3]
    C1444641
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C0459471
    UMLS CUI [2,4]
    C0681873
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    Similar models

    Eligibility Lymphoma, Non-Hodgkin NCT01996865

    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])
    Follicular Lymphoma Ann Arbor lymphoma staging system | Marginal Zone Lymphoma | Mantle cell lymphoma
    Item
    histologically confirmed follicular lymphoma (grade 1, 2 or 3a), marginal zone lymphoma, or mantle cell lymphoma
    boolean
    C0024301 (UMLS CUI [1,1])
    C0432516 (UMLS CUI [1,2])
    C1367654 (UMLS CUI [2])
    C0334634 (UMLS CUI [3])
    Recurrent disease | Refractory Disease | Progressive Disease | Status post Systemic therapy
    Item
    must have documented relapsed, refractory or progressive disease after last treatment with systemic therapy
    boolean
    C0277556 (UMLS CUI [1])
    C1514815 (UMLS CUI [2])
    C1335499 (UMLS CUI [3])
    C0231290 (UMLS CUI [4,1])
    C1515119 (UMLS CUI [4,2])
    Measurable Disease 2-Dimensional
    Item
    bi-dimensionally measurable disease
    boolean
    C1513041 (UMLS CUI [1,1])
    C1705052 (UMLS CUI [1,2])
    ECOG performance status
    Item
    eastern cooperative oncology group (ecog) performance status ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    Bone Marrow function
    Item
    adequate bone marrow function
    boolean
    C0005953 (UMLS CUI [1,1])
    C0031843 (UMLS CUI [1,2])
    Contraceptive methods
    Item
    willingness to follow pregnancy precautions
    boolean
    C0700589 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Histology Except Follicular Lymphoma | Histology Except Marginal Zone Lymphoma | Transformation | Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    histology other than follicular or marginal zone lymphoma or clinical evidence of transformation or grade 3b follicular lymphoma
    boolean
    C0344441 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0024301 (UMLS CUI [1,3])
    C0344441 (UMLS CUI [2,1])
    C0332300 (UMLS CUI [2,2])
    C1367654 (UMLS CUI [2,3])
    C0040682 (UMLS CUI [3])
    C0024301 (UMLS CUI [4,1])
    C0432516 (UMLS CUI [4,2])
    Medical condition Requirement Steroid use chronic | Exception Lymphoma
    Item
    any medical condition (other than the underlying lymphoma) that requires chronic steroid use
    boolean
    C3843040 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C0281991 (UMLS CUI [1,3])
    C0205191 (UMLS CUI [1,4])
    C1705847 (UMLS CUI [2,1])
    C0024299 (UMLS CUI [2,2])
    Adrenal Cortex Hormones | Exception Dose U/day | Exception Dose Equivalent Prednisone
    Item
    subjects taking corticosteroids during the last 1 week prior treatment, unless administered at a dose equivalent to < 20 mg/day of prednisone
    boolean
    C0001617 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0178602 (UMLS CUI [2,2])
    C0456683 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0178602 (UMLS CUI [3,2])
    C0205163 (UMLS CUI [3,3])
    C0032952 (UMLS CUI [3,4])
    Systemic therapy Lymphoma | Antibody therapy | Radioimmunotherapy
    Item
    systemic anti-lymphoma therapy within 28 days or use of antibody agents within 8 weeks use of radioimmunotherapy within 3 months
    boolean
    C1515119 (UMLS CUI [1,1])
    C0024299 (UMLS CUI [1,2])
    C0281176 (UMLS CUI [2])
    C0085101 (UMLS CUI [3])
    Seropositive Hepatitis B Virus | Hepatitis B | Seropositive Hepatitis C virus | Hepatitis C | HIV Seropositivity | HIV Infections
    Item
    known seropositive for or active viral infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv)
    boolean
    C0521143 (UMLS CUI [1,1])
    C0019169 (UMLS CUI [1,2])
    C0019163 (UMLS CUI [2])
    C0521143 (UMLS CUI [3,1])
    C0220847 (UMLS CUI [3,2])
    C0019196 (UMLS CUI [4])
    C0019699 (UMLS CUI [5])
    C0019693 (UMLS CUI [6])
    Hypersensitivity Products Murine
    Item
    known sensitivity or allergy to murine products
    boolean
    C0020517 (UMLS CUI [1,1])
    C1514468 (UMLS CUI [1,2])
    C0026809 (UMLS CUI [1,3])
    Central Nervous System Involvement with Lymphoma | At risk Thromboembolism | Prophylaxis Unwilling
    Item
    presence or history of central nervous system involvement by lymphoma. subjects who are at a risk for a thromboembolic event and are not willing to take prophylaxis for it.
    boolean
    C3714787 (UMLS CUI [1,1])
    C1314939 (UMLS CUI [1,2])
    C0024299 (UMLS CUI [1,3])
    C1444641 (UMLS CUI [2,1])
    C0040038 (UMLS CUI [2,2])
    C0199176 (UMLS CUI [3,1])
    C0558080 (UMLS CUI [3,2])
    Condition Study Subject Participation Status At risk | Condition Interferes with Interpretation Research data
    Item
    any condition that places the subject at unacceptable risk if he/she were to participate in the study or that confounds the ability to interpret data from the study.
    boolean
    C0348080 (UMLS CUI [1,1])
    C2348568 (UMLS CUI [1,2])
    C1444641 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C0459471 (UMLS CUI [2,3])
    C0681873 (UMLS CUI [2,4])
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