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ID

21404

Beschreibung

Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00422591

Link

https://clinicaltrials.gov/show/NCT00422591

Stichworte

Versionen (1)
  1. 19.04.17 19.04.17 -
Hochgeladen am

19. April 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Leukemia NCT00422591

    Englisch

    Eligibility Leukemia NCT00422591

    1 Formulare  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00422591
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. diagnosis of 1) aml (who classification definition of >/= 20% blasts). patients with m6 aml with less than 20% blasts are eligible.
    Beschreibung

    Acute Myelocytic Leukemia WHO classification | Acute Myelocytic Leukemia French-American-British Classification | Blast count

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1301142
    UMLS CUI [2,1]
    C0023467
    UMLS CUI [2,2]
    C2984084
    UMLS CUI [3]
    C0523113
    2. patients aged 15 to 75 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusions, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
    Beschreibung

    Age | Chemotherapy naive | Acute Myelocytic Leukemia | Hydrea | Blood Transfusion | Hematopoietic Growth Factors | Vitamins | Pheresis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C0392920
    UMLS CUI [2,2]
    C0919936
    UMLS CUI [3]
    C0023467
    UMLS CUI [4]
    C0591617
    UMLS CUI [5]
    C0005841
    UMLS CUI [6]
    C0079490
    UMLS CUI [7]
    C0042890
    UMLS CUI [8]
    C0005791
    3. ecog ps of 0, 1, 2, or 3 at screening.
    Beschreibung

    ECOG performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
    Beschreibung

    Biochemical finding | Creatinine measurement, serum

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0428132
    UMLS CUI [2]
    C0201976
    total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis - transaminases (sg pt) </= 3x uln
    Beschreibung

    Serum total bilirubin measurement

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    5. ability to understand and provide signed informed consent.
    Beschreibung

    Informed Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. subjects with acute promyelocytic leukemia (apl).
    Beschreibung

    Acute Promyelocytic Leukemia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023487
    2. presence of active systemic infection.
    Beschreibung

    Sepsis

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0243026
    3. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
    Beschreibung

    Comorbidity Interferes with Protocol Compliance | Comorbidity Interferes with Research results

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0521102
    UMLS CUI [1,3]
    C0525058
    UMLS CUI [2,1]
    C0009488
    UMLS CUI [2,2]
    C0521102
    UMLS CUI [2,3]
    C0683954
    4. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
    Beschreibung

    Breast Feeding | Urine pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condoms Partner

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0430059
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [3,3]
    C0558080
    UMLS CUI [4]
    C0009905
    UMLS CUI [5]
    C0021900
    UMLS CUI [6]
    C0042241
    UMLS CUI [7]
    C0036899
    UMLS CUI [8,1]
    C0677582
    UMLS CUI [8,2]
    C0682323
    Zum Seitenanfang zurückkehren

    Ähnliche Modelle

    Eligibility Leukemia NCT00422591

    1 Formulare
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00422591
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Acute Myelocytic Leukemia WHO classification | Acute Myelocytic Leukemia French-American-British Classification | Blast count
    Item
    1. diagnosis of 1) aml (who classification definition of >/= 20% blasts). patients with m6 aml with less than 20% blasts are eligible.
    boolean
    C0023467 (UMLS CUI [1,1])
    C1301142 (UMLS CUI [1,2])
    C0023467 (UMLS CUI [2,1])
    C2984084 (UMLS CUI [2,2])
    C0523113 (UMLS CUI [3])
    Age | Chemotherapy naive | Acute Myelocytic Leukemia | Hydrea | Blood Transfusion | Hematopoietic Growth Factors | Vitamins | Pheresis
    Item
    2. patients aged 15 to 75 years are eligible. patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for aml. they could have received transfusions, hematopoietic growth factors or vitamins. temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
    boolean
    C0001779 (UMLS CUI [1])
    C0392920 (UMLS CUI [2,1])
    C0919936 (UMLS CUI [2,2])
    C0023467 (UMLS CUI [3])
    C0591617 (UMLS CUI [4])
    C0005841 (UMLS CUI [5])
    C0079490 (UMLS CUI [6])
    C0042890 (UMLS CUI [7])
    C0005791 (UMLS CUI [8])
    ECOG performance status
    Item
    3. ecog ps of 0, 1, 2, or 3 at screening.
    boolean
    C1520224 (UMLS CUI [1])
    Biochemical finding | Creatinine measurement, serum
    Item
    4. serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl -
    boolean
    C0428132 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Serum total bilirubin measurement
    Item
    total bilirubin </= 2.0 mg/dl, unless increase is due to hemolysis - transaminases (sg pt) </= 3x uln
    boolean
    C1278039 (UMLS CUI [1])
    Informed Consent
    Item
    5. ability to understand and provide signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Acute Promyelocytic Leukemia
    Item
    1. subjects with acute promyelocytic leukemia (apl).
    boolean
    C0023487 (UMLS CUI [1])
    Sepsis
    Item
    2. presence of active systemic infection.
    boolean
    C0243026 (UMLS CUI [1])
    Comorbidity Interferes with Protocol Compliance | Comorbidity Interferes with Research results
    Item
    3. any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0521102 (UMLS CUI [1,2])
    C0525058 (UMLS CUI [1,3])
    C0009488 (UMLS CUI [2,1])
    C0521102 (UMLS CUI [2,2])
    C0683954 (UMLS CUI [2,3])
    Breast Feeding | Urine pregnancy test positive | Childbearing Potential Contraceptive methods Unwilling | Contraceptives, Oral | Intrauterine Devices | Vaginal contraceptive diaphragm | Sexual Abstinence | Condoms Partner
    Item
    4. nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, iud, diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
    boolean
    C0006147 (UMLS CUI [1])
    C0430059 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0558080 (UMLS CUI [3,3])
    C0009905 (UMLS CUI [4])
    C0021900 (UMLS CUI [5])
    C0042241 (UMLS CUI [6])
    C0036899 (UMLS CUI [7])
    C0677582 (UMLS CUI [8,1])
    C0682323 (UMLS CUI [8,2])
    Zum Seitenanfang zurückkehren 

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