ID

16585

Description

Study of ONTAK® to Treat Cutaneous T-Cell Lymphoma (CTCL); ODM derived from: https://clinicaltrials.gov/show/NCT00211198

Link

https://clinicaltrials.gov/show/NCT00211198

Keywords

Versions (1)
  1. 7/25/16 7/25/16 -
Uploaded on

July 25, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Lymphoma, T-Cell, Cutaneous NCT00211198

English

Eligibility Lymphoma, T-Cell, Cutaneous NCT00211198

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
persistent or recurrent cutaneous t-cell lymphoma (ctcl) stage ib-iva as defined by tnm staging.
Description

cutaneous t-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079773
pathologic proven diagnosis (cytologically confirmed) of ctcl documented in patient history.
Description

cytologically confirmed

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C0205462
preserved organ function: creatinine and/or liver function levels <1.5 times institutional upper limits of normal (uln).
Description

kidney/liver function

Data type

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
adequate liver function as indicated by bilirubin < or equal to 1.5 times uln, alt < or equal to 2 times uln, ast < or equal to 2 times uln.
Description

adequate liver function

Data type

boolean

Alias
UMLS CUI [1]
C0201913
UMLS CUI [2]
C0201836
UMLS CUI [3]
C0201899
albumin >3.0 g/dl
Description

albumin

Data type

boolean

Alias
UMLS CUI [1]
C0201838
adequate renal function as indicated by scr < or equal to 2.5 mg/dl.
Description

renal function SCr

Data type

boolean

Alias
UMLS CUI [1]
C0201976
ecog performance status between 0-2.
Description

ecog performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
Description

pregnancy test and contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032976
UMLS CUI [2]
C0700589
patients over the age of 18 who are willing and able to provide informed consent.
Description

age and informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
pathology consistent with peripheral t-cell lymphoma.
Description

peripheral t-cell lymphoma

Data type

boolean

Alias
UMLS CUI [1]
C0079774
stage ivb (visceral involvement with ctcl, other than lymph node involvement).
Description

stage IVB

Data type

boolean

Alias
UMLS CUI [1]
C0854831
history of human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection.
Description

HIV, HBV, HCV

Data type

boolean

Alias
UMLS CUI [1]
C0019699
UMLS CUI [2]
C0149709
UMLS CUI [3]
C1112419
patients who are pregnant or breast feeding.
Description

pregnant or breast feeding

Data type

boolean

Alias
UMLS CUI [1,1]
C0549206
UMLS CUI [1,2]
C0006147
allergy to or have history of allergy to diphtheria toxin or il-2.
Description

allergy to diphtheria toxin or il-2

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0661882
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0021756
previous ontak® usage.
Description

previous ontak usage

Data type

boolean

Alias
UMLS CUI [1,1]
C2114648
UMLS CUI [1,2]
C0722264
unstable cardiovascular disease.
Description

unstable cardiovascular disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. exception: clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
Description

systemic or topical antineoplastic therapy or investigational medications

Data type

boolean

Alias
UMLS CUI [1]
C2346834
UMLS CUI [2]
C0013230
ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
Description

deep vein thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C0149871
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Similar models

Eligibility Lymphoma, T-Cell, Cutaneous NCT00211198

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
cutaneous t-cell lymphoma
Item
persistent or recurrent cutaneous t-cell lymphoma (ctcl) stage ib-iva as defined by tnm staging.
boolean
C0079773 (UMLS CUI [1])
cytologically confirmed
Item
pathologic proven diagnosis (cytologically confirmed) of ctcl documented in patient history.
boolean
C0011900 (UMLS CUI [1,1])
C0205462 (UMLS CUI [1,2])
kidney/liver function
Item
preserved organ function: creatinine and/or liver function levels <1.5 times institutional upper limits of normal (uln).
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
adequate liver function
Item
adequate liver function as indicated by bilirubin < or equal to 1.5 times uln, alt < or equal to 2 times uln, ast < or equal to 2 times uln.
boolean
C0201913 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
albumin
Item
albumin >3.0 g/dl
boolean
C0201838 (UMLS CUI [1])
renal function SCr
Item
adequate renal function as indicated by scr < or equal to 2.5 mg/dl.
boolean
C0201976 (UMLS CUI [1])
ecog performance status
Item
ecog performance status between 0-2.
boolean
C1520224 (UMLS CUI [1])
pregnancy test and contraceptive methods
Item
women of childbearing potential should be screened for pregnancy prior to treatment and utilize effective contraceptive methods (e.g. barrier) during treatment period.
boolean
C0032976 (UMLS CUI [1])
C0700589 (UMLS CUI [2])
age and informed consent
Item
patients over the age of 18 who are willing and able to provide informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
peripheral t-cell lymphoma
Item
pathology consistent with peripheral t-cell lymphoma.
boolean
C0079774 (UMLS CUI [1])
stage IVB
Item
stage ivb (visceral involvement with ctcl, other than lymph node involvement).
boolean
C0854831 (UMLS CUI [1])
HIV, HBV, HCV
Item
history of human immunodeficiency virus (hiv), hepatitis b or hepatitis c infection.
boolean
C0019699 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
C1112419 (UMLS CUI [3])
pregnant or breast feeding
Item
patients who are pregnant or breast feeding.
boolean
C0549206 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
allergy to diphtheria toxin or il-2
Item
allergy to or have history of allergy to diphtheria toxin or il-2.
boolean
C0020517 (UMLS CUI [1,1])
C0661882 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0021756 (UMLS CUI [2,2])
previous ontak usage
Item
previous ontak® usage.
boolean
C2114648 (UMLS CUI [1,1])
C0722264 (UMLS CUI [1,2])
unstable cardiovascular disease
Item
unstable cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
systemic or topical antineoplastic therapy or investigational medications
Item
patients who have received systemic or topical antineoplastic therapy or investigational medications within past 14 days. exception: clear evidence of disease progression requiring immediate intervention and in the absence of ongoing toxicity from prior therapy.
boolean
C2346834 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
deep vein thrombosis
Item
ongoing deep vein thrombosis or a diagnosis of deep vein thrombosis less than 3 months prior to protocol enrollment.
boolean
C0149871 (UMLS CUI [1])
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