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ID

13251

Description

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

Lien

https://clinicaltrials.gov/show/NCT00834002

Mots-clés

Versions (1)
  1. 26/01/2016 26/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

26 janvier 2016

DOI

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Licence

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

    Anglais

    Eligibility Acute Myeloid Leukemia (AML) NCT00834002

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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.
    Description

    AML, MDS

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    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.
    Description

    remission

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0544452
    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.
    Description

    wt1 expression

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0694898
    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.
    Description

    prior treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1504389
    5. age: ≥ 18 years
    Description

    age: ≥ 18 years

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    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
    Description

    high risk of relapse

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    7. performance status: who ps grade 0-1 (appendix b)
    Description

    WHO performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    8. objectively assessable parameters of life expectancy: more than 3 months
    Description

    life expectancy

    Type de données

    boolean

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

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

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    10. no concomitant use of immunosuppressive drugs
    Description

    immunosuppressive agents

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021081
    11. adequate renal and liver function, i.e. creatinin and bilirubin = 1.2 times the upper limit of normal
    Description

    renal and liver function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C1278039
    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
    Description

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

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    13. women of child-bearing potential should use adequate contraception prior to study entry and for the duration of study participation
    Description

    contraception

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    malignancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    2. subjects who are pregnant
    Description

    pregnancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    3. subjects who have sensitivity to drugs that provide local anesthesia
    Description

    sensitivity to drugs that provide local anesthesia

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0002921
    4. age < 18 years
    Description

    age < 18 years

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Retour au début de la page

    Similar models

    Eligibility Acute Myeloid Leukemia (AML) NCT00834002

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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])
    Retour au début de la page 

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