ID

13605

Beskrivning

Efficacy Study of Oral Sapacitabine to Treat Acute Myeloid Leukemia in Elderly Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00590187

Länk

https://clinicaltrials.gov/show/NCT00590187

Nyckelord

  1. 2016-02-19 2016-02-19 -
Rättsinnehavare

CC BY-NC 3.0

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19 februari 2016

DOI

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Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukemia NCT00590187

    Eligibility Acute Myeloid Leukemia NCT00590187

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
    Beskrivning

    a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [2]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    age 70 years or older for aml and 60 years or older for mds
    Beskrivning

    age 70 years or older for aml and 60 years or older for mds

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    eastern cooperative oncology group (ecog) performance status 0-2
    Beskrivning

    eastern cooperative oncology group (ecog) performance status 0-2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)
    Beskrivning

    adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)
    Beskrivning

    adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [2]
    C0201836 (Alanine aminotransferase measurement)
    SNOMED
    34608000
    life expectancy reasonably adequate for evaluating the treatment effect
    Beskrivning

    life expectancy reasonably adequate for evaluating the treatment effect

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    patient must be able to swallow capsules
    Beskrivning

    patient must be able to swallow capsules

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006935 (capsule (pharmacologic))
    SNOMED
    385049006
    LOINC
    LA21907-3
    patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
    Beskrivning

    patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1514457 (Prior Chemotherapy)
    UMLS CUI [2,1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [2,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [3,1]
    C0679637 (major surgery)
    UMLS CUI [3,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [4,1]
    C0949266 (Therapies, Investigational)
    UMLS CUI [4,2]
    C0332152 (Before)
    SNOMED
    236874000
    UMLS CUI [5]
    C2004454 (Recovery - healing process)
    all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
    Beskrivning

    all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    ability to understand and willingness to sign the informed consent form
    Beskrivning

    ability to understand and willingness to sign the informed consent form

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    aml is of the sub-type of acute promyelocytic leukemia
    Beskrivning

    aml is of the sub-type of acute promyelocytic leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
    Beskrivning

    having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3179010 (Induction Chemotherapy)
    SNOMED
    450827009
    UMLS CUI [1,2]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [2,1]
    C0010711 (cytarabine)
    SNOMED
    89265009
    UMLS CUI [2,2]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    patients with known central nervous system (cns) involvement by leukemia
    Beskrivning

    patients with known central nervous system (cns) involvement by leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0449389 (CNS involvement status)
    SNOMED
    260766009
    uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study
    Beskrivning

    uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    UMLS CUI [2,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [2,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [2,3]
    C0009488 (Comorbidity)
    known to be hiv-positive
    Beskrivning

    known to be hiv-positive

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1

    Similar models

    Eligibility Acute Myeloid Leukemia NCT00590187

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML or MDS
    Item
    a histologically or pathologically confirmed diagnosis of aml based on who classification which is previously untreated by systemic therapy or is in first relapse after achieving a complete remission to initial induction, consolidation and/or maintenance therapy or mds with ipss scores of intermediate -2 or higher risk risk which has been previously treated with hypomethylating agents
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    age
    Item
    age 70 years or older for aml and 60 years or older for mds
    boolean
    C0001779 (UMLS CUI [1])
    ecog
    Item
    eastern cooperative oncology group (ecog) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    renal function
    Item
    adequate renal function defined as serum creatinine equal to or less than 1.5 x upper limit of normal (uln)
    boolean
    C0201976 (UMLS CUI [1])
    liver function
    Item
    adequate liver function defined as total bilirubin or direct bilirubin equal to or less than 1.5 x uln; alanine aminotransferase (alt or sgpt) equal to or less than 2.5 x uln (5 x uln if tumor has affected the liver)
    boolean
    C1278039 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    life expectancy
    Item
    life expectancy reasonably adequate for evaluating the treatment effect
    boolean
    C0023671 (UMLS CUI [1])
    capsules
    Item
    patient must be able to swallow capsules
    boolean
    C0006935 (UMLS CUI [1])
    prior chemotherapy
    Item
    patients must be at least 2 weeks from prior systemic therapy, radiation therapy, major surgery, or other investigational therapy, and have recovered from clinically significant toxicities of these prior treatments
    boolean
    C1514457 (UMLS CUI [1])
    C1522449 (UMLS CUI [2,1])
    C0332152 (UMLS CUI [2,2])
    C0679637 (UMLS CUI [3,1])
    C0332152 (UMLS CUI [3,2])
    C0949266 (UMLS CUI [4,1])
    C0332152 (UMLS CUI [4,2])
    C2004454 (UMLS CUI [5])
    contraception
    Item
    all men and women of reproductive potential must agree to practice effective contraception for 4 weeks prior to study entry, during the entire study period and for one month after the study unless documentation of infertility exists
    boolean
    C0700589 (UMLS CUI [1])
    informed consent form
    Item
    ability to understand and willingness to sign the informed consent form
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    apl
    Item
    aml is of the sub-type of acute promyelocytic leukemia
    boolean
    C0023487 (UMLS CUI [1])
    induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
    Item
    having received more than one induction systemic therapy for aml or having received a standard dose or high dose ara-c containing regimen for mds
    boolean
    C3179010 (UMLS CUI [1,1])
    C0023467 (UMLS CUI [1,2])
    C0010711 (UMLS CUI [2,1])
    C3463824 (UMLS CUI [2,2])
    cns involvement by leukemia
    Item
    patients with known central nervous system (cns) involvement by leukemia
    boolean
    C0449389 (UMLS CUI [1])
    comorbidity
    Item
    uncontrolled intercurrent illness including, but not limited to ongoing or active infection, active cancer(s) other than aml, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. patients receiving intravenous antibiotics for infections that are under control may be included in this study
    boolean
    C0009488 (UMLS CUI [1])
    C1321605 (UMLS CUI [2,1])
    C0439801 (UMLS CUI [2,2])
    C0009488 (UMLS CUI [2,3])
    hiv
    Item
    known to be hiv-positive
    boolean
    C0019682 (UMLS CUI [1])

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