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ID

41094

Beschrijving

Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01786343

Link

https://clinicaltrials.gov/show/NCT01786343

Trefwoorden

Versies (1)
  1. 23-06-20 23-06-20 -
Houder van rechten

See clinicaltrials.gov

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23 juni 2020

DOI

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Creative Commons BY 4.0
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    Eligibility Leukemia NCT01786343

    Engels

    Eligibility Leukemia NCT01786343

    1 Formulieren  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT01786343
    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients with previously untreated aml (by the who criteria, i.e. >/= 20% blasts) prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
    Beschrijving

    AML Untreated | Blasts Percentage | Biological treatment MYELODYSPLASTIC SYNDROME | Growth Factor | Targeted Therapy MYELODYSPLASTIC SYNDROME | Exception Hypomethylation Therapy | Exception Azacitidine | Exception Decitabine | Therapeutic procedure Discontinued | Toxicity Due to Therapeutic procedure | Patient recovered | Exception Rapid disease progression | Hydroxyurea allowed | Cytarabine Dose allowed

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0332155
    UMLS CUI [2,1]
    C0368761
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [3,1]
    C1531518
    UMLS CUI [3,2]
    C3463824
    UMLS CUI [4]
    C0018284
    UMLS CUI [5,1]
    C2985566
    UMLS CUI [5,2]
    C3463824
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C4054751
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0004475
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0049065
    UMLS CUI [9,1]
    C0087111
    UMLS CUI [9,2]
    C1444662
    UMLS CUI [10,1]
    C0600688
    UMLS CUI [10,2]
    C0678226
    UMLS CUI [10,3]
    C0087111
    UMLS CUI [11]
    C1115804
    UMLS CUI [12,1]
    C1705847
    UMLS CUI [12,2]
    C1834700
    UMLS CUI [13,1]
    C0020402
    UMLS CUI [13,2]
    C0683607
    UMLS CUI [14,1]
    C0010711
    UMLS CUI [14,2]
    C0178602
    UMLS CUI [14,3]
    C0683607
    2. patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by kantarjian's score (appendix d) patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    3. performance 0-3 (ecog).
    Beschrijving

    ECOG performance status

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    4. adequate liver function (total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).
    Beschrijving

    Liver function | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Leukemia | Exception Due to Gilbert Disease | Renal function | Creatinine measurement, serum

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0678226
    UMLS CUI [3,3]
    C0019054
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0678226
    UMLS CUI [4,3]
    C0023418
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0678226
    UMLS CUI [5,3]
    C0017551
    UMLS CUI [6]
    C0232804
    UMLS CUI [7]
    C0201976
    5. signed informed consent
    Beschrijving

    Informed Consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. nursing and pregnant females. female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. negative urine pregnancy test (women of childbearing potential)
    Beschrijving

    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0006147
    UMLS CUI [2]
    C0032961
    UMLS CUI [3,1]
    C3831118
    UMLS CUI [3,2]
    C0700589
    UMLS CUI [4,1]
    C0079399
    UMLS CUI [4,2]
    C0700589
    UMLS CUI [5,1]
    C0004764
    UMLS CUI [5,2]
    C0205173
    UMLS CUI [6,1]
    C3831118
    UMLS CUI [6,2]
    C0430057
    2. active and uncontrolled infections.
    Beschrijving

    Communicable Disease Uncontrolled

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
    Beschrijving

    Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cancer Other Requirement Chemotherapy | Cancer Other Requirement Therapeutic radiology procedure | Exception Skin carcinoma | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [2]
    C0742758
    UMLS CUI [3]
    C0002965
    UMLS CUI [4,1]
    C1707251
    UMLS CUI [4,2]
    C1514873
    UMLS CUI [4,3]
    C0392920
    UMLS CUI [5,1]
    C1707251
    UMLS CUI [5,2]
    C1514873
    UMLS CUI [5,3]
    C1522449
    UMLS CUI [6,1]
    C1705847
    UMLS CUI [6,2]
    C0699893
    UMLS CUI [7,1]
    C0004936
    UMLS CUI [7,2]
    C0439801
    UMLS CUI [7,3]
    C0525058
    UMLS CUI [8,1]
    C0748872
    UMLS CUI [8,2]
    C0439801
    UMLS CUI [8,3]
    C0525058
    Terug naar het begin van de pagina

    Similar models

    Eligibility Leukemia NCT01786343

    1 Formulieren
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT01786343
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    AML Untreated | Blasts Percentage | Biological treatment MYELODYSPLASTIC SYNDROME | Growth Factor | Targeted Therapy MYELODYSPLASTIC SYNDROME | Exception Hypomethylation Therapy | Exception Azacitidine | Exception Decitabine | Therapeutic procedure Discontinued | Toxicity Due to Therapeutic procedure | Patient recovered | Exception Rapid disease progression | Hydroxyurea allowed | Cytarabine Dose allowed
    Item
    1. patients with previously untreated aml (by the who criteria, i.e. >/= 20% blasts) prior biologic therapies (such as growth factors) and targeted therapies administered for the treatment of prior myelodysplastic syndrome are allowed, with the exception of hypomethylating agents 5-azacytidine or decitabine. patients must have been off such therapy for 1 week prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. hydroxyurea, and a single dose of cytarabine up to 3 g/m2, is permitted for control of counts prior to treatment.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0332155 (UMLS CUI [1,2])
    C0368761 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C1531518 (UMLS CUI [3,1])
    C3463824 (UMLS CUI [3,2])
    C0018284 (UMLS CUI [4])
    C2985566 (UMLS CUI [5,1])
    C3463824 (UMLS CUI [5,2])
    C1705847 (UMLS CUI [6,1])
    C4054751 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0004475 (UMLS CUI [7,2])
    C1705847 (UMLS CUI [8,1])
    C0049065 (UMLS CUI [8,2])
    C0087111 (UMLS CUI [9,1])
    C1444662 (UMLS CUI [9,2])
    C0600688 (UMLS CUI [10,1])
    C0678226 (UMLS CUI [10,2])
    C0087111 (UMLS CUI [10,3])
    C1115804 (UMLS CUI [11])
    C1705847 (UMLS CUI [12,1])
    C1834700 (UMLS CUI [12,2])
    C0020402 (UMLS CUI [13,1])
    C0683607 (UMLS CUI [13,2])
    C0010711 (UMLS CUI [14,1])
    C0178602 (UMLS CUI [14,2])
    C0683607 (UMLS CUI [14,3])
    Age
    Item
    2. patients >/= 60 are eligible if not a candidate for standard cytarabine plus anthracycline chemotherapy as determined by kantarjian's score (appendix d) patients younger than 60 may also be included if felt not to be a candidate for intensive anthracycline plus cytarabine based chemotherapy.
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    3. performance 0-3 (ecog).
    boolean
    C1520224 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Exception Due to Hemolysis | Exception Due to Leukemia | Exception Due to Gilbert Disease | Renal function | Creatinine measurement, serum
    Item
    4. adequate liver function (total bilirubin of < 2 mg/dl) unless due to hemolysis, leukemia organ infiltration or gilbert's syndrome and renal function (creatinine < 2.5 mg/dl).
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0678226 (UMLS CUI [3,2])
    C0019054 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0678226 (UMLS CUI [4,2])
    C0023418 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0678226 (UMLS CUI [5,2])
    C0017551 (UMLS CUI [5,3])
    C0232804 (UMLS CUI [6])
    C0201976 (UMLS CUI [7])
    Informed Consent
    Item
    5. signed informed consent
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Breast Feeding | Pregnancy | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative
    Item
    1. nursing and pregnant females. female patients of childbearing potential and male patients should practice effective methods of contraception such as double barrier method. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. negative urine pregnancy test (women of childbearing potential)
    boolean
    C0006147 (UMLS CUI [1])
    C0032961 (UMLS CUI [2])
    C3831118 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    C0079399 (UMLS CUI [4,1])
    C0700589 (UMLS CUI [4,2])
    C0004764 (UMLS CUI [5,1])
    C0205173 (UMLS CUI [5,2])
    C3831118 (UMLS CUI [6,1])
    C0430057 (UMLS CUI [6,2])
    Communicable Disease Uncontrolled
    Item
    2. active and uncontrolled infections.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Comorbidity Uncontrolled | Symptomatic congestive heart failure | Angina, Unstable | Cancer Other Requirement Chemotherapy | Cancer Other Requirement Therapeutic radiology procedure | Exception Skin carcinoma | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
    Item
    3. uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, active significant other cancers requiring chemotherapy and/or radiation therapy within past 6 months (excluding non-melanoma skin cancer) or psychiatric illness/social situations that would limit compliance with study requirements.
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0742758 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C1707251 (UMLS CUI [4,1])
    C1514873 (UMLS CUI [4,2])
    C0392920 (UMLS CUI [4,3])
    C1707251 (UMLS CUI [5,1])
    C1514873 (UMLS CUI [5,2])
    C1522449 (UMLS CUI [5,3])
    C1705847 (UMLS CUI [6,1])
    C0699893 (UMLS CUI [6,2])
    C0004936 (UMLS CUI [7,1])
    C0439801 (UMLS CUI [7,2])
    C0525058 (UMLS CUI [7,3])
    C0748872 (UMLS CUI [8,1])
    C0439801 (UMLS CUI [8,2])
    C0525058 (UMLS CUI [8,3])
    Terug naar het begin van de pagina 

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