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ID

13627

Description

Pivotal Study of Iodine I 131 Tositumomab for Chemotherapy-refractory Low-grade or Transformed Low-grade B-cell Non-Hodgkin's Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00989664

Lien

https://clinicaltrials.gov/show/NCT00989664

Mots-clés

  1. 21/02/2016 21/02/2016 -
Téléchargé le

21 février 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Lymphoma, Non-Hodgkin NCT00989664

    Eligibility Lymphoma, Non-Hodgkin NCT00989664

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
    Description

    Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0001779
    UMLS CUI [3]
    C1514457
    UMLS CUI [4]
    C0278885
    UMLS CUI [5]
    C0079747
    UMLS CUI [6]
    C1536010
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
    Description

    lymphoma involvment of bone marrow, iliac crest biopsy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1301440
    UMLS CUI [2]
    C0229621
    UMLS CUI [3]
    C0005954
    cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
    Description

    chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    UMLS CUI [3]
    C0021081
    UMLS CUI [4]
    C0199974
    prior stem cell transplant.
    Description

    stem cell transplant

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1504389
    active obstructive hydronephrosis.
    Description

    obstructive hydronephrosis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0020295
    evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
    Description

    active infection with iv antibiotics

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0559680
    new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
    Description

    new york heart association or other comorbidity precluding evaluation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1275491
    UMLS CUI [2]
    C0009488
    prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
    Description

    malignancies

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    known hiv infection.
    Description

    hiv

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    known brain or leptomeningeal metastases.
    Description

    brain metastases, leptomeningeal metastases

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2]
    C1704231
    subjects who are pregnant or nursing.
    Description

    pregnant or nursing

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
    Description

    allergic reactions to iodine

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0021968
    prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
    Description

    Antibodies

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0003241
    prior radioimmunotherapy.
    Description

    prior radioimmunotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0085101
    progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
    Description

    progressive disease after radiation, radation dosage

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0677932
    UMLS CUI [2]
    C0521982
    UMLS CUI [3]
    C0034524
    current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
    Description

    cancer therapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0920425
    de novo intermediate- or high-grade lymphoma.
    Description

    de novo intermediate- or high-grade lymphoma

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0079741
    UMLS CUI [2]
    C0079740

    Similar models

    Eligibility Lymphoma, Non-Hodgkin NCT00989664

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Gender, Age, prior chemotherapy, low-grade lymphoma (NHL) transformed
    Item
    male and female subjects ≥18 years of age with histologically confirmed at initial diagnosis, previously treated (at least 2 prior chemotherapy regimens), low-grade nhl or low-grade lymphoma that had transformed to intermediate- or high-grade histology.
    boolean
    C0079399 (UMLS CUI [1])
    C0001779 (UMLS CUI [2])
    C1514457 (UMLS CUI [3])
    C0278885 (UMLS CUI [4])
    C0079747 (UMLS CUI [5])
    C1536010 (UMLS CUI [6])
    Item Group
    C0680251 (UMLS CUI)
    lymphoma involvment of bone marrow, iliac crest biopsy
    Item
    subjects with more than an average of 25% of the intratrabecular marrow space involved by lymphoma in bone marrow biopsy specimens as assessed microscopically within 42 days of study entry. bilateral posterior iliac crest core biopsies are required if the percentage of intratrebecular space involved exceeds 10% in a unilateral biopsy. the mean of bilateral biopsies must be no more than 25%.
    boolean
    C1301440 (UMLS CUI [1])
    C0229621 (UMLS CUI [2])
    C0005954 (UMLS CUI [3])
    chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment
    Item
    cytotoxic chemotherapy, radiation therapy, immunosuppressants, or cytokine treatment within 4 weeks prior to study entry or persistent clinical evidence of toxicity.
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    C0021081 (UMLS CUI [3])
    C0199974 (UMLS CUI [4])
    stem cell transplant
    Item
    prior stem cell transplant.
    boolean
    C1504389 (UMLS CUI [1])
    obstructive hydronephrosis
    Item
    active obstructive hydronephrosis.
    boolean
    C0020295 (UMLS CUI [1])
    active infection with iv antibiotics
    Item
    evidence of active infection requiring intravenous (iv) antibiotics at the time of study entry.
    boolean
    C0009450 (UMLS CUI [1])
    C0559680 (UMLS CUI [2])
    new york heart association or other comorbidity precluding evaluation
    Item
    new york heart association class iii or iv heart disease or other serious illness that would preclude evaluation.
    boolean
    C1275491 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    malignancies
    Item
    prior malignancy other than lymphoma, except for adequately treated skin cancer, in situ cervical cancer, or other cancer for which the subject has been disease-free for 5 years.
    boolean
    C0006826 (UMLS CUI [1])
    hiv
    Item
    known hiv infection.
    boolean
    C0019682 (UMLS CUI [1])
    brain metastases, leptomeningeal metastases
    Item
    known brain or leptomeningeal metastases.
    boolean
    C0220650 (UMLS CUI [1])
    C1704231 (UMLS CUI [2])
    pregnant or nursing
    Item
    subjects who are pregnant or nursing.
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    allergic reactions to iodine
    Item
    previous allergic reactions to iodine. this does not include reactions to intravenous iodine-containing contrast materials.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0021968 (UMLS CUI [1,2])
    Antibodies
    Item
    prior exposure to monoclonal or polyclonal antibodies of any non-human species for either diagnostic or therapeutic purposes, including engineered chimeric and humanized antibodies.
    boolean
    C0003241 (UMLS CUI [1])
    prior radioimmunotherapy
    Item
    prior radioimmunotherapy.
    boolean
    C0085101 (UMLS CUI [1])
    progressive disease after radiation, radation dosage
    Item
    progressive disease within 1 year of irradiation arising in a field that has been previously irradiated with >3500 cgy.
    boolean
    C0677932 (UMLS CUI [1])
    C0521982 (UMLS CUI [2])
    C0034524 (UMLS CUI [3])
    cancer therapy
    Item
    current use of either approved or non-approved (through another protocol) anti-cancer drugs or biologics
    boolean
    C0920425 (UMLS CUI [1])
    de novo intermediate- or high-grade lymphoma
    Item
    de novo intermediate- or high-grade lymphoma.
    boolean
    C0079741 (UMLS CUI [1])
    C0079740 (UMLS CUI [2])

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