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ID

43879

Description

A Pilot Study of Standard-Dose Rituximab, Ifosfamide, Carboplatin and Etoposide (RICE) Plus Bortezomib (Velcade) in a Dose-Escalating Fashion for Patients With Relapsed or Primary Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma Who Are Candidates for Autologous Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT00515138

Lien

https://clinicaltrials.gov/show/NCT00515138

Mots-clés

Versions (2)
  1. 29/06/2017 29/06/2017 -
  2. 20/09/2021 20/09/2021 -
Téléchargé le

20 septembre 2021

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT00515138

    Anglais

    Eligibility Lymphoma, B-Cell NCT00515138

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    aggressive b-cell lymphoma, cd-20 positive, in first relapse or refractory to first-line chemotherapy
    Description

    ID.1

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0855090 (B-cell lymphoma refractory)
    UMLS CUI [1,2]
    C3888518 (CD20 antigen positive)
    UMLS CUI [1,3]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma (grade iii), transformed follicular lymphoma
    Description

    ID.2

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744 (Diffuse Large B-Cell Lymphoma)
    SNOMED
    109969005
    UMLS CUI [1,2]
    C0677725 (Mantle cell lymphoma recurrent)
    UMLS CUI [1,3]
    C0024301 (Lymphoma, Follicular)
    SNOMED
    55150002
    rituximab is allowed
    Description

    ID.3

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0393022 (rituximab)
    SNOMED
    108809004
    prior radiation is allowed
    Description

    ID.4

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    18-70 years of age
    Description

    ID.5

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status of 0-2
    Description

    ID.6

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3541269 (Eastern Cooperative Oncology Group Performance Status Questionnaire)
    hiv seronegative
    Description

    ID.7

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019698 (HIV Seronegativity)
    measurable disease on ct scan by international working group response criteria
    Description

    ID.8

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0040405 (X-Ray Computed Tomography)
    SNOMED
    77477000
    LOINC
    LP6207-7
    no cns involvement
    Description

    ID.9

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3714787 (Central Nervous System)
    SNOMED
    21483005
    LOINC
    LA4174-4
    subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
    Description

    ID.10

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2193200 (Autologous haematopoietic stem cell transplant)
    female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
    Description

    ID.11

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009862 (Contraception Behavior)
    UMLS CUI [1,2]
    C0232970 (Postmenopausal state)
    SNOMED
    76498008
    male subject agrees to use an acceptable method of contraception for the duration of the study
    Description

    ID.12

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009862 (Contraception Behavior)
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    platelet count of <75 x 10(9)/l
    Description

    ID.13

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032181 (Platelet Count measurement)
    SNOMED
    61928009
    absolute neutrophil count of <1.0 x 10(9)/l
    Description

    ID.14

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0151683 (Neutrophilia (finding))
    SNOMED
    165518003
    calculated or measured creatinine clearance of <60 ml/minute within 14 days before enrollment
    Description

    ID.15

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    myocardial infarction within 6 months prior to enrollment or has new york hospital association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
    Description

    ID.16

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018799 (Heart Diseases)
    SNOMED
    56265001
    subject has hypersensitivity to bortezomib, boron or mannitol.
    Description

    ID.17

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1176309 (bortezomib)
    SNOMED
    398907002
    UMLS CUI [1,2]
    C0006030 (boron)
    SNOMED
    70597009
    UMLS CUI [1,3]
    C0024730 (mannitol)
    SNOMED
    30761007
    UMLS CUI [1,4]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    female subject is pregnant or breast-feeding.
    Description

    ID.18

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [1,2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    subject has been treated with more than one prior chemotherapy regimen.
    Description

    ID.19

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    subject has received other investigational drugs with 14 days before enrollment.
    Description

    ID.20

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    serious medical or psychiatric illness likely to interfere with participation in this clinical study.
    Description

    ID.21

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936 (Mental disorders)
    SNOMED
    74732009
    UMLS CUI [1,2]
    C0012634 (Disease)
    SNOMED
    64572001
    LOINC
    LP21006-9
    Retour au début de la page

    Similar models

    Eligibility Lymphoma, B-Cell NCT00515138

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    ID.1
    Item
    aggressive b-cell lymphoma, cd-20 positive, in first relapse or refractory to first-line chemotherapy
    boolean
    C0855090 (UMLS CUI [1,1])
    C3888518 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    ID.2
    Item
    diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma (grade iii), transformed follicular lymphoma
    boolean
    C0079744 (UMLS CUI [1,1])
    C0677725 (UMLS CUI [1,2])
    C0024301 (UMLS CUI [1,3])
    ID.3
    Item
    rituximab is allowed
    boolean
    C0393022 (UMLS CUI [1])
    ID.4
    Item
    prior radiation is allowed
    boolean
    C1522449 (UMLS CUI [1])
    ID.5
    Item
    18-70 years of age
    boolean
    C0001779 (UMLS CUI [1])
    ID.6
    Item
    ecog performance status of 0-2
    boolean
    C3541269 (UMLS CUI [1])
    ID.7
    Item
    hiv seronegative
    boolean
    C0019698 (UMLS CUI [1])
    ID.8
    Item
    measurable disease on ct scan by international working group response criteria
    boolean
    C0040405 (UMLS CUI [1])
    ID.9
    Item
    no cns involvement
    boolean
    C3714787 (UMLS CUI [1])
    ID.10
    Item
    subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
    boolean
    C2193200 (UMLS CUI [1])
    ID.11
    Item
    female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
    boolean
    C0009862 (UMLS CUI [1,1])
    C0232970 (UMLS CUI [1,2])
    ID.12
    Item
    male subject agrees to use an acceptable method of contraception for the duration of the study
    boolean
    C0009862 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    ID.13
    Item
    platelet count of <75 x 10(9)/l
    boolean
    C0032181 (UMLS CUI [1])
    ID.14
    Item
    absolute neutrophil count of <1.0 x 10(9)/l
    boolean
    C0151683 (UMLS CUI [1])
    ID.15
    Item
    calculated or measured creatinine clearance of <60 ml/minute within 14 days before enrollment
    boolean
    C0373595 (UMLS CUI [1])
    ID.16
    Item
    myocardial infarction within 6 months prior to enrollment or has new york hospital association class iii or iv heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. prior to study entry, any ecg abnormality at screening has to be documented by the investigator as not medically relevant.
    boolean
    C0018799 (UMLS CUI [1])
    ID.17
    Item
    subject has hypersensitivity to bortezomib, boron or mannitol.
    boolean
    C1176309 (UMLS CUI [1,1])
    C0006030 (UMLS CUI [1,2])
    C0024730 (UMLS CUI [1,3])
    C0020517 (UMLS CUI [1,4])
    ID.18
    Item
    female subject is pregnant or breast-feeding.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    ID.19
    Item
    subject has been treated with more than one prior chemotherapy regimen.
    boolean
    C0392920 (UMLS CUI [1])
    ID.20
    Item
    subject has received other investigational drugs with 14 days before enrollment.
    boolean
    C0013230 (UMLS CUI [1])
    ID.21
    Item
    serious medical or psychiatric illness likely to interfere with participation in this clinical study.
    boolean
    C0004936 (UMLS CUI [1,1])
    C0012634 (UMLS CUI [1,2])
    Retour au début de la page 

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