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ID

13605

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00590187

Stichworte

Versionen (1)
  1. 19.02.16 19.02.16 -
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CC BY-NC 3.0

Hochgeladen am

19. Februar 2016

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Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT00590187

    Englisch

    Eligibility Acute Myeloid Leukemia NCT00590187

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    age 70 years or older for aml and 60 years or older for mds
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    eastern cooperative oncology group (ecog) performance status 0-2
    Beschreibung

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

    Datentyp

    boolean

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

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    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)
    Beschreibung

    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)

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201836
    life expectancy reasonably adequate for evaluating the treatment effect
    Beschreibung

    life expectancy reasonably adequate for evaluating the treatment effect

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patient must be able to swallow capsules
    Beschreibung

    patient must be able to swallow capsules

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006935
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1514457
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0332152
    UMLS CUI [3,1]
    C0679637
    UMLS CUI [3,2]
    C0332152
    UMLS CUI [4,1]
    C0949266
    UMLS CUI [4,2]
    C0332152
    UMLS CUI [5]
    C2004454
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    ability to understand and willingness to sign the informed consent form
    Beschreibung

    ability to understand and willingness to sign the informed consent form

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    aml is of the sub-type of acute promyelocytic leukemia
    Beschreibung

    aml is of the sub-type of acute promyelocytic leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3179010
    UMLS CUI [1,2]
    C0023467
    UMLS CUI [2,1]
    C0010711
    UMLS CUI [2,2]
    C3463824
    patients with known central nervous system (cns) involvement by leukemia
    Beschreibung

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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0449389
    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
    Beschreibung

    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

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2,1]
    C1321605
    UMLS CUI [2,2]
    C0439801
    UMLS CUI [2,3]
    C0009488
    known to be hiv-positive
    Beschreibung

    known to be hiv-positive

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682
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    Ähnliche Modelle

    Eligibility Acute Myeloid Leukemia NCT00590187

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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