ID

13254

Beskrivning

Safety & Efficacy Study of Oral Panobinostat (LBH589) With Chemotherapy in Patients < 65 Years Old With Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT01242774

Länk

https://clinicaltrials.gov/show/NCT01242774

Nyckelord

  1. 2016-01-26 2016-01-26 -
Rättsinnehavare

CC BY-NC 3.0

Uppladdad den

26 januari 2016

DOI

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Licens

Creative Commons BY-NC 3.0

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Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
Beskrivning

AML

Datatyp

boolean

Alias
UMLS CUI [1]
C0023467
= 20% bone marrow blasts via bone marrow aspiration or biopsy
Beskrivning

bone marrow blasts

Datatyp

boolean

Alias
UMLS CUI [1]
C0368761
the patient has not yet been treated for aml
Beskrivning

prior treatment for aml

Datatyp

boolean

Alias
UMLS CUI [1]
C0087111
1º or 2º aml patients with high-risk category features
Beskrivning

high-risk category

Datatyp

boolean

Alias
UMLS CUI [1]
C0086930
ecog ps = 2
Beskrivning

ECOG

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
renal function and liver function limits.
Beskrivning

renal and hepatic function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
Beskrivning

cytogenetic profile

Datatyp

boolean

Alias
UMLS CUI [1]
C0010802
patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
Beskrivning

cns leukemia

Datatyp

boolean

Alias
UMLS CUI [1]
C1332884
prior treatment with deacetylase inhibitors (daci) including, panobinostat
Beskrivning

deacetylase inhibitors

Datatyp

boolean

Alias
UMLS CUI [1]
C1333261
impaired cardiac function
Beskrivning

cardiac function

Datatyp

boolean

Alias
UMLS CUI [1]
C0232164
female patient who is pregnant or breast feeding
Beskrivning

pregnancy or lactation

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
male patient who is not willing to use a barrier method of contraception
Beskrivning

contraception

Datatyp

boolean

Alias
UMLS CUI [1]
C0700589

Similar models

Eligibility Acute Myeloid Leukemia (AML) NCT01242774

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
AML
Item
newly diagnosed adult patients = 65 years old with a cytopathologically confirmed diagnosis of high-risk aml
boolean
C0023467 (UMLS CUI [1])
bone marrow blasts
Item
= 20% bone marrow blasts via bone marrow aspiration or biopsy
boolean
C0368761 (UMLS CUI [1])
prior treatment for aml
Item
the patient has not yet been treated for aml
boolean
C0087111 (UMLS CUI [1])
high-risk category
Item
1º or 2º aml patients with high-risk category features
boolean
C0086930 (UMLS CUI [1])
ECOG
Item
ecog ps = 2
boolean
C1520224 (UMLS CUI [1])
renal and hepatic function
Item
renal function and liver function limits.
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
cytogenetic profile
Item
patient with a 'favorable' or 'better-risk' cytogenetic profile = t(15;17); t(8;21); or inv(16) or t(16;16)
boolean
C0010802 (UMLS CUI [1])
cns leukemia
Item
patient has clinical symptoms suggestive of cns leukemia and/or csf findings for cns leukemia
boolean
C1332884 (UMLS CUI [1])
deacetylase inhibitors
Item
prior treatment with deacetylase inhibitors (daci) including, panobinostat
boolean
C1333261 (UMLS CUI [1])
cardiac function
Item
impaired cardiac function
boolean
C0232164 (UMLS CUI [1])
pregnancy or lactation
Item
female patient who is pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
contraception
Item
male patient who is not willing to use a barrier method of contraception
boolean
C0700589 (UMLS CUI [1])

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