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ID

14567

Descrizione

Lenalidomide and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01904643

collegamento

https://clinicaltrials.gov/show/NCT01904643

Keywords

  1. 21/04/16 21/04/16 -
Caricato su

21 aprile 2016

DOI

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Licenza

Creative Commons BY 4.0

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    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

    Inclusion Criteria
    Descrizione

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    patients eligible include those with diagnosis of aml other than acute promyelocytic leukemia by world health organization (who) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy
    Descrizione

    aml

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    eastern cooperative oncology group (ecog) performance status 0-2
    Descrizione

    eastern cooperative oncology group (ecog)

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1520224 (ECOG performance status)
    SNOMED
    423740007
    serum creatinine =< 1.5 mg/dl; if serum creatinine > 1.5 mg/dl, then the estimated glomerular filtrate rate (gfr) must be > 60ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation
    Descrizione

    serum creatinine

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    serum bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is considered to be secondary to gilbert's syndrome, hemolysis, or hepatic infiltration by aml
    Descrizione

    serum bilirubin

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    aspartate transaminase (ast)/alanine transaminase (alt) =< 2.5 x uln
    Descrizione

    aspartate transaminase

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0004002 (Aspartate Transaminase)
    SNOMED
    26091008
    alkaline phosphatase =< 2.5 x uln
    Descrizione

    alkaline phosphatase

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0201850 (Alkaline phosphatase measurement)
    SNOMED
    88810008
    all study participants must be registered into the mandatory revlimid assistance (revassist) program, and be willing and able to comply with the requirements of revassist
    Descrizione

    Revlimid

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1135145 (Revlimid)
    females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revassist) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide; fcbp must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy
    Descrizione

    negative serum or urine pregnancy test

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0430061 (Serum pregnancy test negative)
    SNOMED
    166435006
    UMLS CUI [2]
    C0430057 (Urine pregnancy test negative)
    SNOMED
    167254001
    Exclusion Criteria
    Descrizione

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
    Descrizione

    Concomitant Therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1707479 (Concomitant Therapy)
    patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient's last prior therapy before initiation of treatment on clinical trial
    Descrizione

    lenalidomide therapy

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C1144149 (lenalidomide)
    SNOMED
    421471009
    have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment
    Descrizione

    concurrent disease

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009488 (Comorbidity)
    have significant, uncontrolled active infection
    Descrizione

    active infection

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    pregnant or nursing patients will be excluded from the study
    Descrizione

    pregnant or nursing patients

    Tipo di dati

    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
    known human immunodeficiency virus (hiv) infection
    Descrizione

    hiv

    Tipo di dati

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1

    Similar models

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

    Name
    genere
    Description | Question | Decode (Coded Value)
    Tipo di dati
    Alias
    Item Group
    C1512693 (UMLS CUI)
    aml
    Item
    patients eligible include those with diagnosis of aml other than acute promyelocytic leukemia by world health organization (who) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy
    boolean
    C0023467 (UMLS CUI [1])
    eastern cooperative oncology group (ecog)
    Item
    eastern cooperative oncology group (ecog) performance status 0-2
    boolean
    C1520224 (UMLS CUI [1])
    serum creatinine
    Item
    serum creatinine =< 1.5 mg/dl; if serum creatinine > 1.5 mg/dl, then the estimated glomerular filtrate rate (gfr) must be > 60ml/min/1.73m^2 as calculated by the modification of diet in renal disease equation
    boolean
    C0201976 (UMLS CUI [1])
    serum bilirubin
    Item
    serum bilirubin =< 1.5 x upper limit of normal (uln) unless elevation is considered to be secondary to gilbert's syndrome, hemolysis, or hepatic infiltration by aml
    boolean
    C1278039 (UMLS CUI [1])
    aspartate transaminase
    Item
    aspartate transaminase (ast)/alanine transaminase (alt) =< 2.5 x uln
    boolean
    C0004002 (UMLS CUI [1])
    alkaline phosphatase
    Item
    alkaline phosphatase =< 2.5 x uln
    boolean
    C0201850 (UMLS CUI [1])
    Revlimid
    Item
    all study participants must be registered into the mandatory revlimid assistance (revassist) program, and be willing and able to comply with the requirements of revassist
    boolean
    C1135145 (UMLS CUI [1])
    negative serum or urine pregnancy test
    Item
    females of childbearing potential (fcbp) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 miu/ml within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for cycle 1 (prescriptions must be filled within 7 days as required by revassist) and must either commit to continued abstinence from heterosexual intercourse or begin two acceptable methods of birth control, one highly effective method and one additional effective method at the same time, at least 28 days before she starts taking lenalidomide; fcbp must also agree to ongoing pregnancy testing; men must agree to use a latex condom during sexual contact with a fcbp even if they have had a successful vasectomy
    boolean
    C0430061 (UMLS CUI [1])
    C0430057 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Concomitant Therapy
    Item
    patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
    boolean
    C1707479 (UMLS CUI [1])
    lenalidomide therapy
    Item
    patients who have received prior lenalidomide therapy are not eligible for this study; further there should be at least a 14-day window from the patient's last prior therapy before initiation of treatment on clinical trial
    boolean
    C1144149 (UMLS CUI [1])
    concurrent disease
    Item
    have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment
    boolean
    C0009488 (UMLS CUI [1])
    active infection
    Item
    have significant, uncontrolled active infection
    boolean
    C0009450 (UMLS CUI [1])
    pregnant or nursing patients
    Item
    pregnant or nursing patients will be excluded from the study
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    hiv
    Item
    known human immunodeficiency virus (hiv) infection
    boolean
    C0019682 (UMLS CUI [1])

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