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ID

13799

Descrizione

Trial of a WT-1 Analog Peptide Vaccine in Patients With Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01266083

collegamento

https://clinicaltrials.gov/show/NCT01266083

Keywords

versioni (1)
  1. 07/03/16 07/03/16 -
Titolare del copyright

CC BY-NC 3.0

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7 marzo 2016

DOI

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Licenza

Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT01266083

    Inglese

    Eligibility Acute Myeloid Leukemia NCT01266083

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    morphologic confirmation of a diagnosis of aml or all at mskcc
    Descrizione

    AML or ALL

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C0023449
    patients will have completed induction therapy, achieved 1st cr and will have completed any planned postremission therapy. patients are not candidates for allogeneic stem cell transplantation. for purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available hla matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by "good risk" features (for aml the following cyotogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated npm1 and negative for tandem duplication of flt-3. for all: t cell phenotype of any b lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st cr would not be offered as standard of care.
    Descrizione

    ID.2

    Tipo di dati

    boolean

    alternatively, those patients greater than or equal to 60 years of age who have achieved 1st cr and in whom no further postremission chemotherapy is planned may be enrolled
    Descrizione

    Age, remission

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2]
    C0677874
    UMLS CUI [3]
    C0392920
    patients must have documented wt1 + disease. for purpose of this study, this is defined as detectable presence of any wt1 transcript via rt-pcr on a bone marrow performed at mskcc within 4 weeks prior to the administration of the first dose of vaccine.
    Descrizione

    wt1

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0694898
    UMLS CUI [2]
    C0599161
    patients must be within 2 years of achieving cr following chemotherapy
    Descrizione

    complete remission following chemotherapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0040223
    UMLS CUI [1,2]
    C0677874
    UMLS CUI [1,3]
    C0332282
    UMLS CUI [1,4]
    C0392920
    at least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
    Descrizione

    time elapsed between last chemotherapy or radiation therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C2826303
    UMLS CUI [1,2]
    C0042196
    UMLS CUI [1,3]
    C0392920
    UMLS CUI [1,4]
    C1522449
    age > or = to 18 years
    Descrizione

    age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    karnofsky performance status > or = to 50%
    Descrizione

    karnofsky

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    absolute neutrophil count (anc) > or = to 1000/μl
    Descrizione

    ANC

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0948762
    platelets > 50k/ μl
    Descrizione

    platelets

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0005821
    total bilirubin < or = to 2.0 mg/dl ast and alt < or = to 2.5 x upper limits of normal
    Descrizione

    hepatic function

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1278039
    UMLS CUI [1,2]
    C0201836
    UMLS CUI [1,3]
    C0201899
    creatinine < or = to 2.0 mg/dl
    Descrizione

    creatinine

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    pregnant or lactating women
    Descrizione

    pregnancy or lactation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0006147
    patients with documented evidence of leptomeningeal disease
    Descrizione

    leptomeningeal disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0023418
    UMLS CUI [1,2]
    C0228126
    patients who have undergone autologous or allogeneic stem cell transplantation
    Descrizione

    autologous or allogeneic stem cell transplantation

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C1504389
    UMLS CUI [1,2]
    C0439859
    UMLS CUI [2,1]
    C1504389
    UMLS CUI [2,2]
    C1515895
    patients with active infection requiring systemic antimicrobials
    Descrizione

    active infection requiring systemic antimicrobials

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1136254
    patients taking systemic corticosteroids
    Descrizione

    systemic corticosteroids

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C4039704
    patients with serious unstable medical illness
    Descrizione

    comorbidity

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01266083

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML or ALL
    Item
    morphologic confirmation of a diagnosis of aml or all at mskcc
    boolean
    C0023467 (UMLS CUI [1])
    C0023449 (UMLS CUI [2])
    ID.2
    Item
    patients will have completed induction therapy, achieved 1st cr and will have completed any planned postremission therapy. patients are not candidates for allogeneic stem cell transplantation. for purposes of this study, patients who are not candidates for allogeneic stem cell transplantation shall be defined as 1) those who do not meet the eligibility criteria of an open allogeneic transplant protocol or 2) those who do not have a suitable available hla matched donor available or 3) those who refuse to undergo stem cell transplantation or 4) those patients whose disease is characterized by "good risk" features (for aml the following cyotogenetic subtypes: t(8;21), inv (16), or t(16;16), t(15;17), normal karyotype with mutated npm1 and negative for tandem duplication of flt-3. for all: t cell phenotype of any b lineage disease exclusive of t(9;22) or t(4;11) in whom allogenic stem cell transplantation in 1st cr would not be offered as standard of care.
    boolean
    Age, remission
    Item
    alternatively, those patients greater than or equal to 60 years of age who have achieved 1st cr and in whom no further postremission chemotherapy is planned may be enrolled
    boolean
    C0001779 (UMLS CUI [1])
    C0677874 (UMLS CUI [2])
    C0392920 (UMLS CUI [3])
    wt1
    Item
    patients must have documented wt1 + disease. for purpose of this study, this is defined as detectable presence of any wt1 transcript via rt-pcr on a bone marrow performed at mskcc within 4 weeks prior to the administration of the first dose of vaccine.
    boolean
    C0694898 (UMLS CUI [1])
    C0599161 (UMLS CUI [2])
    complete remission following chemotherapy
    Item
    patients must be within 2 years of achieving cr following chemotherapy
    boolean
    C0040223 (UMLS CUI [1,1])
    C0677874 (UMLS CUI [1,2])
    C0332282 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [1,4])
    time elapsed between last chemotherapy or radiation therapy
    Item
    at least 4 weeks must have elapsed between the patient's last chemotherapy or radiation treatment and the first vaccination.
    boolean
    C2826303 (UMLS CUI [1,1])
    C0042196 (UMLS CUI [1,2])
    C0392920 (UMLS CUI [1,3])
    C1522449 (UMLS CUI [1,4])
    age
    Item
    age > or = to 18 years
    boolean
    C0001779 (UMLS CUI [1])
    karnofsky
    Item
    karnofsky performance status > or = to 50%
    boolean
    C0206065 (UMLS CUI [1])
    ANC
    Item
    absolute neutrophil count (anc) > or = to 1000/μl
    boolean
    C0948762 (UMLS CUI [1])
    platelets
    Item
    platelets > 50k/ μl
    boolean
    C0005821 (UMLS CUI [1])
    hepatic function
    Item
    total bilirubin < or = to 2.0 mg/dl ast and alt < or = to 2.5 x upper limits of normal
    boolean
    C1278039 (UMLS CUI [1,1])
    C0201836 (UMLS CUI [1,2])
    C0201899 (UMLS CUI [1,3])
    creatinine
    Item
    creatinine < or = to 2.0 mg/dl
    boolean
    C0201976 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnancy or lactation
    Item
    pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1,1])
    C0006147 (UMLS CUI [1,2])
    leptomeningeal disease
    Item
    patients with documented evidence of leptomeningeal disease
    boolean
    C0023418 (UMLS CUI [1,1])
    C0228126 (UMLS CUI [1,2])
    autologous or allogeneic stem cell transplantation
    Item
    patients who have undergone autologous or allogeneic stem cell transplantation
    boolean
    C1504389 (UMLS CUI [1,1])
    C0439859 (UMLS CUI [1,2])
    C1504389 (UMLS CUI [2,1])
    C1515895 (UMLS CUI [2,2])
    active infection requiring systemic antimicrobials
    Item
    patients with active infection requiring systemic antimicrobials
    boolean
    C0009450 (UMLS CUI [1,1])
    C1136254 (UMLS CUI [1,2])
    systemic corticosteroids
    Item
    patients taking systemic corticosteroids
    boolean
    C4039704 (UMLS CUI [1])
    comorbidity
    Item
    patients with serious unstable medical illness
    boolean
    C0009488 (UMLS CUI [1])
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