ID

12574

Beschrijving

Liposomal Cytarabine-Daunorubicin CPX-351 in Treating Patients With Untreated Myelodysplastic Syndrome or Acute Myeloid Leukemia; ODM derived from: https://clinicaltrials.gov/show/NCT01804101

Link

https://clinicaltrials.gov/show/NCT01804101

Trefwoorden

Versies (1)
  1. 02-12-15 02-12-15 -
Geüploaded op

2 december 2015

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Acute Biphenotypic Leukemia NCT01804101

Engels

Eligibility Acute Biphenotypic Leukemia NCT01804101

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
Diagnosis of untreated high-risk myelodysplastic syndrome (>= 10% blasts) or aml
Beschrijving

other than acute promyelocytic leukemia (apl) with t(15;17)(q22;q12) or variants according to the 2008 world health organization (who) classification; patients with biphenotypic aml are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available

Datatype

boolean

Alias
UMLS CUI [1]
C3463824
UMLS CUI [2]
C0026998
prior hydroxyurea for aml is permitted but should be discontinued prior to start of cpx-351 treatment
Beschrijving

prior hydroxyurea for aml

Datatype

boolean

Alias
UMLS CUI [1]
C0020402
UMLS CUI [2]
C0521104
UMLS CUI [3]
C1706472
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
Beschrijving

discontinue treatment for myelodysplastic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C0584668
treatment-related mortality (trm) score >= 13.1 as calculated with simplified model
Beschrijving

treatment-related mortality score

Datatype

boolean

Alias
UMLS CUI [1]
C0457450
bilirubin < 2.0 mg/ml x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
aspartate aminotransferase (ast)/alanine aminotransferase (alt) < 4.0 x upper limit of normal; this requirement reflects the excretion of cpx-351 by the liver
Beschrijving

Liver function

Datatype

boolean

Alias
UMLS CUI [1]
C0232741
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
Beschrijving

left ventricular ejection fraction

Datatype

boolean

Alias
UMLS CUI [1]
C0428772
patients with symptoms/signs of hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment
Beschrijving

hyperleukocytosis or white blood cell count (wbc) > 100,000/ul can be treated with leukapheresis prior to enrollment

Datatype

boolean

Alias
UMLS CUI [1]
C3805210
UMLS CUI [2]
C0023416
provide signed written informed consent
Beschrijving

informed consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)
Beschrijving

refractory/relapsing blast crisis of chronic myelogenous leukemia (cml)

Datatype

boolean

Alias
UMLS CUI [1]
C2861579
UMLS CUI [2]
C0205269
concomitant illness associated with a likely survival of < 1 year
Beschrijving

Comorbidity with a likely survival of < 1 year

Datatype

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C2919552
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
Beschrijving

infection, unless under treatment

Datatype

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0087111
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Similar models

Eligibility Acute Biphenotypic Leukemia NCT01804101

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
informed consent
Item
provide signed written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])
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