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Information:
Fel:
ID
63
Beskrivning
ODM derived from http://clinicaltrials.gov/ct2/show/record/NCT00050999
Länk
http://clinicaltrials.gov/ct2/show/record/NCT00050999
Nyckelord
Versioner (3)
- 2011-11-14 2011-11-14 -
- 2014-03-23 2014-03-23 - Martin Dugas
- 2014-04-11 2014-04-11 - Julian Varghese
Uppladdad den
14 november 2011
DOI
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Licens
Creative Commons BY-NC 3.0 Legacy
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Eligibility NCT00050999 T-Cell Lymphoma
Similar models
Eligibility
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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
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
Age
Item
Age
string
C0001779 (UMLS CUI)
102518004 (SNOMED CT 2010_0731)
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)
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)
150415003 (SNOMED CT 2010_0731)
IL-2R
Item
Interleukin 2 Receptor
string
Tumor Staging
Item
Diagnostic Neoplasm Staging
string
Infection
Item
Infection
string
C0021311 (UMLS CUI)
257551009 (SNOMED CT 2010_0731)
10021789 (MedDRA 13.1)
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)
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)
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)
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)
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)
424122007 (SNOMED CT 2010_0731)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)