0 Ratings
ID

44778

Description

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

Link

https://clinicaltrials.gov/show/NCT01010373

Keywords

Versions (3)
  1. 9/1/15 9/1/15 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
  3. 11/18/21 11/18/21 -
Copyright Holder

BioMAS Ltd

Uploaded on

November 18, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Acute Myeloid Leukemia NCT01010373

    English

    Eligibility Acute Myeloid Leukemia NCT01010373

    1 forms  
    Inclusion Criteria
    Description

    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.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3463824
    UMLS CUI [2]
    C0023467
    age ≥60 years.
    Description

    age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    ecog performance status of 0-2 (karnofsky >60%).
    Description

    ecog performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    adequate renal functions: serum creatinine < 2 times the upper limit of normal (uln).
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    adequate hepatic function: serum ast and alt ≤ 3 x uln.
    Description

    hepatic function; serum; ast; uln; alt

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    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.
    Description

    contraceptive; method; study

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    Exclusion Criteria
    Description

    Exclusion Criteria

    patients receiving any other investigational agents.
    Description

    other; agents

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013230
    symptomatic cns involvement.
    Description

    cns involvement; symptomatic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0449389
    history of pancreatitis or active alcohol abuse.
    Description

    alcohol abuse; pancreatitis; active

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085762
    UMLS CUI [2]
    C0030305
    histologic diagnosis of fab m3 aml.
    Description

    diagnosis; fab

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    life expectancy of less than 1 month.
    Description

    life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    patient receives myelotarg (ozogamicin gemtuzumab).
    Description

    Mylotarg

    Data type

    boolean

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

    growth factors; treatment; g-csf; week

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079490
    pregnant or lactating females.
    Description

    pregnant or lactating

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    patient has known human immunodeficiency virus (hiv) infection or known hiv-related malignancy; patient has active hepatitis a, b or c infection.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0019159
    UMLS CUI [3]
    C0348211
    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.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0243026
    UMLS CUI [2]
    C1517874
    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.
    Description

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

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0018802
    UMLS CUI [2]
    C0027051
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT01010373

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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