0 Evaluaciones

ID

12803

Descripción

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

Link

https://clinicaltrials.gov/show/NCT01134575

Palabras clave

  1. 21/12/15 21/12/15 -
Subido en

21 de diciembre de 2015

DOI

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Licencia

Creative Commons BY 4.0

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    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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.
    Descripción

    all recurrent disease

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023449
    UMLS CUI [2]
    C0277556
    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.
    Descripción

    age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    zubrod performance status 0-3.
    Descripción

    zubrod performance

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    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.
    Descripción

    liver and renal function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0232804
    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).
    Descripción

    contraception, negative pregnancy test

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0427780
    UMLS CUI [2]
    C0700589
    Exclusion Criteria
    Descripción

    Exclusion Criteria

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

    heart failure

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0018801
    patients with a cardiac ejection fraction (as measured by either muga or echocardiogram) < 45 percent are excluded.
    Descripción

    ejection fraction reduced

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C4022792
    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.
    Descripción

    chemotherapy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0392920
    prior allogeneic stem cell transplant in previous 4 months.
    Descripción

    allogeneic stem cell transplant

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C2242529
    peripheral lymphoblasts > 50 x 10^9/l.
    Descripción

    peripheral lymphoblasts

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1167770
    pregnant and breast-feeding patients are excluded.
    Descripción

    pregnant or breastfeeding

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C0006147
    patients with known hepatitis b are excluded.
    Descripción

    hepatitis b positivity

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0856706

    Similar models

    Eligibility Acute Lymphoblastic Leukemia NCT01134575

    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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