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ID

14567

Description

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

Link

https://clinicaltrials.gov/show/NCT01904643

Keywords

  1. 4/21/16 4/21/16 -
Uploaded on

April 21, 2016

DOI

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License

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
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    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
    Description

    aml

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    eastern cooperative oncology group (ecog) performance status 0-2
    Description

    eastern cooperative oncology group (ecog)

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    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
    Description

    serum creatinine

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    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
    Description

    serum bilirubin

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    aspartate transaminase (ast)/alanine transaminase (alt) =< 2.5 x uln
    Description

    aspartate transaminase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0004002
    alkaline phosphatase =< 2.5 x uln
    Description

    alkaline phosphatase

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201850
    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
    Description

    Revlimid

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1135145
    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
    Description

    negative serum or urine pregnancy test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0430061
    UMLS CUI [2]
    C0430057
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patient must not undergo concomitant radiotherapy, chemotherapy or immunotherapy; patient must not be in concurrent study with other investigational agents
    Description

    Concomitant Therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1707479
    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
    Description

    lenalidomide therapy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1144149
    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
    Description

    concurrent disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    have significant, uncontrolled active infection
    Description

    active infection

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    pregnant or nursing patients will be excluded from the study
    Description

    pregnant or nursing patients

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0549206
    UMLS CUI [2]
    C0006147
    known human immunodeficiency virus (hiv) infection
    Description

    hiv

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0019682

    Similar models

    Eligibility Adult Acute Megakaryoblastic Leukemia (M7) NCT01904643

    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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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