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ID

12574

Beskrivning

Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01804101

Länk

https://clinicaltrials.gov/show/NCT01804101

Nyckelord

Versioner (1)
  1. 2015-12-02 2015-12-02 -
Uppladdad den

2 december 2015

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Acute Biphenotypic Leukemia NCT01804101

    Engelsk

    Eligibility Acute Biphenotypic Leukemia NCT01804101

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    Diagnosis of untreated high-risk myelodysplastic syndrome (>= 10% blasts) or aml
    Beskrivning

    other than acute promyelocytic leukemia (apl) with t(15;17)(q22;q12) or variants according to the 2008 world health organization (who) classification; patients with biphenotypic aml are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    UMLS CUI [2]
    C0026998
    prior hydroxyurea for aml is permitted but should be discontinued prior to start of cpx-351 treatment
    Beskrivning

    prior hydroxyurea for aml

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020402
    UMLS CUI [2]
    C0521104
    UMLS CUI [3]
    C1706472
    azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk mds (< 10% blasts); all treatments for mds should be discontinued prior to start of cpx-351 treatment
    Beskrivning

    discontinue treatment for myelodysplastic syndrome

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0584668
    treatment-related mortality (trm) score >= 13.1 as calculated with simplified model
    Beskrivning

    treatment-related mortality score

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0457450
    bilirubin < 2.0 mg/ml x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
    Beskrivning

    Liver function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 4.0 x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
    Beskrivning

    Liver function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    left ventricular ejection fraction (lvef) >= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (muga) scan or echocardiography, or other appropriate diagnostic modality
    Beskrivning

    left ventricular ejection fraction

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    patients with symptoms/signs of hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
    Beskrivning

    hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3805210
    UMLS CUI [2]
    C0023416
    provide signed written informed consent
    Beskrivning

    informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
    Beskrivning

    refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2861579
    UMLS CUI [2]
    C0205269
    concomitant illness associated with a likely survival of < 1 year
    Beskrivning

    Comorbidity with a likely survival of < 1 year

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C2919552
    active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
    Beskrivning

    infection, unless under treatment

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    UMLS CUI [2]
    C0087111
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    Similar models

    Eligibility Acute Biphenotypic Leukemia NCT01804101

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    untreated high-risk myelodysplastic syndrome or aml
    Item
    Diagnosis of untreated high-risk myelodysplastic syndrome (>= 10% blasts) or aml
    boolean
    C3463824 (UMLS CUI [1])
    C0026998 (UMLS CUI [2])
    prior hydroxyurea for aml
    Item
    prior hydroxyurea for aml is permitted but should be discontinued prior to start of cpx-351 treatment
    boolean
    C0020402 (UMLS CUI [1])
    C0521104 (UMLS CUI [2])
    C1706472 (UMLS CUI [3])
    discontinue treatment for myelodysplastic syndrome
    Item
    azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk mds (< 10% blasts); all treatments for mds should be discontinued prior to start of cpx-351 treatment
    boolean
    C0584668 (UMLS CUI [1])
    treatment-related mortality score
    Item
    treatment-related mortality (trm) score >= 13.1 as calculated with simplified model
    boolean
    C0457450 (UMLS CUI [1])
    Liver function
    Item
    bilirubin < 2.0 mg/ml x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
    boolean
    C0232741 (UMLS CUI [1])
    Liver function
    Item
    aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 4.0 x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
    boolean
    C0232741 (UMLS CUI [1])
    left ventricular ejection fraction
    Item
    left ventricular ejection fraction (lvef) >= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (muga) scan or echocardiography, or other appropriate diagnostic modality
    boolean
    C0428772 (UMLS CUI [1])
    hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
    Item
    patients with symptoms/signs of hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
    boolean
    C3805210 (UMLS CUI [1])
    C0023416 (UMLS CUI [2])
    informed consent
    Item
    provide signed written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
    Item
    refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
    boolean
    C2861579 (UMLS CUI [1])
    C0205269 (UMLS CUI [2])
    Comorbidity with a likely survival of < 1 year
    Item
    concomitant illness associated with a likely survival of < 1 year
    boolean
    C0009488 (UMLS CUI [1])
    C2919552 (UMLS CUI [2])
    infection, unless under treatment
    Item
    active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
    boolean
    C0009450 (UMLS CUI [1])
    C0087111 (UMLS CUI [2])
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