ID

77

Description

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

Keywords

Versions (3)
  1. 11/18/11 11/18/11 -
  2. 3/26/14 3/26/14 - Martin Dugas
  3. 9/17/21 9/17/21 -
Uploaded on

November 18, 2011

DOI

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License

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00079482 AML

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

cytological confirmation of AML
Description

AML

Data type

boolean

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
Description

Relapse

Data type

boolean

confirmation of FLT-3 activating mutation positive status after point of initial relapse
Description

FLT-3 mutation

Data type

boolean

aged 18 years or older
Description

Age

Data type

boolean

no comorbid conditions that would limit life expectancy to less than 3 months
Description

Life expectancy

Data type

boolean

ECOG Performance Score of 0, 1,or 2
Description

ECOG

Data type

boolean

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
Description

Pregnancy / Lactation

Data type

boolean

Exclusion criteria
Description

Exclusion criteria

bilirubin > 2x ULN
Description

Bilirubin

Data type

boolean

ALT/AST > 3x ULN
Description

ALT / AST

Data type

boolean

serum creatinine > 1.5 mg/dL
Description

Serum creatinine

Data type

boolean

resting ejection fraction of left ventricle l < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC)
Description

Ejection fraction

Data type

boolean

untreated or progressive infection
Description

Infection

Data type

boolean

any physical or psychiatric condition that may compromise participation in the study
Description

Major physical or psychiatric condition

Data type

boolean

known CNS involvement with AML
Description

CNS involvement

Data type

boolean

any previous treatment with a FLT-3 inhibitor
Description

Previous FLT-3 inhibitor

Data type

boolean

requires current treatment for HIV with protease inhibitors
Description

HIV treatment

Data type

boolean

active GI ulceration or bleeding
Description

Gastrointestinal ulceration or bleeding

Data type

boolean

use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
Description

Other investigational drug

Data type

boolean

Medical Concepts
Description

Medical Concepts

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
Acute myeloid leukemia
Description

AML

Data type

string

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

Relapse

Data type

string

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

FLT3 gene mutation analysis

Data type

string

Alias
UMLS CUI
C1953284
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Compliance behavior
Description

Compliance

Data type

string

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

Life expectancy

Data type

string

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

ECOG performance status

Data type

string

Alias
SNOMED CT 2010_0731
423740007
pregnant
Description

pregnant

Data type

string

Alias
UMLS CUI
C0549206
MedDRA 13.1
10036586
Breast feeding
Description

Lactation

Data type

string

Alias
UMLS CUI
C0006147
MedDRA 13.1
10006247
Bilirubin
Description

Bilirubin

Data type

string

Alias
SNOMED CT 2010_0731
79706000
UMLS CUI
C0011221
MedDRA Version 13.1
10004683
LOINC
1975-2
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
Description

AST

Data type

string

Alias
SNOMED CT 2010_0731
26091008
UMLS CUI
C0004002
MedDRA Version 13.1
10003543
LOINC
1920-8
Alanine Transaminase (ALT) = glutamate pyruvate transaminase (GPT)
Description

ALT

Data type

string

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

Creatinine

Data type

string

Alias
UMLS CUI
C0010294
SNOMED CT 2010_0731
15373003
LOINC
38483-4
MedDRA 13.1
10011358
Ejection fraction
Description

Cardiac ejection fraction

Data type

string

Alias
UMLS CUI
C0232174
SNOMED CT 2010_0731
70822001
Infection
Description

Infection

Data type

string

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

CNS involvement

Data type

string

Alias
UMLS CUI
C0449389
SNOMED CT 2010_0731
260766009
Medication
Description

Pharmaceutical Preparations

Data type

string

Alias
UMLS CUI
C0013227
HIV negative
Description

HIV negative

Data type

string

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

Gastrointestinal ulcer

Data type

string

Alias
UMLS CUI
C0237938
SNOMED CT 2010_0731
40845000
MedDRA Version 13.1
10061459
Gastrointestinal bleeding
Description

Gastrointestinal hemorrhage

Data type

string

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

Enrollment

Data type

string

Alias
UMLS CUI
C1516879
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Similar models

Eligibility

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
AML
Item
cytological confirmation of AML
boolean
Relapse
Item
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
boolean
FLT-3 mutation
Item
confirmation of FLT-3 activating mutation positive status after point of initial relapse
boolean
Age
Item
aged 18 years or older
boolean
Life expectancy
Item
no comorbid conditions that would limit life expectancy to less than 3 months
boolean
ECOG
Item
ECOG Performance Score of 0, 1,or 2
boolean
Pregnancy / Lactation
Item
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
boolean
Item Group
Exclusion criteria
Bilirubin
Item
bilirubin > 2x ULN
boolean
ALT / AST
Item
ALT/AST > 3x ULN
boolean
Serum creatinine
Item
serum creatinine > 1.5 mg/dL
boolean
Ejection fraction
Item
resting ejection fraction of left ventricle l < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC)
boolean
Infection
Item
untreated or progressive infection
boolean
Major physical or psychiatric condition
Item
any physical or psychiatric condition that may compromise participation in the study
boolean
CNS involvement
Item
known CNS involvement with AML
boolean
Previous FLT-3 inhibitor
Item
any previous treatment with a FLT-3 inhibitor
boolean
HIV treatment
Item
requires current treatment for HIV with protease inhibitors
boolean
Gastrointestinal ulceration or bleeding
Item
active GI ulceration or bleeding
boolean
Other investigational drug
Item
use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
boolean
Item Group
Medical Concepts
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
439401001 (SNOMED CT 2010_0731)
AML
Item
Acute myeloid leukemia
string
C0023467 (UMLS CUI)
91861009 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
Relapse
Item
Relapse phase
string
C0035020 (UMLS CUI)
263855007 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
FLT3 gene mutation analysis
Item
FLT3 gene mutation analysis
string
C1953284 (UMLS CUI)
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Compliance
Item
Compliance behavior
string
C1321605 (UMLS CUI)
405078008 (SNOMED CT 2010_0731)
Life expectancy
Item
Life expectancy
string
C0023671 (UMLS CUI)
LP75025-4 (LOINC Version 232)
ECOG performance status
Item
ECOG performance status
string
423740007 (SNOMED CT 2010_0731)
pregnant
Item
pregnant
string
C0549206 (UMLS CUI)
10036586 (MedDRA 13.1)
Lactation
Item
Breast feeding
string
C0006147 (UMLS CUI)
10006247 (MedDRA 13.1)
Bilirubin
Item
Bilirubin
string
79706000 (SNOMED CT 2010_0731)
C0011221 (UMLS CUI)
10004683 (MedDRA Version 13.1)
1975-2 (LOINC)
AST
Item
Glutamate oxaloacetate transaminase (GOT) = Aspartate Transaminase (AST)
string
26091008 (SNOMED CT 2010_0731)
C0004002 (UMLS CUI)
10003543 (MedDRA Version 13.1)
1920-8 (LOINC)
ALT
Item
Alanine Transaminase (ALT) = glutamate pyruvate transaminase (GPT)
string
56935002 (SNOMED CT 2010_0731)
C0001899 (UMLS CUI)
10001844 (MedDRA Version 13.1)
1742-6 (LOINC)
Creatinine
Item
Creatinine
string
C0010294 (UMLS CUI)
15373003 (SNOMED CT 2010_0731)
38483-4 (LOINC)
10011358 (MedDRA 13.1)
Cardiac ejection fraction
Item
Ejection fraction
string
C0232174 (UMLS CUI)
70822001 (SNOMED CT 2010_0731)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
CNS involvement
Item
CNS involvement status
string
C0449389 (UMLS CUI)
260766009 (SNOMED CT 2010_0731)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
HIV negative
Item
HIV negative
string
C0481430 (UMLS CUI)
143223008 (SNOMED CT 2010_0731)
Gastrointestinal ulcer
Item
Gastrointestinal ulcer
string
C0237938 (UMLS CUI)
40845000 (SNOMED CT 2010_0731)
10061459 (MedDRA Version 13.1)
Gastrointestinal hemorrhage
Item
Gastrointestinal bleeding
string
C0017181 (UMLS CUI)
74474003 (SNOMED CT 2010_0731)
10017936 (MedDRA Version 13.1)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
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