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ID

44778

Descrizione

Safety and Efficacy Study of AS101 to Treat Elderly Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT01010373

collegamento

https://clinicaltrials.gov/show/NCT01010373

Keywords

versioni (3)
  1. 01/09/15 01/09/15 -
  2. 13/04/21 13/04/21 - Dr. rer. medic Philipp Neuhaus
  3. 18/11/21 18/11/21 -
Titolare del copyright

BioMAS Ltd

Caricato su

18 novembre 2021

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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    Eligibility Acute Myeloid Leukemia NCT01010373

    Inglese

    Eligibility Acute Myeloid Leukemia NCT01010373

    1 moduli  
    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    confirmed diagnosis of primary aml or aml transformed myelodysplastic syndrome (mds) with fab classification other than m3 as proven by bone marrow aspiration.
    Descrizione

    myelodysplastic syndrome; bone marrow; diagnosis; aspiration; confirmed; other; primary; fab

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    UMLS CUI [2]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    age ≥60 years.
    Descrizione

    age

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    ecog performance status of 0-2 (karnofsky >60%).
    Descrizione

    ecog performance status

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    adequate renal functions: serum creatinine < 2 times the upper limit of normal (uln).
    Descrizione

    upper limit of normal (sgpt); upper limit of normal (sgot); serum creatinine; renal function; uln

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    adequate hepatic function: serum ast and alt ≤ 3 x uln.
    Descrizione

    hepatic function; serum; ast; uln; alt

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    patients with reproductive potential must use an effective contraceptive method through the study. patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
    Descrizione

    contraceptive; method; study

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    patients receiving any other investigational agents.
    Descrizione

    other; agents

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0013230 (Investigational New Drugs)
    symptomatic cns involvement.
    Descrizione

    cns involvement; symptomatic

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0449389 (CNS involvement status)
    SNOMED
    260766009
    history of pancreatitis or active alcohol abuse.
    Descrizione

    alcohol abuse; pancreatitis; active

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0085762 (Alcohol abuse)
    SNOMED
    15167005
    LOINC
    LP36309-0
    UMLS CUI [2]
    C0030305 (Pancreatitis)
    SNOMED
    75694006
    LOINC
    LA15860-2
    histologic diagnosis of fab m3 aml.
    Descrizione

    diagnosis; fab

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023487 (Acute Promyelocytic Leukemia)
    SNOMED
    110004001
    life expectancy of less than 1 month.
    Descrizione

    life expectancy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    patient receives myelotarg (ozogamicin gemtuzumab).
    Descrizione

    Mylotarg

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0876099 (Mylotarg)
    use of hematopoietic growth factors such as g-csf within 1 week prior to treatment initiation.
    Descrizione

    growth factors; treatment; g-csf; week

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0079490 (Hematopoietic Cell Growth Factors)
    pregnant or lactating females.
    Descrizione

    pregnant or lactating

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    patient has known human immunodeficiency virus (hiv) infection or known hiv-related malignancy; patient has active hepatitis a, b or c infection.
    Descrizione

    human immunodeficiency virus; active hepatitis; hepatitis a; malignancy; infection; related; hiv

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [2]
    C0019159 (Hepatitis A)
    SNOMED
    40468003
    UMLS CUI [3]
    C0348211 (HIV disease resulting in other malignant neoplasms of lymphoid, hematopoietic and related tissue)
    active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
    Descrizione

    systemic infection; life threatening; investigator; treatment; clinical; disease; severe; active; entry; time

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0243026 (Sepsis)
    SNOMED
    91302008
    LOINC
    LA10591-8
    UMLS CUI [2]
    C1517874 (Life Threatening Adverse Event)
    the patient has had congestive heart failure - new york heart association (chf-nyha) grade ii or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the investigator, could put the patient at risk of clinically relevant arrhythmia.
    Descrizione

    new york heart association classification; congestive heart failure; myocardial infarction; cardiac disorder; investigator; arrhythmia; grade; last; chf

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0018802 (Congestive heart failure)
    SNOMED
    42343007
    LOINC
    MTHU020787
    UMLS CUI [2]
    C0027051 (Myocardial Infarction)
    SNOMED
    22298006
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01010373

    1 moduli
    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    myelodysplastic syndrome; bone marrow; diagnosis; aspiration; confirmed; other; primary; fab
    Item
    confirmed diagnosis of primary aml or aml transformed myelodysplastic syndrome (mds) with fab classification other than m3 as proven by bone marrow aspiration.
    boolean
    C3463824 (UMLS CUI [1])
    C0023467 (UMLS CUI [2])
    age
    Item
    age ≥60 years.
    boolean
    C0001779 (UMLS CUI [1])
    ecog performance status
    Item
    ecog performance status of 0-2 (karnofsky >60%).
    boolean
    C1520224 (UMLS CUI [1])
    upper limit of normal (sgpt); upper limit of normal (sgot); serum creatinine; renal function; uln
    Item
    adequate renal functions: serum creatinine < 2 times the upper limit of normal (uln).
    boolean
    C0232804 (UMLS CUI [1])
    hepatic function; serum; ast; uln; alt
    Item
    adequate hepatic function: serum ast and alt ≤ 3 x uln.
    boolean
    C0232741 (UMLS CUI [1])
    contraceptive; method; study
    Item
    patients with reproductive potential must use an effective contraceptive method through the study. patients must receive contraceptive and/or fertility counseling prior to entering the study, i.e., information on sperm banking, etc.
    boolean
    C0700589 (UMLS CUI [1])
    other; agents
    Item
    patients receiving any other investigational agents.
    boolean
    C0013230 (UMLS CUI [1])
    cns involvement; symptomatic
    Item
    symptomatic cns involvement.
    boolean
    C0449389 (UMLS CUI [1])
    alcohol abuse; pancreatitis; active
    Item
    history of pancreatitis or active alcohol abuse.
    boolean
    C0085762 (UMLS CUI [1])
    C0030305 (UMLS CUI [2])
    diagnosis; fab
    Item
    histologic diagnosis of fab m3 aml.
    boolean
    C0023487 (UMLS CUI [1])
    life expectancy
    Item
    life expectancy of less than 1 month.
    boolean
    C0023671 (UMLS CUI [1])
    Mylotarg
    Item
    patient receives myelotarg (ozogamicin gemtuzumab).
    boolean
    C0876099 (UMLS CUI [1])
    growth factors; treatment; g-csf; week
    Item
    use of hematopoietic growth factors such as g-csf within 1 week prior to treatment initiation.
    boolean
    C0079490 (UMLS CUI [1])
    pregnant or lactating
    Item
    pregnant or lactating females.
    boolean
    C0549206 (UMLS CUI [1])
    human immunodeficiency virus; active hepatitis; hepatitis a; malignancy; infection; related; hiv
    Item
    patient has known human immunodeficiency virus (hiv) infection or known hiv-related malignancy; patient has active hepatitis a, b or c infection.
    boolean
    C0019682 (UMLS CUI [1])
    C0019159 (UMLS CUI [2])
    C0348211 (UMLS CUI [3])
    systemic infection; life threatening; investigator; treatment; clinical; disease; severe; active; entry; time
    Item
    active, uncontrolled, systemic infection considered opportunistic, life threatening, or of clinical significance at the time of treatment, or any severe concurrent disease which, in the opinion of the investigator, would make the patient inappropriate for trial entry.
    boolean
    C0243026 (UMLS CUI [1])
    C1517874 (UMLS CUI [2])
    new york heart association classification; congestive heart failure; myocardial infarction; cardiac disorder; investigator; arrhythmia; grade; last; chf
    Item
    the patient has had congestive heart failure - new york heart association (chf-nyha) grade ii or higher, and/or myocardial infarction within the last 12 months, or any cardiac disorder which, in the opinion of the investigator, could put the patient at risk of clinically relevant arrhythmia.
    boolean
    C0018802 (UMLS CUI [1])
    C0027051 (UMLS CUI [2])
    Ritorna all'inizio della pagina 

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