ID

42640

Beskrivning

A Study for Patients With Relapsed Cutaneous T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00744991

Länk

https://clinicaltrials.gov/show/NCT00744991

Nyckelord

Versioner (2)
  1. 2018-02-05 2018-02-05 -
  2. 2021-09-17 2021-09-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 september 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cutaneous T-Cell Lymphoma NCT00744991

Engelsk

Eligibility Cutaneous T-Cell Lymphoma NCT00744991

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
histologically confirmed mycosis fungoides or sezary syndrome
Beskrivning

Mycosis Fungoides | Sezary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0026948
UMLS CUI [2]
C0036920
stage ib to ivb disease at screening
Beskrivning

Disease Ann Arbor lymphoma staging system

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0432516
recurrent or refractory disease after at least 1 prior systemic therapy
Beskrivning

Recurrent disease | Refractory Disease | Status post Systemic therapy Quantity

Datatyp

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1515119
UMLS CUI [3,3]
C1265611
have adequate organ function defined as:
Beskrivning

Organ function

Datatyp

boolean

Alias
UMLS CUI [1]
C0678852
at least 30 days must have passed since other treatment for ctcl.
Beskrivning

Therapeutic procedure Cutaneous T-Cell Lymphoma | Requirement Elapsed Time

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079773
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C2826303
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
receiving concurrent treatment for ctcl
Beskrivning

Therapeutic procedure Cutaneous T-Cell Lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0079773
unable to swallow tablets
Beskrivning

Lacking Able to swallow Tablets

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712086
UMLS CUI [1,3]
C0039225
receiving high potency oral or topical steroids. low potency oral steroid may be permitted in patients who have been on a stable dose for at least 4 weeks prior to screening. oral or topical antihistamine is allowed.
Beskrivning

Steroids Oral High Potency | Topical steroids High Potency | Antihistamines Oral allowed | Topical antihistamine allowed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0038317
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C1656349
UMLS CUI [2,1]
C2064827
UMLS CUI [2,2]
C1656349
UMLS CUI [3,1]
C0019590
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0683607
UMLS CUI [4,1]
C0357949
UMLS CUI [4,2]
C0683607
unable to discontinue use of carbamazepine, phenobarbital, or phenytoin
Beskrivning

Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0006949
UMLS CUI [1,2]
C1444662
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C0031412
UMLS CUI [2,2]
C1444662
UMLS CUI [2,3]
C1299582
UMLS CUI [3,1]
C0031507
UMLS CUI [3,2]
C1444662
UMLS CUI [3,3]
C1299582
have a serious concomitant systemic disorder or hiv
Beskrivning

HIV Infection Systemic Serious

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0205373
UMLS CUI [1,3]
C0205404
have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the new york heart association (nyha) class iii or iv
Beskrivning

Cardiac problem Serious | Myocardial Infarction | Angina Pectoris | Heart Disease New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262402
UMLS CUI [1,2]
C0205404
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002962
UMLS CUI [4,1]
C0018799
UMLS CUI [4,2]
C1275491
have ecg abnormalities,
Beskrivning

ECG abnormality

Datatyp

boolean

Alias
UMLS CUI [1]
C0522055
are pregnant or breastfeeding
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Similar models

Eligibility Cutaneous T-Cell Lymphoma NCT00744991

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Mycosis Fungoides | Sezary Syndrome
Item
histologically confirmed mycosis fungoides or sezary syndrome
boolean
C0026948 (UMLS CUI [1])
C0036920 (UMLS CUI [2])
Disease Ann Arbor lymphoma staging system
Item
stage ib to ivb disease at screening
boolean
C0012634 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Recurrent disease | Refractory Disease | Status post Systemic therapy Quantity
Item
recurrent or refractory disease after at least 1 prior systemic therapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C0231290 (UMLS CUI [3,1])
C1515119 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Organ function
Item
have adequate organ function defined as:
boolean
C0678852 (UMLS CUI [1])
Therapeutic procedure Cutaneous T-Cell Lymphoma | Requirement Elapsed Time
Item
at least 30 days must have passed since other treatment for ctcl.
boolean
C0087111 (UMLS CUI [1,1])
C0079773 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C2826303 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Cutaneous T-Cell Lymphoma
Item
receiving concurrent treatment for ctcl
boolean
C0087111 (UMLS CUI [1,1])
C0079773 (UMLS CUI [1,2])
Lacking Able to swallow Tablets
Item
unable to swallow tablets
boolean
C0332268 (UMLS CUI [1,1])
C2712086 (UMLS CUI [1,2])
C0039225 (UMLS CUI [1,3])
Steroids Oral High Potency | Topical steroids High Potency | Antihistamines Oral allowed | Topical antihistamine allowed
Item
receiving high potency oral or topical steroids. low potency oral steroid may be permitted in patients who have been on a stable dose for at least 4 weeks prior to screening. oral or topical antihistamine is allowed.
boolean
C0038317 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C1656349 (UMLS CUI [1,3])
C2064827 (UMLS CUI [2,1])
C1656349 (UMLS CUI [2,2])
C0019590 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0357949 (UMLS CUI [4,1])
C0683607 (UMLS CUI [4,2])
Carbamazepine Discontinue Unable | Phenobarbital Discontinue Unable | Phenytoin Discontinue Unable
Item
unable to discontinue use of carbamazepine, phenobarbital, or phenytoin
boolean
C0006949 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0031412 (UMLS CUI [2,1])
C1444662 (UMLS CUI [2,2])
C1299582 (UMLS CUI [2,3])
C0031507 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
HIV Infection Systemic Serious
Item
have a serious concomitant systemic disorder or hiv
boolean
C0019693 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0205404 (UMLS CUI [1,3])
Cardiac problem Serious | Myocardial Infarction | Angina Pectoris | Heart Disease New York Heart Association Classification
Item
have a serious cardiac condition such as myocardial infarction within past 6 months, angina, or heart disease as defined by the new york heart association (nyha) class iii or iv
boolean
C0262402 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0027051 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0018799 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
ECG abnormality
Item
have ecg abnormalities,
boolean
C0522055 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
are pregnant or breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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