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

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Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00079482 AML

German English

Eligibility

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility
Einschlusskriterien
Description

Einschlusskriterien

AML
Description

AML

Data type

boolean

Relapse
Description

Relapse

Data type

boolean

FLT-3 mutation
Description

FLT-3 mutation

Data type

boolean

Age
Description

Age

Data type

boolean

Life expectancy
Description

Life expectancy

Data type

boolean

ECOG
Description

ECOG

Data type

boolean

Pregnancy / Lactation
Description

Pregnancy / Lactation

Data type

boolean

Ausschlusskriterien
Description

Ausschlusskriterien

Bilirubin
Description

Bilirubin

Data type

boolean

ALT / AST
Description

ALT / AST

Data type

boolean

Serum creatinine
Description

Serum creatinine

Data type

boolean

Ejection fraction
Description

Ejection fraction

Data type

boolean

Infection
Description

Infection

Data type

boolean

Major physical or psychiatric condition
Description

Major physical or psychiatric condition

Data type

boolean

CNS involvement
Description

CNS involvement

Data type

boolean

Previous FLT-3 inhibitor
Description

Previous FLT-3 inhibitor

Data type

boolean

HIV treatment
Description

HIV treatment

Data type

boolean

Gastrointestinal ulceration or bleeding
Description

Gastrointestinal ulceration or bleeding

Data type

boolean

Other investigational drug
Description

Other investigational drug

Data type

boolean

Medizinische Konzepte
Description

Medizinische Konzepte

Diagnosis
Description

Diagnosis

Data type

string

Alias
UMLS CUI
C0011900
SNOMED CT 2010_0731
439401001
AML
Description

AML

Data type

string

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

AST

Data type

string

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

CNS involvement

Data type

string

Alias
UMLS CUI
C0449389
SNOMED CT 2010_0731
260766009
Pharmaceutical Preparations
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 hemorrhage
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
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)
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