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ID

17245

Beskrivning

Zevalin-BEAM/BEAC With Autologous Stem Cell Support as Consolidation in First Line Treatment of Mantle Cell Lymphoma; ODM derived from: https://clinicaltrials.gov/show/NCT00514475

Länk

https://clinicaltrials.gov/show/NCT00514475

Nyckelord

Versioner (1)
  1. 2016-09-01 2016-09-01 -
Uppladdad den

1 september 2016

DOI

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Creative Commons BY 4.0
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    Eligibility Mantle Cell Lymphoma NCT00514475

    Engelsk

    Eligibility Mantle Cell Lymphoma NCT00514475

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. age 18 - 65 years.
    Beskrivning

    Age

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. histologically confirmed (according to the who classification) mantle cell lymphoma stage ii-iv at time point of diagnosis. the diagnosis has to be confirmed by phenotypic expression of cd5, cd20 and cyclin-d1 and most cases will have t(11;14) translocation.
    Beskrivning

    Mantle cell lymphoma stage ii-iv, phenotypic expression of cd5, cd20 and cyclin-d1 and t(11;14) translocation in most cases

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0334634
    UMLS CUI [2]
    C1300072
    UMLS CUI [3]
    C3538992
    UMLS CUI [4]
    C3540684
    UMLS CUI [5]
    C0174680
    UMLS CUI [6]
    C1515705
    3. no previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase ii study who can be transferred to nlg-mcl-iii before evaluation at week 15.
    Beskrivning

    no previous treatment for lymphoma except radiotherapy or one cycle of any regimen

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1522449
    UMLS CUI [2,1]
    C1302181
    UMLS CUI [2,2]
    C0750480
    4. who performance status of 0 - 3.
    Beskrivning

    WHO performance status

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1298650
    5. life expectancy of more than 3 months.
    Beskrivning

    Life expectancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    6. written informed consent.
    Beskrivning

    Informed consent

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. severe cardiac disease: cardiac function grade 3-4 (appendix 1).
    Beskrivning

    Cardiac function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232164
    2. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
    Beskrivning

    Impaired liver, renal or other organ function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0232164
    UMLS CUI [4,1]
    C1321605
    UMLS CUI [4,2]
    C0439801
    UMLS CUI [4,3]
    C0009488
    3. pregnancy/lactation
    Beskrivning

    Pregnancy/lactation

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    4. men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
    Beskrivning

    Contraceptive methods

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0700589
    5. known hiv positivity
    Beskrivning

    HIV

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    6. any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
    Beskrivning

    Malignancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    7. known seropositivity for hcv, hbsag or other active infection uncontrolled by treatment.
    Beskrivning

    Seropositivity for hcv, hbsag or other active infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019196
    UMLS CUI [2]
    C0019168
    UMLS CUI [3]
    C0009450
    8. psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
    Beskrivning

    psychiatric illness

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605
    UMLS CUI [1,2]
    C0439801
    UMLS CUI [1,3]
    C0004936
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    Similar models

    Eligibility Mantle Cell Lymphoma NCT00514475

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. age 18 - 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    Mantle cell lymphoma stage ii-iv, phenotypic expression of cd5, cd20 and cyclin-d1 and t(11;14) translocation in most cases
    Item
    2. histologically confirmed (according to the who classification) mantle cell lymphoma stage ii-iv at time point of diagnosis. the diagnosis has to be confirmed by phenotypic expression of cd5, cd20 and cyclin-d1 and most cases will have t(11;14) translocation.
    boolean
    C0334634 (UMLS CUI [1])
    C1300072 (UMLS CUI [2])
    C3538992 (UMLS CUI [3])
    C3540684 (UMLS CUI [4])
    C0174680 (UMLS CUI [5])
    C1515705 (UMLS CUI [6])
    no previous treatment for lymphoma except radiotherapy or one cycle of any regimen
    Item
    3. no previous treatment for lymphoma except radiotherapy or one cycle of any regimen and except patients treated in the previous phase ii study who can be transferred to nlg-mcl-iii before evaluation at week 15.
    boolean
    C1522449 (UMLS CUI [1])
    C1302181 (UMLS CUI [2,1])
    C0750480 (UMLS CUI [2,2])
    WHO performance status
    Item
    4. who performance status of 0 - 3.
    boolean
    C1298650 (UMLS CUI [1])
    Life expectancy
    Item
    5. life expectancy of more than 3 months.
    boolean
    C0023671 (UMLS CUI [1])
    Informed consent
    Item
    6. written informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    Cardiac function
    Item
    1. severe cardiac disease: cardiac function grade 3-4 (appendix 1).
    boolean
    C0232164 (UMLS CUI [1])
    Impaired liver, renal or other organ function
    Item
    2. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C0232164 (UMLS CUI [3])
    C1321605 (UMLS CUI [4,1])
    C0439801 (UMLS CUI [4,2])
    C0009488 (UMLS CUI [4,3])
    Pregnancy/lactation
    Item
    3. pregnancy/lactation
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Contraceptive methods
    Item
    4. men or woman of reproductive potential not agreeing to use acceptable method of birth control during treatment and for six moths after completion of treatment.
    boolean
    C0700589 (UMLS CUI [1])
    HIV
    Item
    5. known hiv positivity
    boolean
    C0019699 (UMLS CUI [1])
    Malignancy
    Item
    6. any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
    boolean
    C0006826 (UMLS CUI [1])
    Seropositivity for hcv, hbsag or other active infection
    Item
    7. known seropositivity for hcv, hbsag or other active infection uncontrolled by treatment.
    boolean
    C0019196 (UMLS CUI [1])
    C0019168 (UMLS CUI [2])
    C0009450 (UMLS CUI [3])
    psychiatric illness
    Item
    8. psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
    boolean
    C1321605 (UMLS CUI [1,1])
    C0439801 (UMLS CUI [1,2])
    C0004936 (UMLS CUI [1,3])
    Tillbaka till toppen 

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