0 Ratings
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

Link

https://clinicaltrials.gov/show/NCT00515138

Keywords

Versions (2)
  1. 6/29/17 6/29/17 -
  2. 9/20/21 9/20/21 -
Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma, B-Cell NCT00515138

    English

    Eligibility Lymphoma, B-Cell NCT00515138

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    ID.1

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0855090
    UMLS CUI [1,2]
    C3888518
    UMLS CUI [1,3]
    C0392920
    diffuse large b-cell lymphoma, mantle cell lymphoma, follicular lymphoma (grade iii), transformed follicular lymphoma
    Description

    ID.2

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079744
    UMLS CUI [1,2]
    C0677725
    UMLS CUI [1,3]
    C0024301
    rituximab is allowed
    Description

    ID.3

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0393022
    prior radiation is allowed
    Description

    ID.4

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    18-70 years of age
    Description

    ID.5

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status of 0-2
    Description

    ID.6

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3541269
    hiv seronegative
    Description

    ID.7

    Data type

    boolean

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

    ID.8

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040405
    no cns involvement
    Description

    ID.9

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714787
    subject is considered to be a candidate for autologous stem cell transplant in the opinion of the treating physician
    Description

    ID.10

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C2193200
    female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control
    Description

    ID.11

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009862
    UMLS CUI [1,2]
    C0232970
    male subject agrees to use an acceptable method of contraception for the duration of the study
    Description

    ID.12

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009862
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    ID.13

    Data type

    boolean

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

    ID.14

    Data type

    boolean

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

    ID.15

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    subject has hypersensitivity to bortezomib, boron or mannitol.
    Description

    ID.17

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1176309
    UMLS CUI [1,2]
    C0006030
    UMLS CUI [1,3]
    C0024730
    UMLS CUI [1,4]
    C0020517
    female subject is pregnant or breast-feeding.
    Description

    ID.18

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    subject has been treated with more than one prior chemotherapy regimen.
    Description

    ID.19

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    subject has received other investigational drugs with 14 days before enrollment.
    Description

    ID.20

    Data type

    boolean

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

    ID.21

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0004936
    UMLS CUI [1,2]
    C0012634
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    Similar models

    Eligibility Lymphoma, B-Cell NCT00515138

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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