0 Avaliações
ID

13251

Descrição

Dendritic Cell Vaccination for Patients With Acute Myeloid Leukemia in Remission; ODM derived from: https://clinicaltrials.gov/show/NCT00834002

Link

https://clinicaltrials.gov/show/NCT00834002

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Versões (1)
  1. 26/01/2016 26/01/2016 -
Titular dos direitos

CC BY-NC 3.0

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26 de janeiro de 2016

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Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia (AML) NCT00834002

    Inglês

    Eligibility Acute Myeloid Leukemia (AML) NCT00834002

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. tumor type: acute myeloid leukemia (aml) according to the who criteria (ea at least 20% blasts in the marrow). all fab subtypes except m3. patients with myelodysplastic syndrome, category of refractory anemia with excess blasts (raeb): raeb i (who: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and raeb ii (who: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
    Descrição

    AML, MDS

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [2]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    2. extent of disease: remission (partial or complete) or smouldering course. complete remission (cr) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. this definition is related to the hematological remission if it is not specified. partial remission (pr) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
    Descrição

    remission

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0544452 (Disease remission)
    SNOMED
    277022003
    LOINC
    LA28783-1
    3. overexpression of wt1 rna (>50 copies of wt1 per 1000 copies abl in bone marrow or >2 copy/1000 copies abl in peripheral blood) as assessed by quantitative rt-pcr at the time of presentation.
    Descrição

    wt1 expression

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0694898 (WT1 gene)
    LOINC
    LP19772-0
    4. prior treatments : patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
    Descrição

    prior treatment

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1504389 (Stem cell transplant)
    5. age: ≥ 18 years
    Descrição

    age: ≥ 18 years

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    6. high risk of relapse because of (and/or) age > 60 years (if <60 y, no sibling allotransplant donor available) poor risk cytogenetic or molecular markers at presentation second complete remission after relapse hyperleukocytosis at presentation
    Descrição

    high risk of relapse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    7. performance status: who ps grade 0-1 (appendix b)
    Descrição

    WHO performance status

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    8. objectively assessable parameters of life expectancy: more than 3 months
    Descrição

    life expectancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    9. prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
    Descrição

    prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    10. no concomitant use of immunosuppressive drugs
    Descrição

    immunosuppressive agents

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0021081 (Immunosuppressive Agents)
    SNOMED
    69431002
    11. adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
    Descrição

    renal and liver function

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    12. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    Descrição

    absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    13. women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
    Descrição

    contraception

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
    Descrição

    malignancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    2. subjects who are pregnant
    Descrição

    pregnancy

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    3. subjects who have sensitivity to drugs that provide local anesthesia
    Descrição

    sensitivity to drugs that provide local anesthesia

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0002921 (Local anesthesia)
    SNOMED
    386761002
    4. age < 18 years
    Descrição

    age < 18 years

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
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    Similar models

    Eligibility Acute Myeloid Leukemia (AML) NCT00834002

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML, MDS
    Item
    1. tumor type: acute myeloid leukemia (aml) according to the who criteria (ea at least 20% blasts in the marrow). all fab subtypes except m3. patients with myelodysplastic syndrome, category of refractory anemia with excess blasts (raeb): raeb i (who: medullary blast count ≤ 10% and a peripheral blast count ≤ 5%) and raeb ii (who: medullary blast count > 10% and/or > 5% peripheral blasts) can be included in the study in absence of other non-experimental treatment modalities.
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    remission
    Item
    2. extent of disease: remission (partial or complete) or smouldering course. complete remission (cr) is defined as no blasts in the peripheral blood and no more than 5% blasts in the bone marrow. this definition is related to the hematological remission if it is not specified. partial remission (pr) is defined as a decrease of at least 50% in the percentage of blasts to 5 to 25% in the bone marrow aspirate. smouldering course is defined as a relatively low marrow blast count and slowly progressive disease.
    boolean
    C0544452 (UMLS CUI [1])
    wt1 expression
    Item
    3. overexpression of wt1 rna (>50 copies of wt1 per 1000 copies abl in bone marrow or >2 copy/1000 copies abl in peripheral blood) as assessed by quantitative rt-pcr at the time of presentation.
    boolean
    C0694898 (UMLS CUI [1])
    prior treatment
    Item
    4. prior treatments : patients must have received at least one prior antileukemic chemotherapeutic regimen and must be more than 1 month past the last treatment and/or 6 months past allogeneic/autologous stem cell transplantation.
    boolean
    C0392920 (UMLS CUI [1])
    C1504389 (UMLS CUI [2])
    age: ≥ 18 years
    Item
    5. age: ≥ 18 years
    boolean
    C0001779 (UMLS CUI [1])
    high risk of relapse
    Item
    6. high risk of relapse because of (and/or) age > 60 years (if <60 y, no sibling allotransplant donor available) poor risk cytogenetic or molecular markers at presentation second complete remission after relapse hyperleukocytosis at presentation
    boolean
    C0277556 (UMLS CUI [1])
    WHO performance status
    Item
    7. performance status: who ps grade 0-1 (appendix b)
    boolean
    C1298650 (UMLS CUI [1])
    life expectancy
    Item
    8. objectively assessable parameters of life expectancy: more than 3 months
    boolean
    C0023671 (UMLS CUI [1])
    prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
    Item
    9. prior and concomitant associated diseases allowed with the exception of underlying autoimmune disease and positive serology for hiv/hbv/hcv
    boolean
    C0009488 (UMLS CUI [1])
    immunosuppressive agents
    Item
    10. no concomitant use of immunosuppressive drugs
    boolean
    C0021081 (UMLS CUI [1])
    renal and liver function
    Item
    11. adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
    boolean
    C0201976 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
    Item
    12. absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    contraception
    Item
    13. women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
    boolean
    C0700589 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    malignancy
    Item
    1. subjects with concurrent additional malignancy (with exception of non-melanoma skin cancers and carcinoma in situ of the cervix)
    boolean
    C0006826 (UMLS CUI [1])
    pregnancy
    Item
    2. subjects who are pregnant
    boolean
    C0032961 (UMLS CUI [1])
    sensitivity to drugs that provide local anesthesia
    Item
    3. subjects who have sensitivity to drugs that provide local anesthesia
    boolean
    C0020517 (UMLS CUI [1,1])
    C0002921 (UMLS CUI [1,2])
    age < 18 years
    Item
    4. age < 18 years
    boolean
    C0001779 (UMLS CUI [1])
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