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ID

12803

Beskrivning

CMC-544 in Relapsed Refractory Acute Lymphoblastic Leukemia (ALL); ODM derived from: https://clinicaltrials.gov/show/NCT01134575

Länk

https://clinicaltrials.gov/show/NCT01134575

Nyckelord

  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

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Licens

Creative Commons BY 4.0

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    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    previously treated all (including burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. patients in first relapse will be eligible regardless of the first remission duration. at least 10 patients in salvage 1-2 will be treated to assess anti-all response more precisely.
    Beskrivning

    all recurrent disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023449 (Acute lymphocytic leukemia)
    SNOMED
    91857003
    LOINC
    LA31346-2
    UMLS CUI [2]
    C0277556 (Recurrent disease)
    SNOMED
    58184002
    age 16 years or older. pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
    Beskrivning

    age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    zubrod performance status 0-3.
    Beskrivning

    zubrod performance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C3714786 (Zubrod Performance Status)
    adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
    Beskrivning

    liver and renal function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).
    Beskrivning

    contraception, negative pregnancy test

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0427780 (Pregnancy test negative)
    SNOMED
    250425007
    UMLS CUI [2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
    Beskrivning

    heart failure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0018801 (Heart failure)
    SNOMED
    84114007
    LOINC
    LP269421-6
    patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45 percent are excluded.
    Beskrivning

    ejection fraction reduced

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C4022792 (Reduced ejection fraction)
    patients who receive other chemotherapy. patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (concurrent therapy for central nervous system [cns] prophylaxis or treatment for cns relapse is permitted). treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the principal investigator.
    Beskrivning

    chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    prior allogeneic stem cell transplant in previous 4 months.
    Beskrivning

    allogeneic stem cell transplant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2242529 (Allogeneic Stem Cell Transplantation)
    peripheral lymphoblasts > 50 x 10^9/l.
    Beskrivning

    peripheral lymphoblasts

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1167770 (Lymphoblast count)
    pregnant and breast-feeding patients are excluded.
    Beskrivning

    pregnant or breastfeeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    patients with known hepatitis b are excluded.
    Beskrivning

    hepatitis b positivity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0856706 (Hepatitis B positive)

    Similar models

    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    all recurrent disease
    Item
    previously treated all (including burkitt's lymphoma and lymphoblastic lymphoma) in relapse or primary refractory. patients in first relapse will be eligible regardless of the first remission duration. at least 10 patients in salvage 1-2 will be treated to assess anti-all response more precisely.
    boolean
    C0023449 (UMLS CUI [1])
    C0277556 (UMLS CUI [2])
    age
    Item
    age 16 years or older. pediatric patients (<16 years old) will be allowed into the study after safety is established, that is at least 10 adult patients having received 1 or more cycles each.
    boolean
    C0001779 (UMLS CUI [1])
    zubrod performance
    Item
    zubrod performance status 0-3.
    boolean
    C3714786 (UMLS CUI [1])
    liver and renal function
    Item
    adequate liver function (bilirubin </= 1.5 mg/dl and sgpt or sgot </= 3 x upper limit of normal [uln], unless considered due to tumor), and renal function (creatinine </= 2 mg/dl). even if organ function abnormalities are considered due to tumor, the upper limit for bilirubin is </= 2.0 mg/dl and creatinine </= 3 mg/dl.
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    contraception, negative pregnancy test
    Item
    male and female patients who are of childbearing potential agree to use an effective barrier method of birth control (e.g., latex condom, diaphragm, cervical cap, etc.) to avoid pregnancy. female patients need a negative serum or urine pregnancy test within 14 days of study start (applies only if patient is of childbearing potential. non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized).
    boolean
    C0427780 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    heart failure
    Item
    patient with active heart disease (nyha class >/= 3 as assessed by history and physical examination).
    boolean
    C0018801 (UMLS CUI [1])
    ejection fraction reduced
    Item
    patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45 percent are excluded.
    boolean
    C4022792 (UMLS CUI [1])
    chemotherapy
    Item
    patients who receive other chemotherapy. patients must have been off previous therapy for >/= 2 weeks and must have recovered from acute toxicity (to grade 1 or less) of all previous therapy prior to enrollment (consent signing). (concurrent therapy for central nervous system [cns] prophylaxis or treatment for cns relapse is permitted). treatment may start earlier if necessitated by the patient's medical condition (e.g. rapidly progressive disease) following discussion with the principal investigator.
    boolean
    C0392920 (UMLS CUI [1])
    allogeneic stem cell transplant
    Item
    prior allogeneic stem cell transplant in previous 4 months.
    boolean
    C2242529 (UMLS CUI [1])
    peripheral lymphoblasts
    Item
    peripheral lymphoblasts > 50 x 10^9/l.
    boolean
    C1167770 (UMLS CUI [1])
    pregnant or breastfeeding
    Item
    pregnant and breast-feeding patients are excluded.
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    hepatitis b positivity
    Item
    patients with known hepatitis b are excluded.
    boolean
    C0856706 (UMLS CUI [1])

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