0 Ratings
ID

17245

Description

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

Link

https://clinicaltrials.gov/show/NCT00514475

Keywords

Versions (1)
  1. 9/1/16 9/1/16 -
Uploaded on

September 1, 2016

DOI

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License

Creative Commons BY 4.0
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    Eligibility Mantle Cell Lymphoma NCT00514475

    English

    Eligibility Mantle Cell Lymphoma NCT00514475

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

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

    Age

    Data type

    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.
    Description

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

    Data type

    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.
    Description

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

    Data type

    boolean

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

    WHO performance status

    Data type

    boolean

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

    Life expectancy

    Data type

    boolean

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

    Informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

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

    Cardiac function

    Data type

    boolean

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

    Impaired liver, renal or other organ function

    Data type

    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
    Description

    Pregnancy/lactation

    Data type

    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.
    Description

    Contraceptive methods

    Data type

    boolean

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

    HIV

    Data type

    boolean

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

    Malignancy

    Data type

    boolean

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

    Seropositivity for hcv, hbsag or other active infection

    Data type

    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.
    Description

    psychiatric illness

    Data type

    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 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    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])
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