ID

31748

Beschrijving

Efficacy and Safety of Panobinostat (LBH5789) in Patients With Refractory de Novo or Secondary Acute Myelogenous Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00880269

Link

https://clinicaltrials.gov/show/NCT00880269

Trefwoorden

Versies (1)
  1. 25-09-18 25-09-18 -
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See clinicaltrials.gov

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25 september 2018

DOI

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Creative Commons BY 4.0
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Eligibility Refractory Leukemia NCT00880269

Engels

Eligibility Refractory Leukemia NCT00880269

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent prior to study-specific screening procedures
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
life expectancy of ≥ 60 days
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
eastern cooperative group (ecog) performance status ≤ 2
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
refractory aml with confirmed initial diagnosis of de novo aml (excluding apl) - or-
Beschrijving

Refractory AML | Diagnosis Initial AML de novo | APL Excluded

Datatype

boolean

Alias
UMLS CUI [1]
C4528668
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C0023467
UMLS CUI [2,4]
C1515568
UMLS CUI [3,1]
C0023487
UMLS CUI [3,2]
C0332196
refractory aml with confirmed initial diagnosis of aml (excluding apl) secondary to ahd or mds with either condition precedent to aml (mds/ahd)
Beschrijving

Refractory AML | Diagnosis Initial AML | APL Excluded | Secondary to Hematological Disease Antecedent | Secondary to Myelodysplastic syndrome

Datatype

boolean

Alias
UMLS CUI [1]
C4528668
UMLS CUI [2,1]
C0011900
UMLS CUI [2,2]
C0205265
UMLS CUI [2,3]
C0023467
UMLS CUI [3,1]
C0023487
UMLS CUI [3,2]
C0332196
UMLS CUI [4,1]
C0175668
UMLS CUI [4,2]
C0018939
UMLS CUI [4,3]
C0683336
UMLS CUI [5,1]
C0175668
UMLS CUI [5,2]
C3463824
negative serum pregnancy test (within 7 days of first dose)
Beschrijving

Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0430061
negative urine pregnancy test immediately prior to first dose
Beschrijving

Urine pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0430057
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
known hiv
Beschrijving

HIV Infection

Datatype

boolean

Alias
UMLS CUI [1]
C0019693
psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
Beschrijving

Mental disorder Interferes with Comprehension Study Protocol | Mental disorder Interferes with Informed Consent | Mental disorder Impact Study Subject Participation Status | Mental disorder Impact Follow-up

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0162340
UMLS CUI [1,4]
C2348563
UMLS CUI [2,1]
C0004936
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0021430
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C4049986
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C4049986
UMLS CUI [4,3]
C3274571
concurrent use of medications that might prolong the qt interval or of inducing torsade de pointes
Beschrijving

Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Inducing Torsades de Pointes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0151878
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0205263
UMLS CUI [2,3]
C0040479
female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
Beschrijving

Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception Double Unwilling

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0004764
UMLS CUI [3,3]
C0205173
UMLS CUI [3,4]
C0558080
male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
Beschrijving

Gender Partner Childbearing Potential | Contraceptive method Double Unwilling | Condoms, Male

Datatype

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0682323
UMLS CUI [1,3]
C3831118
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0205173
UMLS CUI [2,3]
C0558080
UMLS CUI [3]
C0009653
patient is unable to swallow capsules
Beschrijving

Lacking Able to swallow Capsules

Datatype

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0006935
patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
Beschrijving

Gastrointestinal system Impaired | Interference Digesting Panobinostat | Interference Absorption Panobinostat

Datatype

boolean

Alias
UMLS CUI [1,1]
C0012240
UMLS CUI [1,2]
C0221099
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
C0868946
UMLS CUI [2,3]
C1998098
UMLS CUI [3,1]
C0521102
UMLS CUI [3,2]
C0237442
UMLS CUI [3,3]
C1998098
other protocol-defined inclusion/exclusion criteria may apply
Beschrijving

Eligibility Criteria Study Protocol

Datatype

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
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Similar models

Eligibility Refractory Leukemia NCT00880269

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
written informed consent prior to study-specific screening procedures
boolean
C0021430 (UMLS CUI [1])
Life Expectancy
Item
life expectancy of ≥ 60 days
boolean
C0023671 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Refractory AML | Diagnosis Initial AML de novo | APL Excluded
Item
refractory aml with confirmed initial diagnosis of de novo aml (excluding apl) - or-
boolean
C4528668 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
C1515568 (UMLS CUI [2,4])
C0023487 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
Refractory AML | Diagnosis Initial AML | APL Excluded | Secondary to Hematological Disease Antecedent | Secondary to Myelodysplastic syndrome
Item
refractory aml with confirmed initial diagnosis of aml (excluding apl) secondary to ahd or mds with either condition precedent to aml (mds/ahd)
boolean
C4528668 (UMLS CUI [1])
C0011900 (UMLS CUI [2,1])
C0205265 (UMLS CUI [2,2])
C0023467 (UMLS CUI [2,3])
C0023487 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0175668 (UMLS CUI [4,1])
C0018939 (UMLS CUI [4,2])
C0683336 (UMLS CUI [4,3])
C0175668 (UMLS CUI [5,1])
C3463824 (UMLS CUI [5,2])
Serum pregnancy test negative
Item
negative serum pregnancy test (within 7 days of first dose)
boolean
C0430061 (UMLS CUI [1])
Urine pregnancy test negative
Item
negative urine pregnancy test immediately prior to first dose
boolean
C0430057 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
HIV Infection
Item
known hiv
boolean
C0019693 (UMLS CUI [1])
Mental disorder Interferes with Comprehension Study Protocol | Mental disorder Interferes with Informed Consent | Mental disorder Impact Study Subject Participation Status | Mental disorder Impact Follow-up
Item
psychiatric disorder that interferes with ability to understand the study and give informed consent, and/or would impact study participation or follow-up
boolean
C0004936 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0162340 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
C0004936 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0021430 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C4049986 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C4049986 (UMLS CUI [4,2])
C3274571 (UMLS CUI [4,3])
Pharmaceutical Preparations Causing Prolonged QT interval | Pharmaceutical Preparations Inducing Torsades de Pointes
Item
concurrent use of medications that might prolong the qt interval or of inducing torsade de pointes
boolean
C0013227 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0151878 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C0205263 (UMLS CUI [2,2])
C0040479 (UMLS CUI [2,3])
Pregnancy | Breast Feeding | Childbearing Potential Barrier Contraception Double Unwilling
Item
female patients who are pregnant or breast-feeding or patients of childbearing potential who are not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of study drug.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0004764 (UMLS CUI [3,2])
C0205173 (UMLS CUI [3,3])
C0558080 (UMLS CUI [3,4])
Gender Partner Childbearing Potential | Contraceptive method Double Unwilling | Condoms, Male
Item
male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double method of contraception, one of which includes a condom, during the study and for 3 months after the end of treatment
boolean
C0079399 (UMLS CUI [1,1])
C0682323 (UMLS CUI [1,2])
C3831118 (UMLS CUI [1,3])
C0700589 (UMLS CUI [2,1])
C0205173 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C0009653 (UMLS CUI [3])
Lacking Able to swallow Capsules
Item
patient is unable to swallow capsules
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0006935 (UMLS CUI [1,3])
Gastrointestinal system Impaired | Interference Digesting Panobinostat | Interference Absorption Panobinostat
Item
patients with impaired gastrointestinal systems which might cause interference with digesting and absorbing panobinostat
boolean
C0012240 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0521102 (UMLS CUI [2,1])
C0868946 (UMLS CUI [2,2])
C1998098 (UMLS CUI [2,3])
C0521102 (UMLS CUI [3,1])
C0237442 (UMLS CUI [3,2])
C1998098 (UMLS CUI [3,3])
Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
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