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ID

13745

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01055483

Trefwoorden

  1. 02-03-16 02-03-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

2 maart 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukemia NCT01055483

    Eligibility Acute Myeloid Leukemia NCT01055483

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

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

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0456521
    UMLS CUI [2]
    C0023487
    first relapsed aml
    Beschrijving

    first relapsed aml

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0277556
    UMLS CUI [1,3]
    C0205435
    primary refractory aml defined as failure to respond to initial induction chemotherapy (no cr) or recurrence within 6 months of initial cr.
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0205269
    age more than 18 years
    Beschrijving

    age more than 18 years

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status < 2
    Beschrijving

    ecog performance status < 2

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior treatment with deacetylase inhibitor
    Beschrijving

    prior treatment with deacetylase inhibitor

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1512474
    UMLS CUI [1,2]
    C1514463
    concurrent therapy with any other investigational agent
    Beschrijving

    concurrent therapy with any other investigational agent

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1875319
    UMLS CUI [1,2]
    C0009429
    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.
    Beschrijving

    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.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013089
    UMLS CUI [1,2]
    C2986497
    clinical symptoms suggesting cns leukemia
    Beschrijving

    clinical symptoms suggesting cns leukemia

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1332884
    UMLS CUI [1,2]
    C1457887
    lvef below 45% other protocol-defined inclusion/exclusion criteria may apply
    Beschrijving

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

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0428772

    Similar models

    Eligibility Acute Myeloid Leukemia NCT01055483

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    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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