ID

24749

Description

Allogenic Stem Cell Transplantation (SCT) With Non-Myeloablative Conditioning in Patients With Relapse Non-Hodgkin's Lymphoma (NHL); ODM derived from: https://clinicaltrials.gov/show/NCT00644371

Link

https://clinicaltrials.gov/show/NCT00644371

Keywords

Versions (1)
  1. 8/16/17 8/16/17 -
Uploaded on

August 16, 2017

DOI

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License

Creative Commons BY 4.0
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    Eligibility Non-Hodgkin Lymphoma NCT00644371

    English

    Eligibility Non-Hodgkin Lymphoma NCT00644371

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. written informed consent
    Description

    Informed Consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    2. histologically confirmed b-cell lymphoma of the following subtypes:
    Description

    B-Cell Lymphoma Subtype

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079731
    UMLS CUI [1,2]
    C0449560
    lbcdl
    Description

    Diffuse Large B-Cell Lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0079744
    grade 3b follicular lymphoma
    Description

    Follicular Lymphoma Ann Arbor lymphoma staging system

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024301
    UMLS CUI [1,2]
    C0432516
    mantle-cell lymphoma
    Description

    Mantle-cell lymphoma

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0334634
    transformed b-cell lymphoma
    Description

    B-Cell Lymphoma Transformation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079731
    UMLS CUI [1,2]
    C1536010
    burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
    Description

    Burkitt Lymphoma | Patient Inappropriate Allogeneic Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006413
    UMLS CUI [2,1]
    C0030705
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [2,3]
    C0040739
    3. high-risk b-cell cd20+ lymphoma defined by
    Description

    B-Cell Lymphoma CD20 positive High risk of

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0079731
    UMLS CUI [1,2]
    C0882818
    UMLS CUI [1,3]
    C0332167
    having attained less than pr after two chemotherapy lines
    Description

    Chemotherapy cycle Quantity | Partial response Less Than

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C1302181
    UMLS CUI [1,2]
    C1265611
    UMLS CUI [2,1]
    C1521726
    UMLS CUI [2,2]
    C0439092
    post-transplantation relapse
    Description

    Recurrent disease Post Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0277556
    UMLS CUI [1,2]
    C0687676
    UMLS CUI [1,3]
    C0040732
    presence of disease detected through a metabolic approach (pet/ct or else ct+pet) either before or after autologous transplantation
    Description

    Disease detection PET/CT Before Autologous Transplantation | Disease detection CT Before Autologous Transplantation | Disease detection PET Before Autologous Transplantation | Disease detection PET/CT Post Autologous Transplantation | Disease detection CT Post Autologous Transplantation | Disease detection PET Post Autologous Transplantation

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0683509
    UMLS CUI [1,2]
    C1699633
    UMLS CUI [1,3]
    C0332152
    UMLS CUI [1,4]
    C0040736
    UMLS CUI [2,1]
    C0683509
    UMLS CUI [2,2]
    C0040405
    UMLS CUI [2,3]
    C0332152
    UMLS CUI [2,4]
    C0040736
    UMLS CUI [3,1]
    C0683509
    UMLS CUI [3,2]
    C0032743
    UMLS CUI [3,3]
    C0332152
    UMLS CUI [3,4]
    C0040736
    UMLS CUI [4,1]
    C0683509
    UMLS CUI [4,2]
    C1699633
    UMLS CUI [4,3]
    C0687676
    UMLS CUI [4,4]
    C0040736
    UMLS CUI [5,1]
    C0683509
    UMLS CUI [5,2]
    C0040405
    UMLS CUI [5,3]
    C0687676
    UMLS CUI [5,4]
    C0040736
    UMLS CUI [6,1]
    C0683509
    UMLS CUI [6,2]
    C0032743
    UMLS CUI [6,3]
    C0687676
    UMLS CUI [6,4]
    C0040736
    inability to collect enough stem cells for autologous transplantation
    Description

    Transplantation, Autologous | Stem cell Collection Unable

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0040736
    UMLS CUI [2,1]
    C0038250
    UMLS CUI [2,2]
    C1516698
    UMLS CUI [2,3]
    C1299582
    4. stable disease at the time of transplantation
    Description

    Stable Disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0677946
    5. age between 18 and 65
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    6. performance status (ecog) ≤ 2
    Description

    ECOG performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    7. normal and suitable pulmonary function (dlco ≥ 30%)
    Description

    Pulmonary function | Carbon Monoxide Diffusing Capability Test

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0231921
    UMLS CUI [2]
    C1516251
    8. left ventricular ejection fraction (lvef) determined by ventriculography or echocardiogram ≥ 40%
    Description

    Left ventricular ejection fraction Ventriculography | Left ventricular ejection fraction Echocardiography

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0428772
    UMLS CUI [1,2]
    C0596683
    UMLS CUI [2,1]
    C0428772
    UMLS CUI [2,2]
    C0013516
    9. normal hepatic and renal function, with creatinine ≤ 2 mg/dl and bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x unl ; ast, alt ≤ 2.5 x unl (≤ 5 x unl if hepatic infiltration)
    Description

    Liver function | Renal function | Creatinine measurement, serum | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Infiltration Hepatic

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C0232804
    UMLS CUI [3]
    C0201976
    UMLS CUI [4]
    C1278039
    UMLS CUI [5]
    C0201850
    UMLS CUI [6]
    C0201899
    UMLS CUI [7]
    C0201836
    UMLS CUI [8,1]
    C0332448
    UMLS CUI [8,2]
    C0205054
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. prior treatment with radiopharmaceutical agents
    Description

    Radiopharmaceuticals

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0182638
    2. hiv-associated lymphoma
    Description

    Lymphoma, HIV-Related

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0085090
    3. presence of human anti-mouse antibodies (hama) or anti-chimeric antibodies (haca)
    Description

    Human anti-mouse antibody | Human antichimeric Ab

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1291910
    UMLS CUI [2]
    C1317433
    4. patient's inability to follow the protocol
    Description

    Protocol Compliance Unable

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0525058
    UMLS CUI [1,2]
    C1299582
    5. hypersensitivity to 90y-itritumomab tiuxetan
    Description

    Hypersensitivity yttrium-90-ibritumomab tiuxetan

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C1134535
    6. presence of severe pathologies that preclude chemotherapeutic treatment
    Description

    Pathology Severe Excludes Chemotherapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0677042
    UMLS CUI [1,2]
    C0205082
    UMLS CUI [1,3]
    C0332196
    UMLS CUI [1,4]
    C0392920
    7. pregnant women or pregnancy risk due to inappropriate contraceptive measures
    Description

    Pregnancy | Contraceptive methods Inappropriate | Pregnancy Risk

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2,1]
    C0700589
    UMLS CUI [2,2]
    C1548788
    UMLS CUI [3,1]
    C0032961
    UMLS CUI [3,2]
    C0035647
    8. breastfeeding women
    Description

    Breast Feeding

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0006147
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    Similar models

    Eligibility Non-Hodgkin Lymphoma NCT00644371

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Informed Consent
    Item
    1. written informed consent
    boolean
    C0021430 (UMLS CUI [1])
    B-Cell Lymphoma Subtype
    Item
    2. histologically confirmed b-cell lymphoma of the following subtypes:
    boolean
    C0079731 (UMLS CUI [1,1])
    C0449560 (UMLS CUI [1,2])
    Diffuse Large B-Cell Lymphoma
    Item
    lbcdl
    boolean
    C0079744 (UMLS CUI [1])
    Follicular Lymphoma Ann Arbor lymphoma staging system
    Item
    grade 3b follicular lymphoma
    boolean
    C0024301 (UMLS CUI [1,1])
    C0432516 (UMLS CUI [1,2])
    Mantle-cell lymphoma
    Item
    mantle-cell lymphoma
    boolean
    C0334634 (UMLS CUI [1])
    B-Cell Lymphoma Transformation
    Item
    transformed b-cell lymphoma
    boolean
    C0079731 (UMLS CUI [1,1])
    C1536010 (UMLS CUI [1,2])
    Burkitt Lymphoma | Patient Inappropriate Allogeneic Transplantation
    Item
    burkitt lymphoma in patients not eligible for a conventional allogeneic transplant
    boolean
    C0006413 (UMLS CUI [1])
    C0030705 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C0040739 (UMLS CUI [2,3])
    B-Cell Lymphoma CD20 positive High risk of
    Item
    3. high-risk b-cell cd20+ lymphoma defined by
    boolean
    C0079731 (UMLS CUI [1,1])
    C0882818 (UMLS CUI [1,2])
    C0332167 (UMLS CUI [1,3])
    Chemotherapy cycle Quantity | Partial response Less Than
    Item
    having attained less than pr after two chemotherapy lines
    boolean
    C1302181 (UMLS CUI [1,1])
    C1265611 (UMLS CUI [1,2])
    C1521726 (UMLS CUI [2,1])
    C0439092 (UMLS CUI [2,2])
    Recurrent disease Post Transplantation
    Item
    post-transplantation relapse
    boolean
    C0277556 (UMLS CUI [1,1])
    C0687676 (UMLS CUI [1,2])
    C0040732 (UMLS CUI [1,3])
    Disease detection PET/CT Before Autologous Transplantation | Disease detection CT Before Autologous Transplantation | Disease detection PET Before Autologous Transplantation | Disease detection PET/CT Post Autologous Transplantation | Disease detection CT Post Autologous Transplantation | Disease detection PET Post Autologous Transplantation
    Item
    presence of disease detected through a metabolic approach (pet/ct or else ct+pet) either before or after autologous transplantation
    boolean
    C0683509 (UMLS CUI [1,1])
    C1699633 (UMLS CUI [1,2])
    C0332152 (UMLS CUI [1,3])
    C0040736 (UMLS CUI [1,4])
    C0683509 (UMLS CUI [2,1])
    C0040405 (UMLS CUI [2,2])
    C0332152 (UMLS CUI [2,3])
    C0040736 (UMLS CUI [2,4])
    C0683509 (UMLS CUI [3,1])
    C0032743 (UMLS CUI [3,2])
    C0332152 (UMLS CUI [3,3])
    C0040736 (UMLS CUI [3,4])
    C0683509 (UMLS CUI [4,1])
    C1699633 (UMLS CUI [4,2])
    C0687676 (UMLS CUI [4,3])
    C0040736 (UMLS CUI [4,4])
    C0683509 (UMLS CUI [5,1])
    C0040405 (UMLS CUI [5,2])
    C0687676 (UMLS CUI [5,3])
    C0040736 (UMLS CUI [5,4])
    C0683509 (UMLS CUI [6,1])
    C0032743 (UMLS CUI [6,2])
    C0687676 (UMLS CUI [6,3])
    C0040736 (UMLS CUI [6,4])
    Transplantation, Autologous | Stem cell Collection Unable
    Item
    inability to collect enough stem cells for autologous transplantation
    boolean
    C0040736 (UMLS CUI [1])
    C0038250 (UMLS CUI [2,1])
    C1516698 (UMLS CUI [2,2])
    C1299582 (UMLS CUI [2,3])
    Stable Disease
    Item
    4. stable disease at the time of transplantation
    boolean
    C0677946 (UMLS CUI [1])
    Age
    Item
    5. age between 18 and 65
    boolean
    C0001779 (UMLS CUI [1])
    ECOG performance status
    Item
    6. performance status (ecog) ≤ 2
    boolean
    C1520224 (UMLS CUI [1])
    Pulmonary function | Carbon Monoxide Diffusing Capability Test
    Item
    7. normal and suitable pulmonary function (dlco ≥ 30%)
    boolean
    C0231921 (UMLS CUI [1])
    C1516251 (UMLS CUI [2])
    Left ventricular ejection fraction Ventriculography | Left ventricular ejection fraction Echocardiography
    Item
    8. left ventricular ejection fraction (lvef) determined by ventriculography or echocardiogram ≥ 40%
    boolean
    C0428772 (UMLS CUI [1,1])
    C0596683 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [2,1])
    C0013516 (UMLS CUI [2,2])
    Liver function | Renal function | Creatinine measurement, serum | Serum total bilirubin measurement | Alkaline phosphatase measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Infiltration Hepatic
    Item
    9. normal hepatic and renal function, with creatinine ≤ 2 mg/dl and bi ≤ 1.5 mg/dl, and alkaline phosphatase ≤ 2.5 x unl ; ast, alt ≤ 2.5 x unl (≤ 5 x unl if hepatic infiltration)
    boolean
    C0232741 (UMLS CUI [1])
    C0232804 (UMLS CUI [2])
    C0201976 (UMLS CUI [3])
    C1278039 (UMLS CUI [4])
    C0201850 (UMLS CUI [5])
    C0201899 (UMLS CUI [6])
    C0201836 (UMLS CUI [7])
    C0332448 (UMLS CUI [8,1])
    C0205054 (UMLS CUI [8,2])
    Item Group
    C0680251 (UMLS CUI)
    Radiopharmaceuticals
    Item
    1. prior treatment with radiopharmaceutical agents
    boolean
    C0182638 (UMLS CUI [1])
    Lymphoma, HIV-Related
    Item
    2. hiv-associated lymphoma
    boolean
    C0085090 (UMLS CUI [1])
    Human anti-mouse antibody | Human antichimeric Ab
    Item
    3. presence of human anti-mouse antibodies (hama) or anti-chimeric antibodies (haca)
    boolean
    C1291910 (UMLS CUI [1])
    C1317433 (UMLS CUI [2])
    Protocol Compliance Unable
    Item
    4. patient's inability to follow the protocol
    boolean
    C0525058 (UMLS CUI [1,1])
    C1299582 (UMLS CUI [1,2])
    Hypersensitivity yttrium-90-ibritumomab tiuxetan
    Item
    5. hypersensitivity to 90y-itritumomab tiuxetan
    boolean
    C0020517 (UMLS CUI [1,1])
    C1134535 (UMLS CUI [1,2])
    Pathology Severe Excludes Chemotherapy
    Item
    6. presence of severe pathologies that preclude chemotherapeutic treatment
    boolean
    C0677042 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    C0332196 (UMLS CUI [1,3])
    C0392920 (UMLS CUI [1,4])
    Pregnancy | Contraceptive methods Inappropriate | Pregnancy Risk
    Item
    7. pregnant women or pregnancy risk due to inappropriate contraceptive measures
    boolean
    C0032961 (UMLS CUI [1])
    C0700589 (UMLS CUI [2,1])
    C1548788 (UMLS CUI [2,2])
    C0032961 (UMLS CUI [3,1])
    C0035647 (UMLS CUI [3,2])
    Breast Feeding
    Item
    8. breastfeeding women
    boolean
    C0006147 (UMLS CUI [1])
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