ID
77
Beschreibung
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
Stichworte
Versionen (3)
- 18.11.11 18.11.11 -
- 26.03.14 26.03.14 - Martin Dugas
- 17.09.21 17.09.21 -
Hochgeladen am
18. November 2011
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0 Legacy
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Eligibility NCT00079482 AML
Eligibility
- StudyEvent: Eligibility
Beschreibung
Ausschlusskriterien
Beschreibung
Bilirubin
Datentyp
boolean
Beschreibung
ALT / AST
Datentyp
boolean
Beschreibung
Serum creatinine
Datentyp
boolean
Beschreibung
Ejection fraction
Datentyp
boolean
Beschreibung
Infection
Datentyp
boolean
Beschreibung
Major physical or psychiatric condition
Datentyp
boolean
Beschreibung
CNS involvement
Datentyp
boolean
Beschreibung
Previous FLT-3 inhibitor
Datentyp
boolean
Beschreibung
HIV treatment
Datentyp
boolean
Beschreibung
Gastrointestinal ulceration or bleeding
Datentyp
boolean
Beschreibung
Other investigational drug
Datentyp
boolean
Beschreibung
Medizinische Konzepte
Beschreibung
Diagnosis
Datentyp
string
Alias
- UMLS CUI
- C0011900
- SNOMED CT 2010_0731
- 439401001
Beschreibung
AML
Datentyp
string
Alias
- UMLS CUI
- C0023467
- SNOMED CT 2010_0731
- 91861009
- MedDRA 13.1
- 10000884
Beschreibung
Relapse
Datentyp
string
Alias
- UMLS CUI
- C0035020
- SNOMED CT 2010_0731
- 263855007
- MedDRA 13.1
- 10000884
Beschreibung
FLT3 gene mutation analysis
Datentyp
string
Alias
- UMLS CUI
- C1953284
Beschreibung
Age
Datentyp
string
Alias
- UMLS CUI
- C0001779
- SNOMED CT 2010_0731
- 102518004
Beschreibung
Compliance
Datentyp
string
Alias
- UMLS CUI
- C1321605
- SNOMED CT 2010_0731
- 405078008
Beschreibung
Life expectancy
Datentyp
string
Alias
- UMLS CUI
- C0023671
- LOINC Version 232
- LP75025-4
Beschreibung
ECOG performance status
Datentyp
string
Alias
- SNOMED CT 2010_0731
- 423740007
Beschreibung
pregnant
Datentyp
string
Alias
- UMLS CUI
- C0549206
- MedDRA 13.1
- 10036586
Beschreibung
Lactation
Datentyp
string
Alias
- UMLS CUI
- C0006147
- MedDRA 13.1
- 10006247
Beschreibung
Bilirubin
Datentyp
string
Alias
- SNOMED CT 2010_0731
- 79706000
- UMLS CUI
- C0011221
- MedDRA Version 13.1
- 10004683
- LOINC
- 1975-2
Beschreibung
AST
Datentyp
string
Alias
- SNOMED CT 2010_0731
- 26091008
- UMLS CUI
- C0004002
- MedDRA Version 13.1
- 10003543
- LOINC
- 1920-8
Beschreibung
ALT
Datentyp
string
Alias
- SNOMED CT 2010_0731
- 56935002
- UMLS CUI
- C0001899
- MedDRA Version 13.1
- 10001844
- LOINC
- 1742-6
Beschreibung
Creatinine
Datentyp
string
Alias
- UMLS CUI
- C0010294
- SNOMED CT 2010_0731
- 15373003
- LOINC
- 38483-4
- MedDRA 13.1
- 10011358
Beschreibung
Cardiac ejection fraction
Datentyp
string
Alias
- UMLS CUI
- C0232174
- SNOMED CT 2010_0731
- 70822001
Beschreibung
Infection
Datentyp
string
Alias
- UMLS CUI
- C0021311
- SNOMED CT 2010_0731
- 257551009
- MedDRA Version 13.1
- 10021789
Beschreibung
CNS involvement
Datentyp
string
Alias
- UMLS CUI
- C0449389
- SNOMED CT 2010_0731
- 260766009
Beschreibung
Pharmaceutical Preparations
Datentyp
string
Alias
- UMLS CUI
- C0013227
Beschreibung
HIV negative
Datentyp
string
Alias
- UMLS CUI
- C0481430
- SNOMED CT 2010_0731
- 143223008
Beschreibung
Gastrointestinal ulcer
Datentyp
string
Alias
- UMLS CUI
- C0237938
- SNOMED CT 2010_0731
- 40845000
- MedDRA Version 13.1
- 10061459
Beschreibung
Gastrointestinal hemorrhage
Datentyp
string
Alias
- UMLS CUI
- C0017181
- SNOMED CT 2010_0731
- 74474003
- MedDRA Version 13.1
- 10017936
Beschreibung
Enrollment
Datentyp
string
Alias
- UMLS CUI
- C1516879
Ähnliche Modelle
Eligibility
- StudyEvent: Eligibility
439401001 (SNOMED CT 2010_0731)
91861009 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
263855007 (SNOMED CT 2010_0731)
10000884 (MedDRA 13.1)
102518004 (SNOMED CT 2010_0731)
405078008 (SNOMED CT 2010_0731)
10036586 (MedDRA 13.1)
10006247 (MedDRA 13.1)
70822001 (SNOMED CT 2010_0731)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA Version 13.1)
260766009 (SNOMED CT 2010_0731)
143223008 (SNOMED CT 2010_0731)
40845000 (SNOMED CT 2010_0731)
10061459 (MedDRA Version 13.1)
74474003 (SNOMED CT 2010_0731)
10017936 (MedDRA Version 13.1)