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ID

30174

Beskrivning

Everolimus, Cytarabine, and Daunorubicin in Treating Patients With Relapsed Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00544999

Länk

https://clinicaltrials.gov/show/NCT00544999

Nyckelord

Versioner (2)
  1. 2018-05-16 2018-05-16 -
  2. 2018-05-16 2018-05-16 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

16 maj 2018

DOI

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Licens

Creative Commons BY 4.0
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    Eligibility Leukemia NCT00544999

    Engelsk

    Eligibility Leukemia NCT00544999

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00544999
    Criteria
    Beskrivning

    Criteria

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
    Beskrivning

    Acute Myelocytic Leukemia de novo | Secondary acute myeloid leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1515568
    UMLS CUI [2]
    C0280449
    relapse > 1 year after obtaining complete remission (any prior treatment allowed)
    Beskrivning

    Recurrent disease Post Complete remission

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0277556
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C0677874
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    philadelphia chromosome-positive disease in blast crisis
    Beskrivning

    Disease Philadelphia chromosome positive Blast Phase

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C0856536
    UMLS CUI [1,3]
    C0005699
    fab m3, m6, or m7 disease
    Beskrivning

    Disease French-American-British Classification

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0012634
    UMLS CUI [1,2]
    C2984084
    patient characteristics:
    Beskrivning

    Client Characteristics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    life expectancy ≥ 4 weeks
    Beskrivning

    Life Expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    transaminases ≤ 5 times normal
    Beskrivning

    Transaminase Assay

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0919834
    creatinine ≤ 2 times normal
    Beskrivning

    Creatinine measurement, serum

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    bilirubin ≤ 3 times normal (except if visceral involvement present)
    Beskrivning

    Serum total bilirubin measurement | Exception Involvement Visceral

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C1314939
    UMLS CUI [2,3]
    C0442045
    alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
    Beskrivning

    Alkaline phosphatase measurement | Gamma glutamyl transferase measurement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201850
    UMLS CUI [2]
    C0202035
    not pregnant or nursing
    Beskrivning

    Pregnancy Absent | Breast Feeding Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C0332197
    UMLS CUI [2,1]
    C0006147
    UMLS CUI [2,2]
    C0332197
    negative pregnancy test
    Beskrivning

    Pregnancy test negative

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy
    Beskrivning

    Fertility Contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0015895
    UMLS CUI [1,2]
    C0700589
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    fev1 < 30%
    Beskrivning

    FEV1

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0849974
    active uncontrolled or viral pulmonary infection
    Beskrivning

    Infectious disease of lung Uncontrolled | Infectious disease of lung Viral

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0876973
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2,1]
    C0876973
    UMLS CUI [2,2]
    C0521026
    serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
    Beskrivning

    Serious mental illness Independent of Leukemia | Condition Preventing Comprehension Study Protocol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3841614
    UMLS CUI [1,2]
    C0332291
    UMLS CUI [1,3]
    C0023418
    UMLS CUI [2,1]
    C0348080
    UMLS CUI [2,2]
    C1292733
    UMLS CUI [2,3]
    C0162340
    UMLS CUI [2,4]
    C2348563
    hiv-positive
    Beskrivning

    HIV Seropositivity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
    Beskrivning

    Cancer Other | Exception Skin carcinoma Noninvasive | Exception Carcinoma in Situ Noninvasive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1707251
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [2,3]
    C2986496
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007099
    UMLS CUI [3,3]
    C2986496
    patients who are incarcerated or under supervision or trusteeship
    Beskrivning

    Patients In prison | Patient supervision | Guardianship

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C0392751
    UMLS CUI [2]
    C0814286
    UMLS CUI [3]
    C0870627
    prior concurrent therapy:
    Beskrivning

    Therapeutic procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    see disease characteristics
    Beskrivning

    ID.21

    Datatyp

    boolean

    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    prior experimental medication within the past 4 weeks
    Beskrivning

    Investigational New Drugs

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    Tillbaka till toppen

    Similar models

    Eligibility Leukemia NCT00544999

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00544999
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Item Group
    C1512693 (UMLS CUI)
    Acute Myelocytic Leukemia de novo | Secondary acute myeloid leukemia
    Item
    diagnosis of de novo or secondary acute myeloid leukemia meeting the following criterion:
    boolean
    C0023467 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    C0280449 (UMLS CUI [2])
    Recurrent disease Post Complete remission
    Item
    relapse > 1 year after obtaining complete remission (any prior treatment allowed)
    boolean
    C0277556 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C0677874 (UMLS CUI [1,3])
    Item Group
    C0680251 (UMLS CUI)
    Disease Philadelphia chromosome positive Blast Phase
    Item
    philadelphia chromosome-positive disease in blast crisis
    boolean
    C0012634 (UMLS CUI [1,1])
    C0856536 (UMLS CUI [1,2])
    C0005699 (UMLS CUI [1,3])
    Disease French-American-British Classification
    Item
    fab m3, m6, or m7 disease
    boolean
    C0012634 (UMLS CUI [1,1])
    C2984084 (UMLS CUI [1,2])
    Client Characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    Item Group
    C1512693 (UMLS CUI)
    Life Expectancy
    Item
    life expectancy ≥ 4 weeks
    boolean
    C0023671 (UMLS CUI [1])
    Transaminase Assay
    Item
    transaminases ≤ 5 times normal
    boolean
    C0919834 (UMLS CUI [1])
    Creatinine measurement, serum
    Item
    creatinine ≤ 2 times normal
    boolean
    C0201976 (UMLS CUI [1])
    Serum total bilirubin measurement | Exception Involvement Visceral
    Item
    bilirubin ≤ 3 times normal (except if visceral involvement present)
    boolean
    C1278039 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C1314939 (UMLS CUI [2,2])
    C0442045 (UMLS CUI [2,3])
    Alkaline phosphatase measurement | Gamma glutamyl transferase measurement
    Item
    alkaline phosphatase or gamma-glutamyltransferase ≤ 5 times normal
    boolean
    C0201850 (UMLS CUI [1])
    C0202035 (UMLS CUI [2])
    Pregnancy Absent | Breast Feeding Absent
    Item
    not pregnant or nursing
    boolean
    C0032961 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2,1])
    C0332197 (UMLS CUI [2,2])
    Pregnancy test negative
    Item
    negative pregnancy test
    boolean
    C0427780 (UMLS CUI [1])
    Fertility Contraceptive methods
    Item
    fertile patients of must use effective contraception during and for ≥ 28 days after completion of study therapy
    boolean
    C0015895 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    FEV1
    Item
    fev1 < 30%
    boolean
    C0849974 (UMLS CUI [1])
    Infectious disease of lung Uncontrolled | Infectious disease of lung Viral
    Item
    active uncontrolled or viral pulmonary infection
    boolean
    C0876973 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0876973 (UMLS CUI [2,1])
    C0521026 (UMLS CUI [2,2])
    Serious mental illness Independent of Leukemia | Condition Preventing Comprehension Study Protocol
    Item
    serious psychiatric disorders not related to leukemia or any condition that would prohibit comprehension of the study
    boolean
    C3841614 (UMLS CUI [1,1])
    C0332291 (UMLS CUI [1,2])
    C0023418 (UMLS CUI [1,3])
    C0348080 (UMLS CUI [2,1])
    C1292733 (UMLS CUI [2,2])
    C0162340 (UMLS CUI [2,3])
    C2348563 (UMLS CUI [2,4])
    HIV Seropositivity
    Item
    hiv-positive
    boolean
    C0019699 (UMLS CUI [1])
    Cancer Other | Exception Skin carcinoma Noninvasive | Exception Carcinoma in Situ Noninvasive
    Item
    other concurrent malignancy except noninvasive skin cancer or carcinoma in situ
    boolean
    C1707251 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C2986496 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0007099 (UMLS CUI [3,2])
    C2986496 (UMLS CUI [3,3])
    Patients In prison | Patient supervision | Guardianship
    Item
    patients who are incarcerated or under supervision or trusteeship
    boolean
    C0030705 (UMLS CUI [1,1])
    C0392751 (UMLS CUI [1,2])
    C0814286 (UMLS CUI [2])
    C0870627 (UMLS CUI [3])
    Therapeutic procedure
    Item
    prior concurrent therapy:
    boolean
    C0087111 (UMLS CUI [1])
    Item Group
    C1512693 (UMLS CUI)
    ID.21
    Item
    see disease characteristics
    boolean
    Item Group
    C0680251 (UMLS CUI)
    Investigational New Drugs
    Item
    prior experimental medication within the past 4 weeks
    boolean
    C0013230 (UMLS CUI [1])
    Tillbaka till toppen 

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