Information:
Fel:
ID
12574
Beskrivning
Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01804101
Länk
https://clinicaltrials.gov/show/NCT01804101
Nyckelord
Versioner (1)
- 2015-12-02 2015-12-02 -
Uppladdad den
2 december 2015
DOI
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Licens
Creative Commons BY 4.0
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Eligibility Acute Biphenotypic Leukemia NCT01804101
Eligibility Acute Biphenotypic Leukemia NCT01804101
- StudyEvent: Eligibility
Similar models
Eligibility Acute Biphenotypic Leukemia NCT01804101
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
untreated high-risk myelodysplastic syndrome or aml
Item
Diagnosis of untreated high-risk myelodysplastic syndrome (>= 10% blasts) or aml
boolean
C3463824 (UMLS CUI [1])
C0026998 (UMLS CUI [2])
C0026998 (UMLS CUI [2])
prior hydroxyurea for aml
Item
prior hydroxyurea for aml is permitted but should be discontinued prior to start of cpx-351 treatment
boolean
C0020402 (UMLS CUI [1])
C0521104 (UMLS CUI [2])
C1706472 (UMLS CUI [3])
C0521104 (UMLS CUI [2])
C1706472 (UMLS CUI [3])
discontinue treatment for myelodysplastic syndrome
Item
azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk mds (< 10% blasts); all treatments for mds should be discontinued prior to start of cpx-351 treatment
boolean
C0584668 (UMLS CUI [1])
treatment-related mortality score
Item
treatment-related mortality (trm) score >= 13.1 as calculated with simplified model
boolean
C0457450 (UMLS CUI [1])
Liver function
Item
bilirubin < 2.0 mg/ml x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
boolean
C0232741 (UMLS CUI [1])
Liver function
Item
aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 4.0 x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
boolean
C0232741 (UMLS CUI [1])
left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) >= 40%, assessed within 28 days prior to registration, e.g. by multi gated acquisition (muga) scan or echocardiography, or other appropriate diagnostic modality
boolean
C0428772 (UMLS CUI [1])
hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
Item
patients with symptoms/signs of hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
boolean
C3805210 (UMLS CUI [1])
C0023416 (UMLS CUI [2])
C0023416 (UMLS CUI [2])
informed consent
Item
provide signed written informed consent
boolean
C0021430 (UMLS CUI [1])
refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
Item
refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
boolean
C2861579 (UMLS CUI [1])
C0205269 (UMLS CUI [2])
C0205269 (UMLS CUI [2])
Comorbidity with a likely survival of < 1 year
Item
concomitant illness associated with a likely survival of < 1 year
boolean
C0009488 (UMLS CUI [1])
C2919552 (UMLS CUI [2])
C2919552 (UMLS CUI [2])
infection, unless under treatment
Item
active systemic fungal, bacterial, viral, or other infection, unless under treatment with anti-microbials and controlled/stable, as defined as being afebrile and hemodynamically stable for 24-48 hours
boolean
C0009450 (UMLS CUI [1])
C0087111 (UMLS CUI [2])
C0087111 (UMLS CUI [2])