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ID

13167

Description

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

Lien

https://clinicaltrials.gov/show/NCT00569010

Mots-clés

  1. 21/01/2016 21/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

21 janvier 2016

DOI

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Licence

Creative Commons BY-NC 3.0

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    Eligibility Acute Myelogenous Leukemia NCT00569010

    Eligibility Acute Myelogenous Leukemia NCT00569010

    Inclusion Criteria
    Description

    Inclusion Criteria

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

    AML or MDS

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [2]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    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.
    Description

    refractory disease or relapse

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    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.
    Description

    chemotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    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.
    Description

    age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    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
    Description

    normal organ function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    UMLS CUI [2]
    C0364051 (Aspartate aminotransferase/Alanine aminotransferase:CRto:Pt:Ser/Plas:Qn)
    LOINC
    1916-6
    UMLS CUI [3]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    6. ability to understand and the willingness to sign a written informed consent document.
    Description

    written informed consent

    Type de données

    boolean

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

    pregnancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    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.
    Description

    contraception

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    9. eastern cooperative oncology group (ecog) performance status 0-2.
    Description

    ecog performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    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.
    Description

    chemotherapy or radiotherapy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    UMLS CUI [2]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    2. patients may not be receiving any other investigational agents for their leukemias.
    Description

    investigational agent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1875319 (INVESTIGATIONAL AGENTS)
    3. patients with active brain or meningeal disease should be excluded.
    Description

    cns leukemia

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1332884 (Central nervous system leukaemia)
    4. known or suspected hypersensitivity to azacitidine or mannitol
    Description

    hypersensitivity to azacitidine or mannitol

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [1,2]
    C0004475 (azacitidine)
    SNOMED
    412329008
    UMLS CUI [2,1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2,2]
    C0024730 (mannitol)
    SNOMED
    30761007
    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.
    Description

    illness that would limit compliance with study requirements

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0009488 (Comorbidity)
    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.
    Description

    pregnancy or lactation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT00569010

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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