ID

20131

Description

5-Azacytidine (Azacytidine; Vidaza) in Chronic Lymphocytic Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT00413478

Link

https://clinicaltrials.gov/show/NCT00413478

Keywords

Versions (1)
  1. 2/8/17 2/8/17 -
Uploaded on

February 8, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Chronic Lymphocytic Leukemia NCT00413478

    English

    Eligibility Chronic Lymphocytic Leukemia NCT00413478

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with chronic lymphocytic leukemia (cll), prolymphocytic leukemia, richter's transformation or t-pll who have previously been treated with fludarabine or another regime are eligible.
    Description

    Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | T-Cell Prolymphocytic Leukemia | fludarabine | Patients Treated

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023434
    UMLS CUI [2]
    C0023486
    UMLS CUI [3]
    C0349631
    UMLS CUI [4]
    C2363142
    UMLS CUI [5]
    C0059985
    UMLS CUI [6,1]
    C0030705
    UMLS CUI [6,2]
    C1522326
    2. patients with histologically or cytologically confirmed richter's transformation.
    Description

    Richter's syndrome

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0349631
    3. serum glutamic-oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) less than x 2 normal levels.
    Description

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    4. women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
    Description

    Childbearing Potential Pregnancy test negative | Azacitidine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0427780
    UMLS CUI [2]
    C0004475
    5. women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
    Description

    Childbearing Potential Agreement Pregnancy Absent | Gender Agreement Reproduction Absent | Azacitidine

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0680240
    UMLS CUI [1,3]
    C0032961
    UMLS CUI [1,4]
    C0332197
    UMLS CUI [2,1]
    C0079399
    UMLS CUI [2,2]
    C0680240
    UMLS CUI [2,3]
    C0035150
    UMLS CUI [2,4]
    C0332197
    UMLS CUI [3]
    C0004475
    6. performance 0-2 (ecog). adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded).
    Description

    ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification Exclusion

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    UMLS CUI [2]
    C0232741
    UMLS CUI [3]
    C1278039
    UMLS CUI [4]
    C0232804
    UMLS CUI [5]
    C0201976
    UMLS CUI [6]
    C0232164
    UMLS CUI [7,1]
    C0018799
    UMLS CUI [7,2]
    C1275491
    UMLS CUI [7,3]
    C2828389
    7. signed informed consent.
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. breast feeding or pregnant females. patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    Description

    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    2. known or suspected hypersensitivity to azacytidine or mannitol.
    Description

    Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0004475
    UMLS CUI [2]
    C0571922
    UMLS CUI [3,1]
    C0020517
    UMLS CUI [3,2]
    C0750491
    UMLS CUI [3,3]
    C0004475
    UMLS CUI [4,1]
    C0571922
    UMLS CUI [4,2]
    C0750491
    3. active and uncontrolled infections.
    Description

    Communicable Diseases Uncontrolled

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    4. patients with advanced malignant hepatic tumors.
    Description

    Malignant neoplasm of liver Advanced

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0345904
    UMLS CUI [1,2]
    C0205179
    5. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
    Description

    Illness Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0221423
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0742758
    UMLS CUI [3]
    C0002965
    UMLS CUI [4,1]
    C0004936
    UMLS CUI [4,2]
    C0525058
    UMLS CUI [4,3]
    C0439801
    UMLS CUI [5,1]
    C0748872
    UMLS CUI [5,2]
    C0525058
    UMLS CUI [5,3]
    C0439801
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    Eligibility Chronic Lymphocytic Leukemia NCT00413478

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Chronic Lymphocytic Leukemia | Prolymphocytic Leukemia | Richter's syndrome | T-Cell Prolymphocytic Leukemia | fludarabine | Patients Treated
    Item
    1. patients with chronic lymphocytic leukemia (cll), prolymphocytic leukemia, richter's transformation or t-pll who have previously been treated with fludarabine or another regime are eligible.
    boolean
    C0023434 (UMLS CUI [1])
    C0023486 (UMLS CUI [2])
    C0349631 (UMLS CUI [3])
    C2363142 (UMLS CUI [4])
    C0059985 (UMLS CUI [5])
    C0030705 (UMLS CUI [6,1])
    C1522326 (UMLS CUI [6,2])
    Richter's syndrome
    Item
    2. patients with histologically or cytologically confirmed richter's transformation.
    boolean
    C0349631 (UMLS CUI [1])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement
    Item
    3. serum glutamic-oxaloacetic transaminase (sgot) or serum glutamic-pyruvic transaminase (sgpt) less than x 2 normal levels.
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    Childbearing Potential Pregnancy test negative | Azacitidine
    Item
    4. women of childbearing potential who have a negative pregnancy test prior to azacytidine treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0427780 (UMLS CUI [1,2])
    C0004475 (UMLS CUI [2])
    Childbearing Potential Agreement Pregnancy Absent | Gender Agreement Reproduction Absent | Azacitidine
    Item
    5. women of childbearing potential who agreed not to become pregnant and men agreed not to father a child while on azacytidine treatment.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0680240 (UMLS CUI [1,2])
    C0032961 (UMLS CUI [1,3])
    C0332197 (UMLS CUI [1,4])
    C0079399 (UMLS CUI [2,1])
    C0680240 (UMLS CUI [2,2])
    C0035150 (UMLS CUI [2,3])
    C0332197 (UMLS CUI [2,4])
    C0004475 (UMLS CUI [3])
    ECOG performance status | Liver function | Serum total bilirubin measurement | Renal function | Creatinine measurement, serum | Cardiac function | Heart Disease New York Heart Association Classification Exclusion
    Item
    6. performance 0-2 (ecog). adequate liver function (bilirubin of less than2mg/dl) and renal function (creatinine less than 2mg/dl). adequate cardiac functions (nyha cardiac iii-iv excluded).
    boolean
    C1520224 (UMLS CUI [1])
    C0232741 (UMLS CUI [2])
    C1278039 (UMLS CUI [3])
    C0232804 (UMLS CUI [4])
    C0201976 (UMLS CUI [5])
    C0232164 (UMLS CUI [6])
    C0018799 (UMLS CUI [7,1])
    C1275491 (UMLS CUI [7,2])
    C2828389 (UMLS CUI [7,3])
    Informed Consent
    Item
    7. signed informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods
    Item
    1. breast feeding or pregnant females. patients of (male and female) childbearing potential should practice effective methods of contraception; otherwise, they will be excluded. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    Hypersensitivity Azacitidine | Mannitol allergy | Hypersensitivity Suspected Azacitidine | Mannitol allergy Suspected
    Item
    2. known or suspected hypersensitivity to azacytidine or mannitol.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0004475 (UMLS CUI [1,2])
    C0571922 (UMLS CUI [2])
    C0020517 (UMLS CUI [3,1])
    C0750491 (UMLS CUI [3,2])
    C0004475 (UMLS CUI [3,3])
    C0571922 (UMLS CUI [4,1])
    C0750491 (UMLS CUI [4,2])
    Communicable Diseases Uncontrolled
    Item
    3. active and uncontrolled infections.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Malignant neoplasm of liver Advanced
    Item
    4. patients with advanced malignant hepatic tumors.
    boolean
    C0345904 (UMLS CUI [1,1])
    C0205179 (UMLS CUI [1,2])
    Illness Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Mental disorder Protocol Compliance Limited | Social situation Protocol Compliance Limited
    Item
    5. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
    boolean
    C0221423 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0742758 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0004936 (UMLS CUI [4,1])
    C0525058 (UMLS CUI [4,2])
    C0439801 (UMLS CUI [4,3])
    C0748872 (UMLS CUI [5,1])
    C0525058 (UMLS CUI [5,2])
    C0439801 (UMLS CUI [5,3])
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