ID

77

Beskrivning

Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) Inclusion criteria: - cytological confirmation of AML - relapsed disease following first CR of 1 month(30days) to 24 months(730days). The time from first relapse to study entry (start of first course of induction chemotherapy) must be no longer than 30days - confirmation of FLT-3 activating mutation positive status after point of initial relapse - aged 18 years or older - written informed consent - ability to understand and comply with study restrictions - no comorbid conditions that would limit life expectancy to less than 3 months - ECOG Performance Score of 0, 1,or 2 - women must be neither pregnant nor lactating, and either of non-childbearing potential or using adequate contraception with a negative pregnancy test at study entry Exclusion criteria - bilirubin more than 2x ULN - ALT/AST more than 3x ULN - serum creatinine more than 1.5 mg/dL - resting ejection fraction of left ventricle l less than 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC) - untreated or progressive infection - any physical or psychiatric cdtn that may compromise participation in the study - known CNS involvement with AML - any previous treatment with a FLT-3 inhibitor - requires current treatment for HIV with protease inhibitors - active GI ulceration or bleeding - use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment

Nyckelord

Versioner (3)
  1. 2011-11-18 2011-11-18 -
  2. 2014-03-26 2014-03-26 - Martin Dugas
  3. 2021-09-17 2021-09-17 -
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18 november 2011

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Eligibility NCT00079482 AML

Tysk Engelsk

Eligibility

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Beskrivning

Einschlusskriterien

AML
Beskrivning

AML

Datatyp

boolean

Relapse
Beskrivning

Relapse

Datatyp

boolean

FLT-3 mutation
Beskrivning

FLT-3 mutation

Datatyp

boolean

Age
Beskrivning

Age

Datatyp

boolean

Life expectancy
Beskrivning

Life expectancy

Datatyp

boolean

ECOG
Beskrivning

ECOG

Datatyp

boolean

Pregnancy / Lactation
Beskrivning

Pregnancy / Lactation

Datatyp

boolean

Ausschlusskriterien
Beskrivning

Ausschlusskriterien

Bilirubin
Beskrivning

Bilirubin

Datatyp

boolean

ALT / AST
Beskrivning

ALT / AST

Datatyp

boolean

Serum creatinine
Beskrivning

Serum creatinine

Datatyp

boolean

Ejection fraction
Beskrivning

Ejection fraction

Datatyp

boolean

Infection
Beskrivning

Infection

Datatyp

boolean

Major physical or psychiatric condition
Beskrivning

Major physical or psychiatric condition

Datatyp

boolean

CNS involvement
Beskrivning

CNS involvement

Datatyp

boolean

Previous FLT-3 inhibitor
Beskrivning

Previous FLT-3 inhibitor

Datatyp

boolean

HIV treatment
Beskrivning

HIV treatment

Datatyp

boolean

Gastrointestinal ulceration or bleeding
Beskrivning

Gastrointestinal ulceration or bleeding

Datatyp

boolean

Other investigational drug
Beskrivning

Other investigational drug

Datatyp

boolean

Medizinische Konzepte
Beskrivning

Medizinische Konzepte

Diagnosis
Beskrivning

Diagnosis

Datatyp

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
AML
Beskrivning

AML

Datatyp

string

Alias
UMLS CUI
C0023467
SNOMED CT 2010_0731
91861009
MedDRA 13.1
10000884
Relapse
Beskrivning

Relapse

Datatyp

string

Alias
UMLS CUI
C0035020
SNOMED CT 2010_0731
263855007
MedDRA 13.1
10000884
FLT3 gene mutation analysis
Beskrivning

FLT3 gene mutation analysis

Datatyp

string

Alias
UMLS CUI
C1953284
Age
Beskrivning

Age

Datatyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Compliance
Beskrivning

Compliance

Datatyp

string

Alias
UMLS CUI
C1321605
SNOMED CT 2010_0731
405078008
Life expectancy
Beskrivning

Life expectancy

Datatyp

string

Alias
UMLS CUI
C0023671
LOINC Version 232
LP75025-4
ECOG performance status
Beskrivning

ECOG performance status

Datatyp

string

Alias
SNOMED CT 2010_0731
423740007
pregnant
Beskrivning

pregnant

Datatyp

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Lactation
Beskrivning

Lactation

Datatyp

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Bilirubin
Beskrivning

Bilirubin

Datatyp

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
MedDRA Version 13.1
10004683
LOINC
1975-2
AST
Beskrivning

AST

Datatyp

string

Alias
SNOMED CT 2010_0731
26091008
UMLS CUI
C0004002
MedDRA Version 13.1
10003543
LOINC
1920-8
ALT
Beskrivning

ALT

Datatyp

string

Alias
SNOMED CT 2010_0731
56935002
UMLS CUI
C0001899
MedDRA Version 13.1
10001844
LOINC
1742-6
Creatinine
Beskrivning

Creatinine

Datatyp

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Cardiac ejection fraction
Beskrivning

Cardiac ejection fraction

Datatyp

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
Infection
Beskrivning

Infection

Datatyp

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA Version 13.1
10021789
CNS involvement
Beskrivning

CNS involvement

Datatyp

string

Alias
UMLS CUI
C0449389
SNOMED CT 2010_0731
260766009
Pharmaceutical Preparations
Beskrivning

Pharmaceutical Preparations

Datatyp

string

Alias
UMLS CUI
C0013227
HIV negative
Beskrivning

HIV negative

Datatyp

string

Alias
UMLS CUI
C0481430
SNOMED CT 2010_0731
143223008
Gastrointestinal ulcer
Beskrivning

Gastrointestinal ulcer

Datatyp

string

Alias
UMLS CUI
C0237938
SNOMED CT 2010_0731
40845000
MedDRA Version 13.1
10061459
Gastrointestinal hemorrhage
Beskrivning

Gastrointestinal hemorrhage

Datatyp

string

Alias
UMLS CUI
C0017181
SNOMED CT 2010_0731
74474003
MedDRA Version 13.1
10017936
Enrollment
Beskrivning

Enrollment

Datatyp

string

Alias
UMLS CUI
C1516879
Tillbaka till toppen

Similar models

Eligibility

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Einschlusskriterien
AML
Item
boolean
Relapse
Item
boolean
FLT-3 mutation
Item
boolean
Age
Item
boolean
Life expectancy
Item
boolean
ECOG
Item
boolean
Pregnancy / Lactation
Item
boolean
Item Group
Ausschlusskriterien
Bilirubin
Item
boolean
ALT / AST
Item
boolean
Serum creatinine
Item
boolean
Ejection fraction
Item
boolean
Infection
Item
boolean
Major physical or psychiatric condition
Item
boolean
CNS involvement
Item
boolean
Previous FLT-3 inhibitor
Item
boolean
HIV treatment
Item
boolean
Gastrointestinal ulceration or bleeding
Item
boolean
Other investigational drug
Item
boolean
Item Group
Medizinische Konzepte
Diagnosis
Item
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
AML
Item
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
Relapse
Item
string
C0035020 (UMLS CUI)
263855007 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
FLT3 gene mutation analysis
Item
string
C1953284 (UMLS CUI)
Age
Item
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Compliance
Item
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Life expectancy
Item
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
ECOG performance status
Item
string
423740007 (SNOMED CT 2010_0731)
pregnant
Item
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Bilirubin
Item
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
10004683 (MedDRA Version 13.1)
1975-2 (LOINC)
AST
Item
string
26091008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
10003543 (MedDRA Version 13.1)
1920-8 (LOINC)
ALT
Item
string
56935002 (SNOMED CT 2010_0731)
C0001899 (UMLS CUI)
10001844 (MedDRA Version 13.1)
1742-6 (LOINC)
Creatinine
Item
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Cardiac ejection fraction
Item
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Infection
Item
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
CNS involvement
Item
string
C0449389 (UMLS CUI)
260766009 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
string
C0013227 (UMLS CUI)
HIV negative
Item
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
Gastrointestinal ulcer
Item
string
C0237938 (UMLS CUI)
40845000 (SNOMED CT 2010_0731)
10061459 (MedDRA Version 13.1)
Gastrointestinal hemorrhage
Item
string
C0017181 (UMLS CUI)
74474003 (SNOMED CT 2010_0731)
10017936 (MedDRA Version 13.1)
Enrollment
Item
string
C1516879 (UMLS CUI)
Tillbaka till toppen 

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