0 Evaluaciones
ID

17245

Descripción

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

Palabras clave

Versiones (1)
  1. 1/9/16 1/9/16 -
Subido en

1 de septiembre de 2016

DOI

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Licencia

Creative Commons BY 4.0
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    Eligibility Mantle Cell Lymphoma NCT00514475

    Inglés

    Eligibility Mantle Cell Lymphoma NCT00514475

    1 formularios  
    Inclusion Criteria
    Descripción

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    1. age 18 - 65 years.
    Descripción

    Age

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0001779 (Age)
    SNOMED
    424144002
    LOINC
    LP28815-6
    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.
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0334634 (Malignant lymphoma, lymphocytic, intermediate differentiation, diffuse)
    SNOMED
    74654000
    UMLS CUI [2]
    C1300072 (Tumor stage)
    SNOMED
    371508000
    UMLS CUI [3]
    C3538992 (CD5 Expressing Cell Measurement)
    UMLS CUI [4]
    C3540684 (CD20 Expressing Cell Measurement)
    UMLS CUI [5]
    C0174680 (Cyclin D1)
    SNOMED
    66235009
    UMLS CUI [6]
    C1515705 (t(11;14)(q13;q32))
    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.
    Descripción

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

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1522449 (Therapeutic radiology procedure)
    SNOMED
    53438000
    LOINC
    LA4351-8
    UMLS CUI [2,1]
    C1302181 (Chemotherapy cycle)
    SNOMED
    399042005
    UMLS CUI [2,2]
    C0750480 (Count)
    4. who performance status of 0 - 3.
    Descripción

    WHO performance status

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C1298650 (WHO performance status scale)
    SNOMED
    373801008
    5. life expectancy of more than 3 months.
    Descripción

    Life expectancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0023671 (Life Expectancy)
    6. written informed consent.
    Descripción

    Informed consent

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Descripción

    Exclusion Criteria

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

    Cardiac function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    2. impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment.
    Descripción

    Impaired liver, renal or other organ function

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0232741 (Liver function)
    SNOMED
    79036002
    LOINC
    LP31397-0
    UMLS CUI [2]
    C0232804 (Renal function)
    SNOMED
    11953005
    LOINC
    LP31398-8
    UMLS CUI [3]
    C0232164 (Cardiac function)
    SNOMED
    86185002
    UMLS CUI [4,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [4,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [4,3]
    C0009488 (Comorbidity)
    3. pregnancy/lactation
    Descripción

    Pregnancy/lactation

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    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.
    Descripción

    Contraceptive methods

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    5. known hiv positivity
    Descripción

    HIV

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    6. any other prior malignancy than non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma.
    Descripción

    Malignancy

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0006826 (Malignant Neoplasms)
    SNOMED
    363346000
    LOINC
    LP100805-3
    7. known seropositivity for hcv, hbsag or other active infection uncontrolled by treatment.
    Descripción

    Seropositivity for hcv, hbsag or other active infection

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1]
    C0019196 (Hepatitis C)
    SNOMED
    50711007
    LOINC
    LA19423-5
    UMLS CUI [2]
    C0019168 (Hepatitis B Surface Antigens)
    SNOMED
    22290004
    LOINC
    LP38331-2
    UMLS CUI [3]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    8. psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
    Descripción

    psychiatric illness

    Tipo de datos

    boolean

    Alias
    UMLS CUI [1,1]
    C1321605 (Compliance behavior)
    SNOMED
    405078008
    UMLS CUI [1,2]
    C0439801 (Limited (extensiveness))
    SNOMED
    255469002
    LOINC
    LP34047-8
    UMLS CUI [1,3]
    C0004936 (Mental disorders)
    SNOMED
    74732009
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    Similar models

    Eligibility Mantle Cell Lymphoma NCT00514475

    1 formularios
    Name
    Tipo
    Description | Question | Decode (Coded Value)
    Tipo de datos
    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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