ID

42987

Description

Study of CEP-701 in Patients With Acute Myeloid Leukemia (AML) See http://clinicaltrials.gov/ct2/show/study/NCT00079482

Link

http://clinicaltrials.gov/ct2/show/study/NCT00079482

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

September 17, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility NCT00079482 AML

German English

Eligibility AML NCT00079482

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00079482
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
cytological confirmation of AML
Description

AML

Data type

boolean

Alias
UMLS CUI-1
C0023467
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

Alias
UMLS CUI-1
C0277556
confirmation of FLT-3 activating mutation positive status after point of initial relapse
Description

FLT3 mutation

Data type

boolean

Alias
UMLS CUI-1
C2348501
aged 18 years or older
Description

Age

Data type

boolean

Alias
UMLS CUI-1
C0001779
no comorbid conditions that would limit life expectancy to less than 3 months
Description

Life expectancy

Data type

boolean

Alias
UMLS CUI-1
C0023671
ECOG Performance Score of 0, 1,or 2
Description

ECOG

Data type

boolean

Alias
UMLS CUI-1
C1828127
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

Not pregnant nor lactating

Data type

boolean

Alias
UMLS CUI-1
C0232973
UMLS CUI-2
C1518422
UMLS CUI-3
C0006147
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
bilirubin > 2x ULN
Description

Bilirubin

Data type

boolean

Alias
UMLS CUI-1
C0201913
ALT/AST > 3x ULN
Description

ALT and AST

Data type

boolean

Alias
UMLS CUI-1
C0001899
UMLS CUI-2
C0004002
serum creatinine > 1.5 mg/dL
Description

Serum creatinine

Data type

boolean

Alias
UMLS CUI-1
C0201976
resting ejection fraction of left ventricle < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC))
Description

Ejection fraction (EF)

Data type

boolean

Alias
UMLS CUI-1
C0232174
untreated or progressive infection
Description

Infection

Data type

boolean

Alias
UMLS CUI-1
C0009450
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

Alias
UMLS CUI-1
C0449389
any previous treatment with a FLT-3 inhibitor
Description

FLT3 inhibitor treatment

Data type

boolean

Alias
UMLS CUI-1
C0013227
UMLS CUI-2
CL414898
UMLS CUI-3
C1333568
requires current treatment for HIV with protease inhibitors
Description

HIV treatment

Data type

boolean

Alias
UMLS CUI-1
C0019693
active GI ulceration or bleeding
Description

Gastrointestinal ulceration or bleeding

Data type

boolean

Alias
UMLS CUI-1
C0237938
UMLS CUI-2
C0017181
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

Alias
UMLS CUI-1
C1516879
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Similar models

Eligibility AML NCT00079482

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility AML NCT00079482
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
AML
Item
cytological confirmation of AML
boolean
C0023467 (UMLS CUI-1)
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
C0277556 (UMLS CUI-1)
FLT3 mutation
Item
confirmation of FLT-3 activating mutation positive status after point of initial relapse
boolean
C2348501 (UMLS CUI-1)
Age
Item
aged 18 years or older
boolean
C0001779 (UMLS CUI-1)
Life expectancy
Item
no comorbid conditions that would limit life expectancy to less than 3 months
boolean
C0023671 (UMLS CUI-1)
ECOG
Item
ECOG Performance Score of 0, 1,or 2
boolean
C1828127 (UMLS CUI-1)
Not pregnant nor lactating
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
C0232973 (UMLS CUI-1)
C1518422 (UMLS CUI-2)
C0006147 (UMLS CUI-3)
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
Bilirubin
Item
bilirubin > 2x ULN
boolean
C0201913 (UMLS CUI-1)
ALT and AST
Item
ALT/AST > 3x ULN
boolean
C0001899 (UMLS CUI-1)
C0004002 (UMLS CUI-2)
Serum creatinine
Item
serum creatinine > 1.5 mg/dL
boolean
C0201976 (UMLS CUI-1)
Ejection fraction (EF)
Item
resting ejection fraction of left ventricle < 45% (applies only to patients scheduled to receive mitoxantrone, etoposide, and cytarabine (MEC))
boolean
C0232174 (UMLS CUI-1)
Infection
Item
untreated or progressive infection
boolean
C0009450 (UMLS CUI-1)
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
C0449389 (UMLS CUI-1)
FLT3 inhibitor treatment
Item
any previous treatment with a FLT-3 inhibitor
boolean
C0013227 (UMLS CUI-1)
CL414898 (UMLS CUI-2)
C1333568 (UMLS CUI-3)
HIV treatment
Item
requires current treatment for HIV with protease inhibitors
boolean
C0019693 (UMLS CUI-1)
Gastrointestinal ulceration or bleeding
Item
active GI ulceration or bleeding
boolean
C0237938 (UMLS CUI-1)
C0017181 (UMLS CUI-2)
Other investigational drug
Item
use of an investigational drug that is not expected to be cleared by the start of CEP-701 treatment
boolean
C1516879 (UMLS CUI-1)
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