ID

17998

Description

Rituximab and Combination Chemotherapy Followed By Thalidomide in Treating Patients With Previously Untreated Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00450801

Link

https://clinicaltrials.gov/show/NCT00450801

Keywords

Versions (1)
  1. 10/13/16 10/13/16 -
Uploaded on

October 13, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma NCT00450801

    English

    Eligibility Lymphoma NCT00450801

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00450801
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    disease characteristics:
    Description

    disease characteristic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0599878
    histologically confirmed mantle cell lymphoma
    Description

    Mantle cell lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0334634
    all stages allowed
    Description

    TNM clinical staging

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3258246
    previously untreated disease
    Description

    Disease untreated

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0332155
    measurable or evaluable disease
    Description

    Measurable Disease | Evaluable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1513041
    UMLS CUI [2]
    C1516986
    no cns involvement
    Description

    Central Nervous System Involvement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C4050309
    patient characteristics:
    Description

    Client Characteristics

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    ecog performance status 0-2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    life expectancy > 6 months
    Description

    Life Expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    bilirubin < 3 mg/dl
    Description

    Serum total bilirubin measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C0441949
    creatinine < 1.5 mg/dl
    Description

    Creatinine measurement, serum

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    not pregnant or nursing
    Description

    Pregnancy | Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    negative pregnancy test
    Description

    Pregnancy test negative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
    Description

    Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0700589
    UMLS CUI [2,1]
    C0015895
    UMLS CUI [2,2]
    C0004764
    UMLS CUI [3]
    C0039736
    no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
    Description

    Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0851140
    UMLS CUI [3]
    C0007117
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    grade 3-4 cardiac failure
    Description

    Heart failure | New York Heart Association Classification

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018801
    UMLS CUI [2]
    C1275491
    lvef that is less than ≥ 50%
    Description

    Left ventricular ejection fraction

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    psychological, familial, sociological, or geographical conditions that would preclude study compliance
    Description

    Condition Excludes Protocol Compliance

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0348080
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0525058
    known history of hiv or aids
    Description

    HIV | Acquired Immunodeficiency Syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0001175
    hepatitis or hepatitis b virus infection
    Description

    Hepatitis | Hepatitis B

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019158
    UMLS CUI [2]
    C0019163
    prior concurrent therapy:
    Description

    Prior Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1514463
    any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
    Description

    Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0334634
    UMLS CUI [2,1]
    C1514461
    UMLS CUI [2,2]
    C0334634
    UMLS CUI [3,1]
    C0279134
    UMLS CUI [3,2]
    C0334634
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    Similar models

    Eligibility Lymphoma NCT00450801

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00450801
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    disease characteristic
    Item
    disease characteristics:
    boolean
    C0599878 (UMLS CUI [1])
    Mantle cell lymphoma
    Item
    histologically confirmed mantle cell lymphoma
    boolean
    C0334634 (UMLS CUI [1])
    TNM clinical staging
    Item
    all stages allowed
    boolean
    C3258246 (UMLS CUI [1])
    Disease untreated
    Item
    previously untreated disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    Measurable Disease | Evaluable Disease
    Item
    measurable or evaluable disease
    boolean
    C1513041 (UMLS CUI [1])
    C1516986 (UMLS CUI [2])
    Central Nervous System Involvement
    Item
    no cns involvement
    boolean
    C4050309 (UMLS CUI [1])
    Client Characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    ECOG performance status
    Item
    ecog performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    Life Expectancy
    Item
    life expectancy > 6 months
    boolean
    C0023671 (UMLS CUI [1])
    Serum total bilirubin measurement
    Item
    bilirubin < 3 mg/dl
    boolean
    C1278039 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Lymphomatous nodal involvement
    Item
    sgot and/or sgpt < 2.5 times upper limit of normal (unless due to lymphomatous involvement)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C0441949 (UMLS CUI [3])
    Creatinine measurement, serum
    Item
    creatinine < 1.5 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    not pregnant or nursing
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Pregnancy test negative
    Item
    negative pregnancy test
    boolean
    C0427780 (UMLS CUI [1])
    Fertility Contraceptive methods | Fertility Contraception, Barrier | Thalidomide
    Item
    fertile patients must use effective double-method contraception during and for ≥ 4 weeks after completion of study treatment (if receiving thalidomide)
    boolean
    C0015895 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    C0015895 (UMLS CUI [2,1])
    C0004764 (UMLS CUI [2,2])
    C0039736 (UMLS CUI [3])
    Malignant Neoplasms | Carcinoma in situ of uterine cervix | Basal cell carcinoma
    Item
    no other concurrent active malignancies, except for in situ carcinoma of the cervix or basal cell carcinoma of the skin
    boolean
    C0006826 (UMLS CUI [1])
    C0851140 (UMLS CUI [2])
    C0007117 (UMLS CUI [3])
    Item Group
    C0680251 (UMLS CUI)
    Heart failure | New York Heart Association Classification
    Item
    grade 3-4 cardiac failure
    boolean
    C0018801 (UMLS CUI [1])
    C1275491 (UMLS CUI [2])
    Left ventricular ejection fraction
    Item
    lvef that is less than ≥ 50%
    boolean
    C0428772 (UMLS CUI [1])
    Condition Excludes Protocol Compliance
    Item
    psychological, familial, sociological, or geographical conditions that would preclude study compliance
    boolean
    C0348080 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    HIV | Acquired Immunodeficiency Syndrome
    Item
    known history of hiv or aids
    boolean
    C0019682 (UMLS CUI [1])
    C0001175 (UMLS CUI [2])
    Hepatitis | Hepatitis B
    Item
    hepatitis or hepatitis b virus infection
    boolean
    C0019158 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    Prior Therapy
    Item
    prior concurrent therapy:
    boolean
    C1514463 (UMLS CUI [1])
    Prior Chemotherapy Mantle cell lymphoma | Prior Immunotherapy Mantle cell lymphoma | prior radiation therapy Mantle cell lymphoma
    Item
    any prior chemotherapy, immunotherapy, or radiotherapy for this lymphoma
    boolean
    C1514457 (UMLS CUI [1,1])
    C0334634 (UMLS CUI [1,2])
    C1514461 (UMLS CUI [2,1])
    C0334634 (UMLS CUI [2,2])
    C0279134 (UMLS CUI [3,1])
    C0334634 (UMLS CUI [3,2])
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