ID

63

Beschreibung

ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00050999

Link

http://clinicaltrials.gov/ct2/show/record/NCT00050999

Stichworte

Versionen (3)
  1. 14.11.11 14.11.11 -
  2. 23.03.14 23.03.14 - Martin Dugas
  3. 11.04.14 11.04.14 - Julian Varghese
Hochgeladen am

14. November 2011

DOI

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Lizenz

Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00050999 T-Cell Lymphoma

Englisch

Eligibility

1 Formulare  
  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion
Beschreibung

Inclusion

18 Years and older
Beschreibung

Age

Datentyp

boolean

Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
Beschreibung

CTCL

Datentyp

boolean

Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
Beschreibung

Prior CTCL therapy

Datentyp

boolean

Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
Beschreibung

Interleukin-2 receptor expression

Datentyp

boolean

Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
Beschreibung

Disease stage

Datentyp

boolean

No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
Beschreibung

Other diseases

Datentyp

boolean

Willingness to be randomized to a placebo treatment only arm
Beschreibung

Willingness placebo

Datentyp

boolean

ECOG performance status 0 or 1
Beschreibung

ECOG

Datentyp

boolean

Exclusion
Beschreibung

Exclusion

Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Beschreibung

Previous trials

Datentyp

boolean

Medical concepts
Beschreibung

Medical concepts

Age
Beschreibung

Age

Datentyp

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
102518004
Diagnosis
Beschreibung

Diagnosis

Datentyp

string

Alias
UMLS CUI
C0011900
Lymphoma, T-Cell, Cutaneous
Beschreibung

CTCL

Datentyp

string

Alias
UMLS CUI
C0079773
SNOMED CT 2010_0731
28054005
MedDRA 13.1
10011677
Medication
Beschreibung

Pharmaceutical Preparations

Datentyp

string

Alias
UMLS CUI
C0013227
Chemotherapy
Beschreibung

Chemotherapy

Datentyp

string

Alias
UMLS CUI
C0392920
SNOMED CT 2010_0731
150415003
Interleukin 2 Receptor
Beschreibung

IL-2R

Datentyp

string

Alias
UMLS CUI
C0034819
SNOMED CT 2010_0731
112119008
LOINC Version 232
MTHU011559
Diagnostic Neoplasm Staging
Beschreibung

Tumor Staging

Datentyp

string

Alias
UMLS CUI
C0027646
SNOMED CT 2010_0731
254292007
LOINC Version 232
LP78422-0
Infection
Beschreibung

Infection

Datentyp

string

Alias
UMLS CUI
C0021311
SNOMED CT 2010_0731
257551009
MedDRA 13.1
10021789
CNS disorder
Beschreibung

CNS disease

Datentyp

string

Alias
UMLS CUI
C0007682
SNOMED CT 2010_0731
23853001
MedDRA 13.1
10007943
ICD-10-CM Version 2010
G96.9
Kidney Diseases
Beschreibung

Renal disease

Datentyp

string

Alias
UMLS CUI
C0022658
SNOMED CT 2010_0731
90708001
MedDRA 13.1
10029151
ICD-10-CM Version 2010
N18.9
Liver diseases
Beschreibung

Liver disorder

Datentyp

string

Alias
UMLS CUI
C0023895
SNOMED CT 2010_0731
235856003
MedDRA 13.1
10024670
ICD-10-CM Version 2010
K76.9
ICD-9-CM Version 2011
573.9
Lung diseases
Beschreibung

Pulmonary disease

Datentyp

string

Alias
UMLS CUI
C0024115
SNOMED CT 2010_0731
19829001
MedDRA 13.1
10025082
ICD-10-CM Version 2010
J98.4
Placebos
Beschreibung

Placebo

Datentyp

string

Alias
UMLS CUI
C0032042
ECOG performance status finding
Beschreibung

ECOG

Datentyp

string

Alias
UMLS CUI
C1828127
SNOMED CT 2010_0731
424122007
Enrollment
Beschreibung

Enrollment

Datentyp

string

Alias
UMLS CUI
C1516879
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Ähnliche Modelle

Eligibility

1 Formulare
  1. StudyEvent: Eligibility
    1. Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Inclusion
Age
Item
18 Years and older
boolean
CTCL
Item
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
boolean
Prior CTCL therapy
Item
Patient must have had 1 to 3 prior CTCL therapies. Repeated use of the same agent is considered to be 1 therapy unless it is part of a different combination regimen. Only 1 prior combination cytotoxic regimen is permitted. Topical or systemic steroids are not considered a therapy;
boolean
Interleukin-2 receptor expression
Item
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
boolean
Disease stage
Item
Stage IA - III disease and unlikely to progress during the first month on study. Life expectancy of at least 12 months. Measurable or evaluable disease. Lymph node involvement no greater than LN2. No CTCL involvement of bone marrow.
boolean
Other diseases
Item
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
boolean
Willingness placebo
Item
Willingness to be randomized to a placebo treatment only arm
boolean
ECOG
Item
ECOG performance status 0 or 1
boolean
Item Group
Exclusion
Previous trials
Item
Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
boolean
Item Group
Medical concepts
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
Diagnosis
Item
Diagnosis
string
C0011900 (UMLS CUI)
CTCL
Item
Lymphoma, T-Cell, Cutaneous
string
C0079773 (UMLS CUI)
28054005 (SNOMED CT 2010_0731)
10011677 (MedDRA 13.1)
Pharmaceutical Preparations
Item
Medication
string
C0013227 (UMLS CUI)
Chemotherapy
Item
Chemotherapy
string
C0392920 (UMLS CUI)
150415003 (SNOMED CT 2010_0731)
IL-2R
Item
Interleukin 2 Receptor
string
C0034819 (UMLS CUI)
112119008 (SNOMED CT 2010_0731)
MTHU011559 (LOINC Version 232)
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
C0027646 (UMLS CUI)
254292007 (SNOMED CT 2010_0731)
LP78422-0 (LOINC Version 232)
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
CNS disease
Item
CNS disorder
string
C0007682 (UMLS CUI)
23853001 (SNOMED CT 2010_0731)
10007943 (MedDRA 13.1)
G96.9 (ICD-10-CM Version 2010)
Renal disease
Item
Kidney Diseases
string
C0022658 (UMLS CUI)
90708001 (SNOMED CT 2010_0731)
10029151 (MedDRA 13.1)
N18.9 (ICD-10-CM Version 2010)
Liver disorder
Item
Liver diseases
string
C0023895 (UMLS CUI)
235856003 (SNOMED CT 2010_0731)
10024670 (MedDRA 13.1)
K76.9 (ICD-10-CM Version 2010)
573.9 (ICD-9-CM Version 2011)
Pulmonary disease
Item
Lung diseases
string
C0024115 (UMLS CUI)
19829001 (SNOMED CT 2010_0731)
10025082 (MedDRA 13.1)
J98.4 (ICD-10-CM Version 2010)
Placebo
Item
Placebos
string
C0032042 (UMLS CUI)
ECOG
Item
ECOG performance status finding
string
C1828127 (UMLS CUI)
424122007 (SNOMED CT 2010_0731)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Zum Seitenanfang zurückkehren 

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