ID

4849

Descripción

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

Link

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

Palabras clave

  1. 14/11/11 14/11/11 -
  2. 23/3/14 23/3/14 - Martin Dugas
  3. 11/4/14 11/4/14 - Julian Varghese
Subido en

11 de abril de 2014

DOI

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Licencia

Creative Commons BY 4.0

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Eligibility NCT00050999 T-Cell Lymphoma

Eligibility NCT00050999

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

Inclusion criteria

Alias
UMLS CUI-1
C1512693
18 Years and older
Descripción

Age

Tipo de datos

boolean

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

CTCL

Tipo de datos

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
Descripción

Prior CTCL therapy

Tipo de datos

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
Descripción

Interleukin-2 receptor expression

Tipo de datos

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.
Descripción

Disease stage

Tipo de datos

boolean

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

Other diseases

Tipo de datos

boolean

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

Willingness

Tipo de datos

boolean

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

ECOG

Tipo de datos

text

Alias
UMLS CUI-1
C1520224
Exclusion criteria
Descripción

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).
Descripción

Previous trials

Tipo de datos

boolean

Alias
UMLS CUI-1
C2348568

Similar models

Eligibility NCT00050999

  1. StudyEvent: Eligibility
    1. Eligibility NCT00050999
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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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