ID
77
Beschrijving
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
Trefwoorden
Versies (3)
- 18-11-11 18-11-11 -
- 26-03-14 26-03-14 - Martin Dugas
- 17-09-21 17-09-21 -
Geüploaded op
18 november 2011
DOI
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Licentie
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00079482 AML
Eligibility
- StudyEvent: Eligibility
Beschrijving
Ausschlusskriterien
Beschrijving
Bilirubin
Datatype
boolean
Beschrijving
ALT / AST
Datatype
boolean
Beschrijving
Serum creatinine
Datatype
boolean
Beschrijving
Ejection fraction
Datatype
boolean
Beschrijving
Infection
Datatype
boolean
Beschrijving
Major physical or psychiatric condition
Datatype
boolean
Beschrijving
CNS involvement
Datatype
boolean
Beschrijving
Previous FLT-3 inhibitor
Datatype
boolean
Beschrijving
HIV treatment
Datatype
boolean
Beschrijving
Gastrointestinal ulceration or bleeding
Datatype
boolean
Beschrijving
Other investigational drug
Datatype
boolean
Beschrijving
Medizinische Konzepte
Beschrijving
Diagnosis
Datatype
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschrijving
AML
Datatype
string
Alias
- UMLS CUI
- C0023467
- SNOMED CT 2010_0731
- 91861009
- MedDRA 13.1
- 10000884
Beschrijving
Relapse
Datatype
string
Alias
- UMLS CUI
- C0035020
- SNOMED CT 2010_0731
- 263855007
- MedDRA 13.1
- 10000884
Beschrijving
FLT3 gene mutation analysis
Datatype
string
Alias
- UMLS CUI
- C1953284
Beschrijving
Age
Datatype
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschrijving
Compliance
Datatype
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Beschrijving
Life expectancy
Datatype
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Beschrijving
ECOG performance status
Datatype
string
Alias
- SNOMED CT 2010_0731
- 423740007
Beschrijving
pregnant
Datatype
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschrijving
Lactation
Datatype
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschrijving
Bilirubin
Datatype
string
Alias
- SNOMED CT 2010_0731
- 79706000
- UMLS CUI
- C0011221
- MedDRA Version 13.1
- 10004683
- LOINC
- 1975-2
Beschrijving
AST
Datatype
string
Alias
- SNOMED CT 2010_0731
- 26091008
- UMLS CUI
- C0004002
- MedDRA Version 13.1
- 10003543
- LOINC
- 1920-8
Beschrijving
ALT
Datatype
string
Alias
- SNOMED CT 2010_0731
- 56935002
- UMLS CUI
- C0001899
- MedDRA Version 13.1
- 10001844
- LOINC
- 1742-6
Beschrijving
Creatinine
Datatype
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Beschrijving
Cardiac ejection fraction
Datatype
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Beschrijving
Infection
Datatype
string
Alias
- UMLS CUI
- C0021311
- SNOMED CT 2010_0731
- 257551009
- MedDRA Version 13.1
- 10021789
Beschrijving
CNS involvement
Datatype
string
Alias
- UMLS CUI
- C0449389
- SNOMED CT 2010_0731
- 260766009
Beschrijving
Pharmaceutical Preparations
Datatype
string
Alias
- UMLS CUI
- C0013227
Beschrijving
HIV negative
Datatype
string
Alias
- UMLS CUI
- C0481430
- SNOMED CT 2010_0731
- 143223008
Beschrijving
Gastrointestinal ulcer
Datatype
string
Alias
- UMLS CUI
- C0237938
- SNOMED CT 2010_0731
- 40845000
- MedDRA Version 13.1
- 10061459
Beschrijving
Gastrointestinal hemorrhage
Datatype
string
Alias
- UMLS CUI
- C0017181
- SNOMED CT 2010_0731
- 74474003
- MedDRA Version 13.1
- 10017936
Beschrijving
Enrollment
Datatype
string
Alias
- UMLS CUI
- C1516879
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