ID

42354

Beskrivning

A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT01578499

Länk

https://clinicaltrials.gov/show/NCT01578499

Nyckelord

Versioner (1)
  1. 2021-06-22 2021-06-22 -
Rättsinnehavare

Millennium Pharmaceuticals, Inc. Seagen Inc.

Uppladdad den

22 juni 2021

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Primary Cutaneous Anaplastic Large Cell Lymphoma, NCT01578499

Engelsk

Eligibility Primary Cutaneous Anaplastic Large Cell Lymphoma, NCT01578499

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
voluntary consent form
Beskrivning

Informed consent voluntary

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0439656
male or female patients 18 years or older with diagnosis of mf or pcalcl
Beskrivning

Age | Mucosis fungoides | Primary cutaneous anaplastic large cell lymphoma

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001779
UMLS CUI [1,2]
C0026948
UMLS CUI [2,1]
C0001779
UMLS CUI [2,2]
C1301362
patients with pcalcl who have received prior radiation therapy or at least 1 prior systemic therapy; patients with mf who have received at least 1 prior systemic therapy
Beskrivning

Patients with pcalcl who have received prior radiation therapy or at least 1 prior systemic therapy | Patients with mf who have received at least 1 prior systemic therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301362
UMLS CUI [1,2]
C0279134
UMLS CUI [2,1]
C1301362
UMLS CUI [2,2]
C1515119
UMLS CUI [2,3]
C0332152
UMLS CUI [3,1]
C0026948
UMLS CUI [3,2]
C1515119
UMLS CUI [3,3]
C0332152
histologically confirmed cd30+ disease by central laboratory assessment and pathology review
Beskrivning

CD30+ disease histologically confirmed

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3888910
UMLS CUI [1,2]
C0750484
UMLS CUI [1,3]
C0030664
eastern cooperative oncology group (ecog) performance status ≤ 2
Beskrivning

Eastern cooperative oncology group (ecog) performance status

Datatyp

boolean

Alias
UMLS CUI [1]
C1520224
female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
Beskrivning

Postmenopausal state | Surgically sterile | Willing to practise 2 effective contraceptive methods | Willing to practise sexual abstinence

Datatyp

boolean

Alias
UMLS CUI [1]
C0232970
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C0600109
UMLS CUI [4,1]
C0036899
UMLS CUI [4,2]
C0600109
male patients who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
Beskrivning

Male patients willing to practice effective barrier contraception | Willing to practice true sexual abstinence

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004764
UMLS CUI [1,2]
C0086582
UMLS CUI [1,3]
C0600109
UMLS CUI [2,1]
C0036899
UMLS CUI [2,2]
C0086582
UMLS CUI [2,3]
C0600109
clinical laboratory values as specified in protocol
Beskrivning

Clinical laboratory values as specified in protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C1550543
UMLS CUI [1,3]
C0243161
UMLS CUI [1,4]
C2348563
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
a concurrent diagnosis of systemic alcl,other non hodgkin lymphoma(excluding lyp) or sezary syndrome or b2 disease
Beskrivning

Concurrent diagnosis of systemic aclc | Other non-hodgkin lymphoma | Sezary syndrome | B2 disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205420
UMLS CUI [1,2]
C1336548
UMLS CUI [2,1]
C0205420
UMLS CUI [2,2]
C0024305
UMLS CUI [3,1]
C0205420
UMLS CUI [3,2]
C0036920
UMLS CUI [4,1]
C0205420
UMLS CUI [4,2]
C0523880
patients with cardiovascular conditions specified in protocols
Beskrivning

Cardiovascular conditions specified in study protocols

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2348563
UMLS CUI [1,3]
C0449238
patients with history of another primary malignancy not in remission for at least 3 years
Beskrivning

History of another primary malignancy not in remission for at least 3 years

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0006826
UMLS CUI [1,3]
C0544452
UMLS CUI [1,4]
C0332197
known active cerebral/meningeal disease, hiv infection, hepatitis b or hepatitis c infection
Beskrivning

Known active cerebral/meningeal disease | HIV infection | Hepatitis B | Hepatitis C infection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0019693
UMLS CUI [1,2]
C0205177
UMLS CUI [2,1]
C0019163
UMLS CUI [2,2]
C0205177
UMLS CUI [3,1]
C0019196
UMLS CUI [3,2]
C0205177
UMLS CUI [4,1]
C0234387
UMLS CUI [4,2]
C0205177
UMLS CUI [5,1]
C0154728
UMLS CUI [5,2]
C0205177
oral retinoid therapy for any indication within 3 weeks of study entry
Beskrivning

Recent oral retinoid therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0442027
UMLS CUI [1,2]
C0035339
UMLS CUI [1,3]
C0087111
UMLS CUI [1,4]
C0332185
corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
Beskrivning

Corticosteroid therapy recent | Immunosuppresive chemotherapy recent | Antibody-directed immune therapy | Ammunoglobulin-based immune therapy

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0149783
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C3665472
UMLS CUI [2,2]
C0332185
UMLS CUI [3,1]
C0003250
UMLS CUI [3,2]
C0021083
UMLS CUI [3,3]
C0332185
UMLS CUI [4,1]
C0021027
UMLS CUI [4,2]
C1705938
UMLS CUI [4,3]
C0021083
UMLS CUI [4,4]
C0332185
female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 of any cycle
Beskrivning

Lactation and brestfeeding | Positive serum pregnancy test | Positive urine pregnancy test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0022925
UMLS CUI [1,2]
C0006147
UMLS CUI [2,1]
C0430064
UMLS CUI [2,2]
C1446409
UMLS CUI [3,1]
C0430056
UMLS CUI [3,2]
C1446409
previous receipt of brentuximab vedotin
Beskrivning

Previous therapy with brentuximab vedotin

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2973446
UMLS CUI [1,2]
C2114510
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Similar models

Eligibility Primary Cutaneous Anaplastic Large Cell Lymphoma, NCT01578499

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Informed consent voluntary
Item
voluntary consent form
boolean
C0021430 (UMLS CUI [1,1])
C0439656 (UMLS CUI [1,2])
Age | Mucosis fungoides | Primary cutaneous anaplastic large cell lymphoma
Item
male or female patients 18 years or older with diagnosis of mf or pcalcl
boolean
C0001779 (UMLS CUI [1,1])
C0026948 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2,1])
C1301362 (UMLS CUI [2,2])
Patients with pcalcl who have received prior radiation therapy or at least 1 prior systemic therapy | Patients with mf who have received at least 1 prior systemic therapy
Item
patients with pcalcl who have received prior radiation therapy or at least 1 prior systemic therapy; patients with mf who have received at least 1 prior systemic therapy
boolean
C1301362 (UMLS CUI [1,1])
C0279134 (UMLS CUI [1,2])
C1301362 (UMLS CUI [2,1])
C1515119 (UMLS CUI [2,2])
C0332152 (UMLS CUI [2,3])
C0026948 (UMLS CUI [3,1])
C1515119 (UMLS CUI [3,2])
C0332152 (UMLS CUI [3,3])
CD30+ disease histologically confirmed
Item
histologically confirmed cd30+ disease by central laboratory assessment and pathology review
boolean
C3888910 (UMLS CUI [1,1])
C0750484 (UMLS CUI [1,2])
C0030664 (UMLS CUI [1,3])
Eastern cooperative oncology group (ecog) performance status
Item
eastern cooperative oncology group (ecog) performance status ≤ 2
boolean
C1520224 (UMLS CUI [1])
Postmenopausal state | Surgically sterile | Willing to practise 2 effective contraceptive methods | Willing to practise sexual abstinence
Item
female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0600109 (UMLS CUI [3,3])
C0036899 (UMLS CUI [4,1])
C0600109 (UMLS CUI [4,2])
Male patients willing to practice effective barrier contraception | Willing to practice true sexual abstinence
Item
male patients who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
boolean
C0004764 (UMLS CUI [1,1])
C0086582 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
C0036899 (UMLS CUI [2,1])
C0086582 (UMLS CUI [2,2])
C0600109 (UMLS CUI [2,3])
Clinical laboratory values as specified in protocol
Item
clinical laboratory values as specified in protocol
boolean
C1254595 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C2348563 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Concurrent diagnosis of systemic aclc | Other non-hodgkin lymphoma | Sezary syndrome | B2 disease
Item
a concurrent diagnosis of systemic alcl,other non hodgkin lymphoma(excluding lyp) or sezary syndrome or b2 disease
boolean
C0205420 (UMLS CUI [1,1])
C1336548 (UMLS CUI [1,2])
C0205420 (UMLS CUI [2,1])
C0024305 (UMLS CUI [2,2])
C0205420 (UMLS CUI [3,1])
C0036920 (UMLS CUI [3,2])
C0205420 (UMLS CUI [4,1])
C0523880 (UMLS CUI [4,2])
Cardiovascular conditions specified in study protocols
Item
patients with cardiovascular conditions specified in protocols
boolean
C0007222 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
History of another primary malignancy not in remission for at least 3 years
Item
patients with history of another primary malignancy not in remission for at least 3 years
boolean
C0262926 (UMLS CUI [1,1])
C0006826 (UMLS CUI [1,2])
C0544452 (UMLS CUI [1,3])
C0332197 (UMLS CUI [1,4])
Known active cerebral/meningeal disease | HIV infection | Hepatitis B | Hepatitis C infection
Item
known active cerebral/meningeal disease, hiv infection, hepatitis b or hepatitis c infection
boolean
C0019693 (UMLS CUI [1,1])
C0205177 (UMLS CUI [1,2])
C0019163 (UMLS CUI [2,1])
C0205177 (UMLS CUI [2,2])
C0019196 (UMLS CUI [3,1])
C0205177 (UMLS CUI [3,2])
C0234387 (UMLS CUI [4,1])
C0205177 (UMLS CUI [4,2])
C0154728 (UMLS CUI [5,1])
C0205177 (UMLS CUI [5,2])
Recent oral retinoid therapy
Item
oral retinoid therapy for any indication within 3 weeks of study entry
boolean
C0442027 (UMLS CUI [1,1])
C0035339 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Corticosteroid therapy recent | Immunosuppresive chemotherapy recent | Antibody-directed immune therapy | Ammunoglobulin-based immune therapy
Item
corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
boolean
C0149783 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C3665472 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
C0003250 (UMLS CUI [3,1])
C0021083 (UMLS CUI [3,2])
C0332185 (UMLS CUI [3,3])
C0021027 (UMLS CUI [4,1])
C1705938 (UMLS CUI [4,2])
C0021083 (UMLS CUI [4,3])
C0332185 (UMLS CUI [4,4])
Lactation and brestfeeding | Positive serum pregnancy test | Positive urine pregnancy test
Item
female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 of any cycle
boolean
C0022925 (UMLS CUI [1,1])
C0006147 (UMLS CUI [1,2])
C0430064 (UMLS CUI [2,1])
C1446409 (UMLS CUI [2,2])
C0430056 (UMLS CUI [3,1])
C1446409 (UMLS CUI [3,2])
Previous therapy with brentuximab vedotin
Item
previous receipt of brentuximab vedotin
boolean
C2973446 (UMLS CUI [1,1])
C2114510 (UMLS CUI [1,2])
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