ID

4849

Description

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

Lien

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

Mots-clés

  1. 14/11/2011 14/11/2011 -
  2. 23/03/2014 23/03/2014 - Martin Dugas
  3. 11/04/2014 11/04/2014 - Julian Varghese
Téléchargé le

11 avril 2014

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

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Eligibility NCT00050999 T-Cell Lymphoma

Eligibility NCT00050999

  1. StudyEvent: Eligibility
    1. Eligibility NCT00050999
Inclusion criteria
Description

Inclusion criteria

Alias
UMLS CUI-1
C1512693
18 Years and older
Description

Age

Type de données

boolean

Alias
UMLS CUI-1
C0001779
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
Description

CTCL

Type de données

boolean

Alias
UMLS CUI-1
C0079773
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
Description

Prior CTCL therapy

Type de données

boolean

Alias
UMLS CUI-1
C0039798
UMLS CUI-2
C0079773
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
Description

Interleukin-2 receptor expression

Type de données

boolean

Alias
UMLS CUI-1
C0034819
UMLS CUI-2
C0017262
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.
Description

Disease stage

Type de données

boolean

Alias
UMLS CUI-1
C0699749
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
Description

Other diseases

Type de données

boolean

Alias
UMLS CUI-1
C2359476
Willingness to be randomized to a placebo treatment only arm
Description

Willingness

Type de données

boolean

Alias
UMLS CUI-1
C1516879
UMLS CUI-2
C0599724
ECOG performance status 0 or 1
Description

ECOG

Type de données

text

Alias
UMLS CUI-1
C1520224
Exclusion criteria
Description

Exclusion criteria

Alias
UMLS CUI-1
C0680251
Patients must not have previously received treatment with DAB389IL-2 or DAB486IL 2 (previous candidate compound evaluated in a clinical setting).
Description

Previous trials

Type de données

boolean

Alias
UMLS CUI-1
C2348568

Similar models

Eligibility NCT00050999

  1. StudyEvent: Eligibility
    1. Eligibility NCT00050999
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inclusion criteria
C1512693 (UMLS CUI-1)
Age
Item
18 Years and older
boolean
C0001779 (UMLS CUI-1)
CTCL
Item
Histopathologically confirmed recurrent or persistent CTCL as determined by reference pathology lab
boolean
C0079773 (UMLS CUI-1)
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
C0039798 (UMLS CUI-1)
C0079773 (UMLS CUI-2)
Interleukin-2 receptor expression
Item
Interleukin-2 receptor (IL-2R) expression on at least 20% of tumor cells as determined by immunohistochemistry
boolean
C0034819 (UMLS CUI-1)
C0017262 (UMLS CUI-2)
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
C0699749 (UMLS CUI-1)
Other diseases
Item
No active CNS disease, kidney or liver disease, significant pulmonary disease, or cardiac disease. No systemic infections
boolean
C2359476 (UMLS CUI-1)
Willingness
Item
Willingness to be randomized to a placebo treatment only arm
boolean
C1516879 (UMLS CUI-1)
C0599724 (UMLS CUI-2)
Item
ECOG performance status 0 or 1
text
C1520224 (UMLS CUI-1)
Code List
ECOG performance status 0 or 1
CL Item
ECOG 0 (0)
CL Item
ECOG 1 (1)
Item Group
Exclusion criteria
C0680251 (UMLS CUI-1)
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
C2348568 (UMLS CUI-1)

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