ID

35631

Description

Therapeutic Efficacy of Topical Sirolimus in Early Stage Cutaneous T-cell Lymphoma (CTCL); ODM derived from: https://clinicaltrials.gov/show/NCT01843998

Link

https://clinicaltrials.gov/show/NCT01843998

Keywords

Versions (1)
  1. 3/13/19 3/13/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 13, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Cutaneous T-cell Lymphoma (CTCL) NCT01843998

English

Eligibility Cutaneous T-cell Lymphoma (CTCL) NCT01843998

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinically and histologically confirmed diagnosis of ctcl (early stage disease with patches and/or thin plaques covering up to 10%, stage ia)
Description

Cutaneous T-Cell Lymphoma Ann Arbor lymphoma staging system

Data type

boolean

Alias
UMLS CUI [1,1]
C0079773
UMLS CUI [1,2]
C0432516
relapsed or refractory disease after at least one standard skin directed treatment including corticosteroids, topical bexarotene, phototherapy
Description

Recurrent disease | Refractory Disease | Standard therapy Skin | Adrenal Cortex Hormones | Bexarotene Topical Product | Phototherapy

Data type

boolean

Alias
UMLS CUI [1]
C0277556
UMLS CUI [2]
C1514815
UMLS CUI [3,1]
C2936643
UMLS CUI [3,2]
C1123023
UMLS CUI [4]
C0001617
UMLS CUI [5]
C3215536
UMLS CUI [6]
C0031765
all subjects must be 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
life expectancy ≥ 6 months, determined by the treating physician
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
signed informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including topical or systemic glucocorticosteroids, chemotherapy, radiation therapy, antibody based therapy, etc.)
Description

Cancer treatment | Topical glucocorticoid | Glucocorticoids, Systemic | Chemotherapy | Therapeutic radiology procedure | Antibody therapy

Data type

boolean

Alias
UMLS CUI [1]
C0920425
UMLS CUI [2]
C0017712
UMLS CUI [3]
C3540777
UMLS CUI [4]
C0392920
UMLS CUI [5]
C1522449
UMLS CUI [6]
C0281176
prior treatment with any investigational drug within the preceding 4 weeks
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
Description

Systemic therapy chronic | Adrenal Cortex Hormones | Immunosuppressive Agents

Data type

boolean

Alias
UMLS CUI [1,1]
C1515119
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0001617
UMLS CUI [3]
C0021081
female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. adequate contraception (oral contraceptives ("the pill"), intrauterine devices (iuds), contraceptive implants under the skin, or contraceptive injections, diaphragms with spermicide and condoms with foam) must be used throughout the trial and for 8 weeks after the last dose of study drug (women of childbearing potential must have a negative urine within 7 days prior to administration of sirolimus).
Description

Pregnancy | Breast Feeding | Adult Females & males of reproductive potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant | Contraceptive injection | Vaginal contraceptive diaphragm | Vaginal Spermicides | Condoms | Spermicidal Foam | Childbearing Potential Urine pregnancy test negative

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0001675
UMLS CUI [3,2]
C4034483
UMLS CUI [3,3]
C0700589
UMLS CUI [3,4]
C0332197
UMLS CUI [4]
C0009905
UMLS CUI [5]
C0021900
UMLS CUI [6]
C1657106
UMLS CUI [7]
C1656586
UMLS CUI [8]
C0042241
UMLS CUI [9]
C0087145
UMLS CUI [10]
C0677582
UMLS CUI [11]
C2985329
UMLS CUI [12,1]
C3831118
UMLS CUI [12,2]
C0430057
patients who have received prior treatment with an mtor inhibitor (e.g., sirolimus, temsirolimus, everolimus).
Description

mTOR Inhibitor | Sirolimus | temsirolimus | everolimus

Data type

boolean

Alias
UMLS CUI [1]
C2746052
UMLS CUI [2]
C0072980
UMLS CUI [3]
C1707080
UMLS CUI [4]
C0541315
patients with a known hypersensitivity to sirolimus or other rapamycin (e.g., everolimus, temsirolimus) or to its excipient
Description

Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Hypersensitivity Temsirolimus | Hypersensitivity Sirolimus Excipient | Hypersensitivity Everolimus Excipient | Hypersensitivity Temsirolimus Excipient

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0072980
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0541315
UMLS CUI [3,1]
C0020517
UMLS CUI [3,2]
C1707080
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0072980
UMLS CUI [4,3]
C0015237
UMLS CUI [5,1]
C0020517
UMLS CUI [5,2]
C0541315
UMLS CUI [5,3]
C0015237
UMLS CUI [6,1]
C0020517
UMLS CUI [6,2]
C1707080
UMLS CUI [6,3]
C0015237
history of noncompliance to medical regimens
Description

Noncompliance with regimen (medical)

Data type

boolean

Alias
UMLS CUI [1]
C1408343
patients unwilling to or unable to comply with the protocol
Description

Protocol Compliance Unwilling | Protocol Compliance Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Cutaneous T-cell Lymphoma (CTCL) NCT01843998

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cutaneous T-Cell Lymphoma Ann Arbor lymphoma staging system
Item
clinically and histologically confirmed diagnosis of ctcl (early stage disease with patches and/or thin plaques covering up to 10%, stage ia)
boolean
C0079773 (UMLS CUI [1,1])
C0432516 (UMLS CUI [1,2])
Recurrent disease | Refractory Disease | Standard therapy Skin | Adrenal Cortex Hormones | Bexarotene Topical Product | Phototherapy
Item
relapsed or refractory disease after at least one standard skin directed treatment including corticosteroids, topical bexarotene, phototherapy
boolean
C0277556 (UMLS CUI [1])
C1514815 (UMLS CUI [2])
C2936643 (UMLS CUI [3,1])
C1123023 (UMLS CUI [3,2])
C0001617 (UMLS CUI [4])
C3215536 (UMLS CUI [5])
C0031765 (UMLS CUI [6])
Age
Item
all subjects must be 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
life expectancy ≥ 6 months, determined by the treating physician
boolean
C0023671 (UMLS CUI [1])
Informed Consent
Item
signed informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cancer treatment | Topical glucocorticoid | Glucocorticoids, Systemic | Chemotherapy | Therapeutic radiology procedure | Antibody therapy
Item
patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug (including topical or systemic glucocorticosteroids, chemotherapy, radiation therapy, antibody based therapy, etc.)
boolean
C0920425 (UMLS CUI [1])
C0017712 (UMLS CUI [2])
C3540777 (UMLS CUI [3])
C0392920 (UMLS CUI [4])
C1522449 (UMLS CUI [5])
C0281176 (UMLS CUI [6])
Investigational New Drugs
Item
prior treatment with any investigational drug within the preceding 4 weeks
boolean
C0013230 (UMLS CUI [1])
Systemic therapy chronic | Adrenal Cortex Hormones | Immunosuppressive Agents
Item
patients receiving chronic, systemic treatment with corticosteroids or another immunosuppressive agent.
boolean
C1515119 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0001617 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
Pregnancy | Breast Feeding | Adult Females & males of reproductive potential Contraceptive methods Absent | Contraceptives, Oral | Intrauterine Devices | Contraceptive implant | Contraceptive injection | Vaginal contraceptive diaphragm | Vaginal Spermicides | Condoms | Spermicidal Foam | Childbearing Potential Urine pregnancy test negative
Item
female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. adequate contraception (oral contraceptives ("the pill"), intrauterine devices (iuds), contraceptive implants under the skin, or contraceptive injections, diaphragms with spermicide and condoms with foam) must be used throughout the trial and for 8 weeks after the last dose of study drug (women of childbearing potential must have a negative urine within 7 days prior to administration of sirolimus).
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0001675 (UMLS CUI [3,1])
C4034483 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C0332197 (UMLS CUI [3,4])
C0009905 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C1657106 (UMLS CUI [6])
C1656586 (UMLS CUI [7])
C0042241 (UMLS CUI [8])
C0087145 (UMLS CUI [9])
C0677582 (UMLS CUI [10])
C2985329 (UMLS CUI [11])
C3831118 (UMLS CUI [12,1])
C0430057 (UMLS CUI [12,2])
mTOR Inhibitor | Sirolimus | temsirolimus | everolimus
Item
patients who have received prior treatment with an mtor inhibitor (e.g., sirolimus, temsirolimus, everolimus).
boolean
C2746052 (UMLS CUI [1])
C0072980 (UMLS CUI [2])
C1707080 (UMLS CUI [3])
C0541315 (UMLS CUI [4])
Hypersensitivity Sirolimus | Hypersensitivity Everolimus | Hypersensitivity Temsirolimus | Hypersensitivity Sirolimus Excipient | Hypersensitivity Everolimus Excipient | Hypersensitivity Temsirolimus Excipient
Item
patients with a known hypersensitivity to sirolimus or other rapamycin (e.g., everolimus, temsirolimus) or to its excipient
boolean
C0020517 (UMLS CUI [1,1])
C0072980 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0541315 (UMLS CUI [2,2])
C0020517 (UMLS CUI [3,1])
C1707080 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0072980 (UMLS CUI [4,2])
C0015237 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C0541315 (UMLS CUI [5,2])
C0015237 (UMLS CUI [5,3])
C0020517 (UMLS CUI [6,1])
C1707080 (UMLS CUI [6,2])
C0015237 (UMLS CUI [6,3])
Noncompliance with regimen (medical)
Item
history of noncompliance to medical regimens
boolean
C1408343 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
patients unwilling to or unable to comply with the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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