ID

13167

Beskrivning

Phase I/II Study of 5-Azacytidine With Ara-C in Patients With Relapsed/Refractory Acute Myelogenous Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00569010

Länk

https://clinicaltrials.gov/show/NCT00569010

Nyckelord

  1. 2016-01-21 2016-01-21 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

21 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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    Eligibility Acute Myelogenous Leukemia NCT00569010

    Eligibility Acute Myelogenous Leukemia NCT00569010

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients must have histologically confirmed acute myeloid leukemia (aml) or high risk and previously treated myelodysplastic syndrome (mds).
    Beskrivning

    AML or MDS

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    2. patients with (1) refractory disease or (2) first relapse within 6 months of therapy or (3) 2nd or more of relapse of acute myelogenous leukemia (aml) or high risk myelodysplastic syndrome mds will be considered for the study.
    Beskrivning

    refractory disease or relapse

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0277556
    3. patients must have been off chemotherapy for 4 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
    Beskrivning

    chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    4. age >=18 years. deoxyribonucleic acid (dna) methylation plays a significant role in development, and the effects of azacitidine in children are not well described.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    5. patients must have normal organ as defined: total bilirubin <2 mg, aspartate aminotransferase (ast)/alanine aminotransferase (alt) <2.5 x institutional upper limit of normal, creatinine <2 mg
    Beskrivning

    normal organ function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0364051
    UMLS CUI [3]
    C0201976
    6. ability to understand and the willingness to sign a written informed consent document.
    Beskrivning

    written informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    7. women of child bearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
    Beskrivning

    pregnancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    8. women of child bearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacytidine.
    Beskrivning

    contraception

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    9. eastern cooperative oncology group (ecog) performance status 0-2.
    Beskrivning

    ecog performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, unless there is evidence of rapidly progressive disease. patients may have received hydroxyurea prior to entering the study.
    Beskrivning

    chemotherapy or radiotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    UMLS CUI [2]
    C1522449
    2. patients may not be receiving any other investigational agents for their leukemias.
    Beskrivning

    investigational agent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1875319
    3. patients with active brain or meningeal disease should be excluded.
    Beskrivning

    cns leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    4. known or suspected hypersensitivity to azacitidine or mannitol
    Beskrivning

    hypersensitivity to azacitidine or mannitol

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0004475
    UMLS CUI [2,1]
    C0020517
    UMLS CUI [2,2]
    C0024730
    5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
    Beskrivning

    illness that would limit compliance with study requirements

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0009488
    6. pregnant women are excluded from this study because azacitidine is a deoxyribonucleic acid (dna) methyltransferase inhibitor which has teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine.
    Beskrivning

    pregnancy or lactation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT00569010

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML or MDS
    Item
    1. patients must have histologically confirmed acute myeloid leukemia (aml) or high risk and previously treated myelodysplastic syndrome (mds).
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    refractory disease or relapse
    Item
    2. patients with (1) refractory disease or (2) first relapse within 6 months of therapy or (3) 2nd or more of relapse of acute myelogenous leukemia (aml) or high risk myelodysplastic syndrome mds will be considered for the study.
    boolean
    C0277556 (UMLS CUI [1])
    chemotherapy
    Item
    3. patients must have been off chemotherapy for 4 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
    boolean
    C0392920 (UMLS CUI [1])
    age
    Item
    4. age >=18 years. deoxyribonucleic acid (dna) methylation plays a significant role in development, and the effects of azacitidine in children are not well described.
    boolean
    C0001779 (UMLS CUI [1])
    normal organ function
    Item
    5. patients must have normal organ as defined: total bilirubin <2 mg, aspartate aminotransferase (ast)/alanine aminotransferase (alt) <2.5 x institutional upper limit of normal, creatinine <2 mg
    boolean
    C1278039 (UMLS CUI [1])
    C0364051 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    written informed consent
    Item
    6. ability to understand and the willingness to sign a written informed consent document.
    boolean
    C0021430 (UMLS CUI [1])
    pregnancy
    Item
    7. women of child bearing potential must have a negative serum pregnancy test prior to azacitidine treatment.
    boolean
    C0032961 (UMLS CUI [1])
    contraception
    Item
    8. women of child bearing potential should be advised to avoid becoming pregnant and men should be advised to not father a child while receiving treatment with azacytidine.
    boolean
    C0700589 (UMLS CUI [1])
    ecog performance status
    Item
    9. eastern cooperative oncology group (ecog) performance status 0-2.
    boolean
    C1520224 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    chemotherapy or radiotherapy
    Item
    1. patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin c) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier, unless there is evidence of rapidly progressive disease. patients may have received hydroxyurea prior to entering the study.
    boolean
    C0392920 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])
    investigational agent
    Item
    2. patients may not be receiving any other investigational agents for their leukemias.
    boolean
    C1875319 (UMLS CUI [1])
    cns leukemia
    Item
    3. patients with active brain or meningeal disease should be excluded.
    boolean
    C1332884 (UMLS CUI [1])
    hypersensitivity to azacitidine or mannitol
    Item
    4. known or suspected hypersensitivity to azacitidine or mannitol
    boolean
    C0020517 (UMLS CUI [1,1])
    C0004475 (UMLS CUI [1,2])
    C0020517 (UMLS CUI [2,1])
    C0024730 (UMLS CUI [2,2])
    illness that would limit compliance with study requirements
    Item
    5. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0009488 (UMLS CUI [1,3])
    pregnancy or lactation
    Item
    6. pregnant women are excluded from this study because azacitidine is a deoxyribonucleic acid (dna) methyltransferase inhibitor which has teratogenic or abortifacient effects. because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with azacitidine, breastfeeding should be discontinued if the mother is treated with azacitidine.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])

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