0 Avaliações
ID

14571

Descrição

Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01083706

Link

https://clinicaltrials.gov/show/NCT01083706

Palavras-chave

Versões (1)
  1. 21/04/2016 21/04/2016 -
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21 de abril de 2016

DOI

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Licença

Creative Commons BY 4.0
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    Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

    Inglês

    Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

    1 Formulários  
    Inclusion Criteria
    Descrição

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    mds, cmml or aml patients (as diagnosed by world health organization [who] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
    Descrição

    mds

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (fish) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
    Descrição

    cytogenetic abnormalities

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0008625
    morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
    Descrição

    Myeloblast

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0229633
    flow cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
    Descrição

    Myeloblasts flow cytometric

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0580952
    UMLS CUI [1,2]
    C0201644
    extramedullary relapse (local radiotherapy will be allowed)
    Descrição

    extramedullary relapse

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C2854080
    mds, cmml, or aml patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
    Descrição

    mds, cmml, or aml patients

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    UMLS CUI [2]
    C0023480
    persistence of cytogenetic abnormalities by standard karyotype or fish
    Descrição

    cytogenetic abnormalities

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0008625
    persistent morphologic evidence of abnormal myeloblasts (in patients with cmml the monoblastoid population is included) in peripheral blood or marrow
    Descrição

    abnormal myeloblasts

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1,1]
    C0205161
    UMLS CUI [1,2]
    C0229633
    extramedullary persistence or regression
    Descrição

    Extramedullary

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1517060
    Exclusion Criteria
    Descrição

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by international working group (iwg) criteria
    Descrição

    Refractory Disease

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1514815
    >= 10% bone marrow myeloblasts as measured by morphology
    Descrição

    Bone marrow myeloblasts

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1993094
    evidence of central nervous system (cns) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [lp] is not required at time of relapse)
    Descrição

    central nervous system

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0007684
    serum creatinine > 2 x uln (upper limit of normal)
    Descrição

    serum creatinine

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    aspartate aminotransferase (ast)/ alanine aminotransferase (alt) > 2x uln
    Descrição

    aspartate aminotransferase

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    performance status > 2 (eastern cooperative oncology group [ecog] scale)
    Descrição

    eastern cooperative oncology group

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C1512162
    patients with severe disease other than mds, cmml or aml which would be expected to prevent compliance with treatment
    Descrição

    Protocol Compliance

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C0525058
    UMLS CUI [2]
    C0009488
    patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
    Descrição

    severe infections

    Tipo de dados

    boolean

    Alias
    UMLS CUI [1]
    C3714514
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    Similar models

    Eligibility Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities NCT01083706

    1 Formulários
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de dados
    Alias
    Item Group
    C1512693 (UMLS CUI)
    mds
    Item
    mds, cmml or aml patients (as diagnosed by world health organization [who] criteria) with evidence of relapse or progression at >= day 28 and < day 100 post-transplant
    boolean
    C3463824 (UMLS CUI [1])
    cytogenetic abnormalities
    Item
    recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence in situ hybridization (fish) (the cytogenetic abnormalities must have been previously documented at some time point between diagnosis and date of stem cell transplant)
    boolean
    C0008625 (UMLS CUI [1])
    Myeloblast
    Item
    morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral blood or marrow
    boolean
    C0229633 (UMLS CUI [1])
    Myeloblasts flow cytometric
    Item
    flow cytometric evidence of disease as determined by recurrent or increased abnormal myeloblasts in peripheral blood or marrow
    boolean
    C0580952 (UMLS CUI [1,1])
    C0201644 (UMLS CUI [1,2])
    extramedullary relapse
    Item
    extramedullary relapse (local radiotherapy will be allowed)
    boolean
    C2854080 (UMLS CUI [1])
    mds, cmml, or aml patients
    Item
    mds, cmml, or aml patients with persistent stable disease or persistent disease with regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with persistent stable or persistent regressing disease in this protocol is not meant to advocate treatment; however, if the attending physician is inclined to offer treatment then these patients would be eligible for this study
    boolean
    C3463824 (UMLS CUI [1])
    C0023480 (UMLS CUI [2])
    cytogenetic abnormalities
    Item
    persistence of cytogenetic abnormalities by standard karyotype or fish
    boolean
    C0008625 (UMLS CUI [1])
    abnormal myeloblasts
    Item
    persistent morphologic evidence of abnormal myeloblasts (in patients with cmml the monoblastoid population is included) in peripheral blood or marrow
    boolean
    C0205161 (UMLS CUI [1,1])
    C0229633 (UMLS CUI [1,2])
    Extramedullary
    Item
    extramedullary persistence or regression
    boolean
    C1517060 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Refractory Disease
    Item
    refractory disease at time of stem cell transplant; patients who received chemotherapy prior to transplant with no evidence of response by international working group (iwg) criteria
    boolean
    C1514815 (UMLS CUI [1])
    Bone marrow myeloblasts
    Item
    >= 10% bone marrow myeloblasts as measured by morphology
    boolean
    C1993094 (UMLS CUI [1])
    central nervous system
    Item
    evidence of central nervous system (cns) disease at time of relapse by morphology or flow (a diagnostic lumbar puncture [lp] is not required at time of relapse)
    boolean
    C0007684 (UMLS CUI [1])
    serum creatinine
    Item
    serum creatinine > 2 x uln (upper limit of normal)
    boolean
    C0201976 (UMLS CUI [1])
    aspartate aminotransferase
    Item
    aspartate aminotransferase (ast)/ alanine aminotransferase (alt) > 2x uln
    boolean
    C0201899 (UMLS CUI [1])
    eastern cooperative oncology group
    Item
    performance status > 2 (eastern cooperative oncology group [ecog] scale)
    boolean
    C1512162 (UMLS CUI [1])
    Protocol Compliance
    Item
    patients with severe disease other than mds, cmml or aml which would be expected to prevent compliance with treatment
    boolean
    C0525058 (UMLS CUI [1])
    C0009488 (UMLS CUI [2])
    severe infections
    Item
    patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to the anticipated start of protocol treatment
    boolean
    C3714514 (UMLS CUI [1])
    Voltar ao início da página 

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