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ID

13745

Beskrivning

A Phase Ib, Open-label, Multi-center Dose-finding Study of Oral Panobinostat (LBH589) in Combination With Ara-C and Mitoxantrone as Salvage Therapy for Refractory or Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01055483

Länk

https://clinicaltrials.gov/show/NCT01055483

Nyckelord

  1. 2016-03-02 2016-03-02 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

2 mars 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukemia NCT01055483

    Eligibility Acute Myeloid Leukemia NCT01055483

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
    Beskrivning

    patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0456521 (Cytopathology finding)
    SNOMED
    277194006
    UMLS CUI [2]
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    first relapsed aml
    Beskrivning

    first relapsed aml

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    UMLS CUI [1,3]
    C0205435 (First (number))
    SNOMED
    255216001
    LOINC
    LP96880-7
    primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
    Beskrivning

    primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0205269 (Unresponsive to Treatment)
    SNOMED
    20646008
    age more than 18 years
    Beskrivning

    age more than 18 years

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status < 2
    Beskrivning

    ecog performance status < 2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    prior treatment with deacetylase inhibitor
    Beskrivning

    prior treatment with deacetylase inhibitor

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1512474 (Histone deacetylase inhibitor)
    SNOMED
    423078004
    UMLS CUI [1,2]
    C1514463 (Prior Therapy)
    concurrent therapy with any other investigational agent
    Beskrivning

    concurrent therapy with any other investigational agent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1875319 (INVESTIGATIONAL AGENTS)
    UMLS CUI [1,2]
    C0009429 (Combined Modality Therapy)
    SNOMED
    229554006
    patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
    Beskrivning

    patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0013089 (doxorubicin)
    SNOMED
    68444001
    UMLS CUI [1,2]
    C2986497 (Cumulative Dose)
    clinical symptoms suggesting cns leukemia
    Beskrivning

    clinical symptoms suggesting cns leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1332884 (Central nervous system leukaemia)
    UMLS CUI [1,2]
    C1457887 (Symptoms)
    LOINC
    MTHU021540
    lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
    Beskrivning

    lvef below 45% other protocol-defined inclusion/exclusion criteria may apply

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004

    Similar models

    Eligibility Acute Myeloid Leukemia NCT01055483

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML cytopathologically confirmed, except APL
    Item
    patients with cytopathologically confirmed diagnosis of aml according to who criteria, excluding acute promyelocytic leukemia.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0456521 (UMLS CUI [1,2])
    C0023487 (UMLS CUI [2])
    first relapsed AML
    Item
    first relapsed aml
    boolean
    C0023467 (UMLS CUI [1,1])
    C0277556 (UMLS CUI [1,2])
    C0205435 (UMLS CUI [1,3])
    refractory aml
    Item
    primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0205269 (UMLS CUI [1,2])
    age
    Item
    age more than 18 years
    boolean
    C0001779 (UMLS CUI [1])
    ECOG
    Item
    ecog performance status < 2
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    deacetylase inhibitor
    Item
    prior treatment with deacetylase inhibitor
    boolean
    C1512474 (UMLS CUI [1,1])
    C1514463 (UMLS CUI [1,2])
    investigational agent
    Item
    concurrent therapy with any other investigational agent
    boolean
    C1875319 (UMLS CUI [1,1])
    C0009429 (UMLS CUI [1,2])
    doxorubicin cumulative dose
    Item
    patients who have received cumulative doses (or its equivalent to other anthracyclines) of more than 360 mg/m2 of doxorubicin will be excluded from the study.
    boolean
    C0013089 (UMLS CUI [1,1])
    C2986497 (UMLS CUI [1,2])
    cns leukemia
    Item
    clinical symptoms suggesting cns leukemia
    boolean
    C1332884 (UMLS CUI [1,1])
    C1457887 (UMLS CUI [1,2])
    LVEF
    Item
    lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
    boolean
    C0428772 (UMLS CUI [1])

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