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ID

21406

Beskrivning

Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes; ODM derived from: https://clinicaltrials.gov/show/NCT00454480

Länk

https://clinicaltrials.gov/show/NCT00454480

Nyckelord

Versioner (1)
  1. 2017-04-19 2017-04-19 -
Uppladdad den

19 april 2017

DOI

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Creative Commons BY 4.0
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    Eligibility Leukemia NCT00454480

    Engelsk

    Eligibility Leukemia NCT00454480

    1 Formulär  
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00454480
    Criteria
    Beskrivning

    Criteria

    diagnosis of 1 of the following:
    Beskrivning

    Diagnosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0011900
    acute myeloid leukemia (aml) meeting the following criteria:
    Beskrivning

    Leukemia, Myelocytic, Acute

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    de novo or secondary aml
    Beskrivning

    Acute Myelocytic Leukemia de novo | secondary acute myeloid leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C1515568
    UMLS CUI [2]
    C0280449
    no acute promyelocytic leukemia
    Beskrivning

    Acute Promyelocytic Leukemia Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023487
    UMLS CUI [1,2]
    C0332197
    high-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
    Beskrivning

    MYELODYSPLASTIC SYNDROME High risk | Bone marrow Blasts Percentage | Refractory anemia with excess blasts II

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C3463824
    UMLS CUI [1,2]
    C0332167
    UMLS CUI [2,1]
    C1982687
    UMLS CUI [2,2]
    C0439165
    UMLS CUI [3]
    C1318551
    no blast transformation of chronic myeloid leukemia
    Beskrivning

    Chronic Myeloid Leukemia Blast transformation Absent

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0023473
    UMLS CUI [1,2]
    C0024262
    UMLS CUI [1,3]
    C0332197
    patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial mrc-amli5
    Beskrivning

    Age | Unfit Clinical Trial specified

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    UMLS CUI [2,1]
    C3841806
    UMLS CUI [2,2]
    C0008976
    UMLS CUI [2,3]
    C0205369
    patient characteristics:
    Beskrivning

    Client Characteristics

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0815172
    not pregnant or nursing
    Beskrivning

    Pregnancy | Breast Feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    ast and alt ≤ 2 times upper limit of normal (uln) (for patients receiving gemtuzumab ozogamicin)
    Beskrivning

    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gemtuzumab ozogamicin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201899
    UMLS CUI [2]
    C0201836
    UMLS CUI [3]
    C1533699
    bilirubin ≤ 2 times uln (for patients receiving gemtuzumab ozogamicin)
    Beskrivning

    Serum total bilirubin measurement | Gemtuzumab ozogamicin

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C1533699
    creatinine normal (for patients receiving clofarabine)
    Beskrivning

    Serum creatinine normal | clofarabine

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0438244
    UMLS CUI [2]
    C0092777
    no other concurrent active malignancy except basal cell carcinoma
    Beskrivning

    Malignant Neoplasm | Basal cell carcinoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2]
    C0007117
    prior concurrent therapy:
    Beskrivning

    Therapeutic procedure

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0087111
    no prior cytotoxic chemotherapy for aml
    Beskrivning

    Cytotoxic Chemotherapy Acute Myelocytic Leukemia

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0677881
    UMLS CUI [1,2]
    C0023467
    hydroxyurea or similar low-dose therapy to control wbc count prior to initiation of intensive therapy allowed
    Beskrivning

    hydroxyurea | Low-Dose Treatment Similar | White Blood Cell Count | Initiation Therapeutic procedure Intensity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020402
    UMLS CUI [2,1]
    C1708745
    UMLS CUI [2,2]
    C2348205
    UMLS CUI [3]
    C0023508
    UMLS CUI [4,1]
    C1704686
    UMLS CUI [4,2]
    C0087111
    UMLS CUI [4,3]
    C0522510
    no concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
    Beskrivning

    Anticonvulsants Enzyme Induction | Phenytoin | Phenobarbital | Primidone | Carbamazepine | oxcarbazepine | tipifarnib

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0003286
    UMLS CUI [1,2]
    C0014431
    UMLS CUI [2]
    C0031507
    UMLS CUI [3]
    C0031412
    UMLS CUI [4]
    C0033148
    UMLS CUI [5]
    C0006949
    UMLS CUI [6]
    C0069751
    UMLS CUI [7]
    C1176289
    Tillbaka till toppen

    Similar models

    Eligibility Leukemia NCT00454480

    1 Formulär
    1. StudyEvent: Eligibility
      1. Eligibility Leukemia NCT00454480
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Diagnosis
    Item
    diagnosis of 1 of the following:
    boolean
    C0011900 (UMLS CUI [1])
    Leukemia, Myelocytic, Acute
    Item
    acute myeloid leukemia (aml) meeting the following criteria:
    boolean
    C0023467 (UMLS CUI [1])
    Acute Myelocytic Leukemia de novo | secondary acute myeloid leukemia
    Item
    de novo or secondary aml
    boolean
    C0023467 (UMLS CUI [1,1])
    C1515568 (UMLS CUI [1,2])
    C0280449 (UMLS CUI [2])
    Acute Promyelocytic Leukemia Absent
    Item
    no acute promyelocytic leukemia
    boolean
    C0023487 (UMLS CUI [1,1])
    C0332197 (UMLS CUI [1,2])
    MYELODYSPLASTIC SYNDROME High risk | Bone marrow Blasts Percentage | Refractory anemia with excess blasts II
    Item
    high-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
    boolean
    C3463824 (UMLS CUI [1,1])
    C0332167 (UMLS CUI [1,2])
    C1982687 (UMLS CUI [2,1])
    C0439165 (UMLS CUI [2,2])
    C1318551 (UMLS CUI [3])
    Chronic Myeloid Leukemia Blast transformation Absent
    Item
    no blast transformation of chronic myeloid leukemia
    boolean
    C0023473 (UMLS CUI [1,1])
    C0024262 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    Age | Unfit Clinical Trial specified
    Item
    patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial mrc-amli5
    boolean
    C0001779 (UMLS CUI [1])
    C3841806 (UMLS CUI [2,1])
    C0008976 (UMLS CUI [2,2])
    C0205369 (UMLS CUI [2,3])
    Client Characteristics
    Item
    patient characteristics:
    boolean
    C0815172 (UMLS CUI [1])
    Pregnancy | Breast Feeding
    Item
    not pregnant or nursing
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Gemtuzumab ozogamicin
    Item
    ast and alt ≤ 2 times upper limit of normal (uln) (for patients receiving gemtuzumab ozogamicin)
    boolean
    C0201899 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    C1533699 (UMLS CUI [3])
    Serum total bilirubin measurement | Gemtuzumab ozogamicin
    Item
    bilirubin ≤ 2 times uln (for patients receiving gemtuzumab ozogamicin)
    boolean
    C1278039 (UMLS CUI [1])
    C1533699 (UMLS CUI [2])
    Serum creatinine normal | clofarabine
    Item
    creatinine normal (for patients receiving clofarabine)
    boolean
    C0438244 (UMLS CUI [1])
    C0092777 (UMLS CUI [2])
    Malignant Neoplasm | Basal cell carcinoma
    Item
    no other concurrent active malignancy except basal cell carcinoma
    boolean
    C0006826 (UMLS CUI [1])
    C0007117 (UMLS CUI [2])
    Therapeutic procedure
    Item
    prior concurrent therapy:
    boolean
    C0087111 (UMLS CUI [1])
    Cytotoxic Chemotherapy Acute Myelocytic Leukemia
    Item
    no prior cytotoxic chemotherapy for aml
    boolean
    C0677881 (UMLS CUI [1,1])
    C0023467 (UMLS CUI [1,2])
    hydroxyurea | Low-Dose Treatment Similar | White Blood Cell Count | Initiation Therapeutic procedure Intensity
    Item
    hydroxyurea or similar low-dose therapy to control wbc count prior to initiation of intensive therapy allowed
    boolean
    C0020402 (UMLS CUI [1])
    C1708745 (UMLS CUI [2,1])
    C2348205 (UMLS CUI [2,2])
    C0023508 (UMLS CUI [3])
    C1704686 (UMLS CUI [4,1])
    C0087111 (UMLS CUI [4,2])
    C0522510 (UMLS CUI [4,3])
    Anticonvulsants Enzyme Induction | Phenytoin | Phenobarbital | Primidone | Carbamazepine | oxcarbazepine | tipifarnib
    Item
    no concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
    boolean
    C0003286 (UMLS CUI [1,1])
    C0014431 (UMLS CUI [1,2])
    C0031507 (UMLS CUI [2])
    C0031412 (UMLS CUI [3])
    C0033148 (UMLS CUI [4])
    C0006949 (UMLS CUI [5])
    C0069751 (UMLS CUI [6])
    C1176289 (UMLS CUI [7])
    Tillbaka till toppen 

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