ID

15033

Description

Topical SGX301 (Synthetic Hypericin) for the Treatment of Cutaneous T-Cell Lymphoma (Mycosis Fungoides); ODM derived from: https://clinicaltrials.gov/show/NCT02448381

Link

https://clinicaltrials.gov/show/NCT02448381

Keywords

Versions (1)
  1. 5/12/16 5/12/16 -
Uploaded on

May 12, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Cutaneous T-Cell Lymphoma NCT02448381

English

Eligibility Cutaneous T-Cell Lymphoma NCT02448381

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must have a clinical diagnosis of ctcl (mycosis fungoides), stage ia, stage ib, or stage iia.
Description

Lymphoma, T-Cell, Cutaneous | Mycosis Fungoides | Mycosis fungoides stage I | Mycosis fungoides stage II

Data type

boolean

Alias
UMLS CUI [1]
C0079773
UMLS CUI [2]
C0026948
UMLS CUI [3]
C0278567
UMLS CUI [4]
C0278569
subjects must have a minimum of three (3) evaluable, discrete lesions.
Description

Lesion Separate | Minimum Three

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0443299
UMLS CUI [2,1]
C1524031
UMLS CUI [2,2]
C0205449
subjects must be willing to refrain from sunbathing for the duration of the study.
Description

Willing Abstinence Sunbathing

Data type

boolean

Alias
UMLS CUI [1,1]
C0600109
UMLS CUI [1,2]
C3843422
UMLS CUI [1,3]
C0038813
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, sjögren's syndrome, xeroderma pigmentosum, and melanoma, or polymorphous light or radiation therapy within 30 days of enrolling.
Description

Hypersensitivity Sunlight | Dermatitis, Phototoxic | Porphyria | Lupus Erythematosus, Systemic | Sjogren's Syndrome | Xeroderma Pigmentosum | Melanoma | Therapeutic procedure Polymorphous light eruption | Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0038817
UMLS CUI [2]
C0162830
UMLS CUI [3]
C3463940
UMLS CUI [4]
C0024141
UMLS CUI [5]
C1527336
UMLS CUI [6]
C0043346
UMLS CUI [7]
C0025202
UMLS CUI [8,1]
C0087111
UMLS CUI [8,2]
C0031736
UMLS CUI [9]
C1522449
pregnancy or mothers who are breast feeding.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
males and females not willing to use effective contraception.
Description

Unwilling Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C0558080
UMLS CUI [1,2]
C0700589
unhealed sunburn.
Description

Sunburn Healed

Data type

boolean

Alias
UMLS CUI [1,1]
C0038814
UMLS CUI [1,2]
C0205249
subjects receiving systemic or topical steroids, nitrogen mustard, psoralen uva radiation therapy (puva), or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment.
Description

systemic steroids | Topical steroids | Mechlorethamine | PUVA Photochemotherapy | Carmustine | Systemic therapy Lymphoma, T-Cell, Cutaneous

Data type

boolean

Alias
UMLS CUI [1]
C2825233
UMLS CUI [2]
C2064827
UMLS CUI [3]
C0025033
UMLS CUI [4]
C0853073
UMLS CUI [5]
C0007257
UMLS CUI [6,1]
C1515119
UMLS CUI [6,2]
C0079773
subjects with significant history of systemic immunosuppression due to drugs or infection with hiv or htlv 1.
Description

Decreased Immunologic Activity Due to Pharmaceutical Preparations | Decreased Immunologic Activity Due to HIV Infections | Decreased Immunologic Activity Due to Human T-lymphotropic virus 1

Data type

boolean

Alias
UMLS CUI [1,1]
C1373218
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0013227
UMLS CUI [2,1]
C1373218
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0019693
UMLS CUI [3,1]
C1373218
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0020094
subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
Description

Investigational New Drugs Other | Drug abuse

Data type

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0205394
UMLS CUI [2]
C0013146
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Similar models

Eligibility Cutaneous T-Cell Lymphoma NCT02448381

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Lymphoma, T-Cell, Cutaneous | Mycosis Fungoides | Mycosis fungoides stage I | Mycosis fungoides stage II
Item
subjects must have a clinical diagnosis of ctcl (mycosis fungoides), stage ia, stage ib, or stage iia.
boolean
C0079773 (UMLS CUI [1])
C0026948 (UMLS CUI [2])
C0278567 (UMLS CUI [3])
C0278569 (UMLS CUI [4])
Lesion Separate | Minimum Three
Item
subjects must have a minimum of three (3) evaluable, discrete lesions.
boolean
C0221198 (UMLS CUI [1,1])
C0443299 (UMLS CUI [1,2])
C1524031 (UMLS CUI [2,1])
C0205449 (UMLS CUI [2,2])
Willing Abstinence Sunbathing
Item
subjects must be willing to refrain from sunbathing for the duration of the study.
boolean
C0600109 (UMLS CUI [1,1])
C3843422 (UMLS CUI [1,2])
C0038813 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hypersensitivity Sunlight | Dermatitis, Phototoxic | Porphyria | Lupus Erythematosus, Systemic | Sjogren's Syndrome | Xeroderma Pigmentosum | Melanoma | Therapeutic procedure Polymorphous light eruption | Therapeutic radiology procedure
Item
history of sun hypersensitivity and photosensitive dermatoses including porphyria, systemic lupus erythematosus, sjögren's syndrome, xeroderma pigmentosum, and melanoma, or polymorphous light or radiation therapy within 30 days of enrolling.
boolean
C0020517 (UMLS CUI [1,1])
C0038817 (UMLS CUI [1,2])
C0162830 (UMLS CUI [2])
C3463940 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C1527336 (UMLS CUI [5])
C0043346 (UMLS CUI [6])
C0025202 (UMLS CUI [7])
C0087111 (UMLS CUI [8,1])
C0031736 (UMLS CUI [8,2])
C1522449 (UMLS CUI [9])
Pregnancy | Breast Feeding
Item
pregnancy or mothers who are breast feeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Unwilling Contraceptive methods
Item
males and females not willing to use effective contraception.
boolean
C0558080 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Sunburn Healed
Item
unhealed sunburn.
boolean
C0038814 (UMLS CUI [1,1])
C0205249 (UMLS CUI [1,2])
systemic steroids | Topical steroids | Mechlorethamine | PUVA Photochemotherapy | Carmustine | Systemic therapy Lymphoma, T-Cell, Cutaneous
Item
subjects receiving systemic or topical steroids, nitrogen mustard, psoralen uva radiation therapy (puva), or carmustine (bcnu) or other systemic therapies for ctcl within 3 weeks of enrollment.
boolean
C2825233 (UMLS CUI [1])
C2064827 (UMLS CUI [2])
C0025033 (UMLS CUI [3])
C0853073 (UMLS CUI [4])
C0007257 (UMLS CUI [5])
C1515119 (UMLS CUI [6,1])
C0079773 (UMLS CUI [6,2])
Decreased Immunologic Activity Due to Pharmaceutical Preparations | Decreased Immunologic Activity Due to HIV Infections | Decreased Immunologic Activity Due to Human T-lymphotropic virus 1
Item
subjects with significant history of systemic immunosuppression due to drugs or infection with hiv or htlv 1.
boolean
C1373218 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C1373218 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0019693 (UMLS CUI [2,3])
C1373218 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0020094 (UMLS CUI [3,3])
Investigational New Drugs Other | Drug abuse
Item
subjects taking other investigational drugs or drugs of abuse within 30 days of entry into this study.
boolean
C0013230 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0013146 (UMLS CUI [2])
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