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ID

42354

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT01578499

Stichworte

Versionen (1)
  1. 22.06.21 22.06.21 -
Rechteinhaber

Millennium Pharmaceuticals, Inc. Seagen Inc.

Hochgeladen am

22. Juni 2021

DOI

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Lizenz

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

    Englisch

    Eligibility Primary Cutaneous Anaplastic Large Cell Lymphoma, NCT01578499

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    voluntary consent form
    Beschreibung

    Informed consent voluntary

    Datentyp

    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
    Beschreibung

    Age | Mucosis fungoides | Primary cutaneous anaplastic large cell lymphoma

    Datentyp

    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
    Beschreibung

    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

    Datentyp

    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
    Beschreibung

    CD30+ disease histologically confirmed

    Datentyp

    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
    Beschreibung

    Eastern cooperative oncology group (ecog) performance status

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Clinical laboratory values as specified in protocol

    Datentyp

    boolean

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

    Exclusion Criteria

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

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

    Datentyp

    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
    Beschreibung

    Cardiovascular conditions specified in study protocols

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Recent oral retinoid therapy

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

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

    Datentyp

    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
    Beschreibung

    Previous therapy with brentuximab vedotin

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2973446
    UMLS CUI [1,2]
    C2114510
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    Ähnliche Modelle

    Eligibility Primary Cutaneous Anaplastic Large Cell Lymphoma, NCT01578499

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    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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