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ID

13019

Beschreibung

Cytarabine and UCN-01 in Treating Patients With Refractory or Relapsed Acute Myelogenous Leukemia or Myelodysplastic Syndrome; ODM derived from: https://clinicaltrials.gov/show/NCT00004263

Link

https://clinicaltrials.gov/show/NCT00004263

Stichworte

  1. 12.01.16 12.01.16 -
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CC BY-NC 3.0

Hochgeladen am

12. Januar 2016

DOI

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Creative Commons BY-NC 3.0

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    Eligibility Leukemia NCT00004263

    Eligibility Leukemia NCT00004263

    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00004263
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. 1. patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (raeb or raeb-t).
    Beschreibung

    relapsed acute myelogenous leukemia, or myelodysplastic syndromes

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    2. 2. performance status of =< 2
    Beschreibung

    performance status

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1518965
    3. 3. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol for each participating institution.
    Beschreibung

    informed consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    4. 4. patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
    Beschreibung

    chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    5. 5. bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
    Beschreibung

    bilirubin and creatinine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201976
    6. 6. patients must have relapsed or failed to respond after high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy.
    Beschreibung

    high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0010711
    7. 7. corrected dlco >50%.
    Beschreibung

    DLCO

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1516251
    8. 8. patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.
    Beschreibung

    cardiac risk factors

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C2024776
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. 1. the anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. therefore, pregnant and nursing females will be excluded. patients of childbearing potential should practice effective methods of contraception.
    Beschreibung

    pregnancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0700589
    2. 2. patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
    Beschreibung

    allogeneic marrow transplant

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0149615
    3. 3. patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.
    Beschreibung

    comorbidity or radiotherapy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C1522449

    Ähnliche Modelle

    Eligibility Leukemia NCT00004263

    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00004263
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    relapsed acute myelogenous leukemia, or myelodysplastic syndromes
    Item
    1. 1. patients with refractory or relapsed acute myelogenous leukemia, or myelodysplastic syndromes (raeb or raeb-t).
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    performance status
    Item
    2. 2. performance status of =< 2
    boolean
    C1518965 (UMLS CUI [1])
    informed consent
    Item
    3. 3. signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital. the only acceptable consent form is the one attached at the end of this protocol for each participating institution.
    boolean
    C0021430 (UMLS CUI [1])
    chemotherapy
    Item
    4. 4. patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease.
    boolean
    C0392920 (UMLS CUI [1])
    bilirubin and creatinine
    Item
    5. 5. bilirubin and creatinine (or creatinine clearance) should be within institutional normal limits.
    boolean
    C1278039 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy
    Item
    6. 6. patients must have relapsed or failed to respond after high-dose ara-c-based (>=1g/m2/day x 3 days) chemotherapy.
    boolean
    C0010711 (UMLS CUI [1])
    DLCO
    Item
    7. 7. corrected dlco >50%.
    boolean
    C1516251 (UMLS CUI [1])
    cardiac risk factors
    Item
    8. 8. patients with >=3 cardiac risk factors (smoking, hypertension, family history of coronary artery disease, diabetes mellitus, hypercholesterolemia) should have a nuclear medicine stress test.
    boolean
    C2024776 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    pregnancy
    Item
    1. 1. the anti-proliferative activity of the experimental drug may be harmful to the developing fetus or nursing infant. therefore, pregnant and nursing females will be excluded. patients of childbearing potential should practice effective methods of contraception.
    boolean
    C0032961 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    allogeneic marrow transplant
    Item
    2. 2. patients who are eligible for allogeneic marrow transplant and who have a donor will be offered transplant.
    boolean
    C0149615 (UMLS CUI [1])
    comorbidity or radiotherapy
    Item
    3. 3. patients with existing pulmonary diseases, history of coronary artery disease or who have received radiotherapy to the mediastinum.
    boolean
    C0009488 (UMLS CUI [1])
    C1522449 (UMLS CUI [2])

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