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ID

17820

Beskrivning

Combination Chemotherapy and Imatinib Mesylate in Treating Children With Relapsed Acute Lymphoblastic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00049569

Länk

https://clinicaltrials.gov/show/NCT00049569

Nyckelord

  1. 2016-10-04 2016-10-04 -
Uppladdad den

4 oktober 2016

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

    Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients with acute lymphoblastic leukemia (all) in first relapse involving the bone marrow (m3 marrow), with or without associated extramedullary disease; this includes patients who are philadelphia chromosome-positive
    Beskrivning

    Acute lymphocytic leukemia First Relapse | Bone Marrow Involvement with | Leukemic Blast Count | Disease Extramedullary | Philadelphia chromosome positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023449
    UMLS CUI [1,2]
    C4054953
    UMLS CUI [2,1]
    C0005953
    UMLS CUI [2,2]
    C1314939
    UMLS CUI [3]
    C2697913
    UMLS CUI [4,1]
    C0012634
    UMLS CUI [4,2]
    C1517060
    UMLS CUI [5]
    C0856536
    shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
    Beskrivning

    Shortening Fraction | Echocardiogram | Cardiac ejection fraction | Gated Blood-Pool Imaging

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1335957
    UMLS CUI [2]
    C2243117
    UMLS CUI [3]
    C0232174
    UMLS CUI [4]
    C0017200
    cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
    Beskrivning

    Anthracycline Previous Cumulative Exposure to | Idarubicin | Daunorubicin | Adriamycin

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0282564
    UMLS CUI [1,2]
    C0205156
    UMLS CUI [1,3]
    C1511559
    UMLS CUI [1,4]
    C0332157
    UMLS CUI [2]
    C0020789
    UMLS CUI [3]
    C0011015
    UMLS CUI [4]
    C0085752
    all patients and/or their parents or legal guardians must sign a written informed consent
    Beskrivning

    Informed Consent | Informed Consent parent | Informed Consent Legal Guardians

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030551
    UMLS CUI [3,1]
    C0021430
    UMLS CUI [3,2]
    C0023226
    all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
    Beskrivning

    Clinical Research criteria Fulfill

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0008972
    UMLS CUI [1,2]
    C0243161
    UMLS CUI [1,3]
    C1550543
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients with b-cell all (l3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
    Beskrivning

    B-cell childhood acute lymphoblastic leukemia | Leukemic Blast Count | Myc Translocation Evidence of | Molecular Diagnostic Techniques | Cytogenetic Analysis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0279584
    UMLS CUI [2]
    C2697913
    UMLS CUI [3,1]
    C1511357
    UMLS CUI [3,2]
    C0332120
    UMLS CUI [4]
    C0949688
    UMLS CUI [5]
    C0752095
    patients with down syndrome are excluded due to the administration of methotrexate in block 2
    Beskrivning

    Down Syndrome | Methotrexate

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013080
    UMLS CUI [2]
    C0025677
    patients who have undergone prior stem cell transplantation (sct) are ineligible if:
    Beskrivning

    Stem cell transplant Previous

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1504389
    UMLS CUI [1,2]
    C0205156
    they received sct less than 12 months prior to study entry
    Beskrivning

    Stem cell transplant Time Interval

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1504389
    UMLS CUI [1,2]
    C0872291
    they are still receiving immunosuppression for the treatment of graft-versus-host disease (gvhd)
    Beskrivning

    Therapeutic immunosuppression Graft-vs-Host Disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0021079
    UMLS CUI [1,2]
    C0018133
    they have active fungal infection at time of study entry
    Beskrivning

    Mycoses

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0026946
    they have had invasive filamentous fungal infection at any time post-sct
    Beskrivning

    Mycoses Filamentous Invasive Post Stem cell transplant

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0026946
    UMLS CUI [1,2]
    C1979891
    UMLS CUI [1,3]
    C0205281
    UMLS CUI [1,4]
    C0687676
    UMLS CUI [1,5]
    C1504389
    pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    patients with prior isolated extramedullary relapse are ineligible
    Beskrivning

    Relapse Extramedullary Isolated prior

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0035020
    UMLS CUI [1,2]
    C1517060
    UMLS CUI [1,3]
    C0205409
    UMLS CUI [1,4]
    C0332152

    Similar models

    Eligibility L1 Childhood Acute Lymphoblastic Leukemia NCT00049569

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Acute lymphocytic leukemia First Relapse | Bone Marrow Involvement with | Leukemic Blast Count | Disease Extramedullary | Philadelphia chromosome positive
    Item
    patients with acute lymphoblastic leukemia (all) in first relapse involving the bone marrow (m3 marrow), with or without associated extramedullary disease; this includes patients who are philadelphia chromosome-positive
    boolean
    C0023449 (UMLS CUI [1,1])
    C4054953 (UMLS CUI [1,2])
    C0005953 (UMLS CUI [2,1])
    C1314939 (UMLS CUI [2,2])
    C2697913 (UMLS CUI [3])
    C0012634 (UMLS CUI [4,1])
    C1517060 (UMLS CUI [4,2])
    C0856536 (UMLS CUI [5])
    Shortening Fraction | Echocardiogram | Cardiac ejection fraction | Gated Blood-Pool Imaging
    Item
    shortening fraction of >= 28% by echocardiogram, or ejection fraction of >= 50% by gated radionuclide study
    boolean
    C1335957 (UMLS CUI [1])
    C2243117 (UMLS CUI [2])
    C0232174 (UMLS CUI [3])
    C0017200 (UMLS CUI [4])
    Anthracycline Previous Cumulative Exposure to | Idarubicin | Daunorubicin | Adriamycin
    Item
    cumulative prior anthracycline exposure of =< 350 mg/m^2 (each 10 mg/m^2 dose of idarubicin should be calculated as the isotoxic equivalent of 50 mg/m^2 of daunorubicin or adriamycin)
    boolean
    C0282564 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    C1511559 (UMLS CUI [1,3])
    C0332157 (UMLS CUI [1,4])
    C0020789 (UMLS CUI [2])
    C0011015 (UMLS CUI [3])
    C0085752 (UMLS CUI [4])
    Informed Consent | Informed Consent parent | Informed Consent Legal Guardians
    Item
    all patients and/or their parents or legal guardians must sign a written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030551 (UMLS CUI [2,2])
    C0021430 (UMLS CUI [3,1])
    C0023226 (UMLS CUI [3,2])
    Clinical Research criteria Fulfill
    Item
    all institutional, food and drug administration (fda), and national cancer institute (nci) requirements for human studies must be met
    boolean
    C0008972 (UMLS CUI [1,1])
    C0243161 (UMLS CUI [1,2])
    C1550543 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    B-cell childhood acute lymphoblastic leukemia | Leukemic Blast Count | Myc Translocation Evidence of | Molecular Diagnostic Techniques | Cytogenetic Analysis
    Item
    patients with b-cell all (l3 morphology or evidence of myc translocation by molecular or cytogenetic technique) are not eligible
    boolean
    C0279584 (UMLS CUI [1])
    C2697913 (UMLS CUI [2])
    C1511357 (UMLS CUI [3,1])
    C0332120 (UMLS CUI [3,2])
    C0949688 (UMLS CUI [4])
    C0752095 (UMLS CUI [5])
    Down Syndrome | Methotrexate
    Item
    patients with down syndrome are excluded due to the administration of methotrexate in block 2
    boolean
    C0013080 (UMLS CUI [1])
    C0025677 (UMLS CUI [2])
    Stem cell transplant Previous
    Item
    patients who have undergone prior stem cell transplantation (sct) are ineligible if:
    boolean
    C1504389 (UMLS CUI [1,1])
    C0205156 (UMLS CUI [1,2])
    Stem cell transplant Time Interval
    Item
    they received sct less than 12 months prior to study entry
    boolean
    C1504389 (UMLS CUI [1,1])
    C0872291 (UMLS CUI [1,2])
    Therapeutic immunosuppression Graft-vs-Host Disease
    Item
    they are still receiving immunosuppression for the treatment of graft-versus-host disease (gvhd)
    boolean
    C0021079 (UMLS CUI [1,1])
    C0018133 (UMLS CUI [1,2])
    Mycoses
    Item
    they have active fungal infection at time of study entry
    boolean
    C0026946 (UMLS CUI [1])
    Mycoses Filamentous Invasive Post Stem cell transplant
    Item
    they have had invasive filamentous fungal infection at any time post-sct
    boolean
    C0026946 (UMLS CUI [1,1])
    C1979891 (UMLS CUI [1,2])
    C0205281 (UMLS CUI [1,3])
    C0687676 (UMLS CUI [1,4])
    C1504389 (UMLS CUI [1,5])
    Pregnancy | Breast Feeding
    Item
    pregnant or lactating females are ineligible as the medications used in this protocol could be harmful to unborn children and infants
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Relapse Extramedullary Isolated prior
    Item
    patients with prior isolated extramedullary relapse are ineligible
    boolean
    C0035020 (UMLS CUI [1,1])
    C1517060 (UMLS CUI [1,2])
    C0205409 (UMLS CUI [1,3])
    C0332152 (UMLS CUI [1,4])

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