ID

17984

Description

Phase I Study of Sequential Cord Blood Transplants; ODM derived from: https://clinicaltrials.gov/show/NCT00299767

Lien

https://clinicaltrials.gov/show/NCT00299767

Mots-clés

  1. 13/10/2016 13/10/2016 -
Téléchargé le

13 octobre 2016

DOI

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Licence

Creative Commons BY 4.0

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    Eligibility Lymphoma NCT00299767

    Eligibility Lymphoma NCT00299767

    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00299767
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    disease status: nhl, hd, or mm refractory to chemotherapy or relapsed; cll rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to 2 chemotherapy regimens; aml or all in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
    Description

    Disease | Non-Hodgkin Lymphoma Chemotherapy refractory | Hodgkin Disease Chemotherapy refractory | Multiple Myeloma Chemotherapy refractory | Non-Hodgkin Lymphoma Recurrent disease | Hodgkin Disease Recurrent disease | Multiple Myeloma Recurrent disease | Chronic Lymphocytic Leukemia | Rai Staging System | Lymphocyte Doubling Time | Chronic Lymphocytic Leukemia Chemotherapy Quantity Resistant | Acute myeloid leukemia in remission | Acute lymphoid leukemia in remission | Cytogenetic Analysis adverse effects | Hematological Disease antecedent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0012634
    UMLS CUI [2,1]
    C0024305
    UMLS CUI [2,2]
    C0392920
    UMLS CUI [2,3]
    C0205269
    UMLS CUI [3,1]
    C0019829
    UMLS CUI [3,2]
    C0392920
    UMLS CUI [3,3]
    C0205269
    UMLS CUI [4,1]
    C0026764
    UMLS CUI [4,2]
    C0392920
    UMLS CUI [4,3]
    C0205269
    UMLS CUI [5,1]
    C0024305
    UMLS CUI [5,2]
    C0277556
    UMLS CUI [6,1]
    C0019829
    UMLS CUI [6,2]
    C0277556
    UMLS CUI [7,1]
    C0026764
    UMLS CUI [7,2]
    C0277556
    UMLS CUI [8]
    C0023434
    UMLS CUI [9]
    C1514715
    UMLS CUI [10,1]
    C0024264
    UMLS CUI [10,2]
    C2986483
    UMLS CUI [11,1]
    C0023434
    UMLS CUI [11,2]
    C0392920
    UMLS CUI [11,3]
    C1265611
    UMLS CUI [11,4]
    C0332325
    UMLS CUI [12]
    C0153886
    UMLS CUI [13]
    C0153876
    UMLS CUI [14,1]
    C0752095
    UMLS CUI [14,2]
    C0001688
    UMLS CUI [15,1]
    C0018939
    UMLS CUI [15,2]
    C0683336
    estimated disease-free survival of less than one year
    Description

    Disease-Free Survival Estimated

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0242793
    UMLS CUI [1,2]
    C0750572
    ecog performance status of 0, 1, 2
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    lack of 6/6 or 5/6 hla matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
    Description

    Living related donor HLA Matched Quantity Lack | Unrelated Donors HLA Matched Quantity Lack | Donor Unavailable | Hemopoietic stem cell transplant Curative

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3494891
    UMLS CUI [1,2]
    C1548978
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [1,4]
    C0332268
    UMLS CUI [2,1]
    C3179133
    UMLS CUI [2,2]
    C1548978
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [2,4]
    C0332268
    UMLS CUI [3,1]
    C0013018
    UMLS CUI [3,2]
    C0686905
    UMLS CUI [4,1]
    C0472699
    UMLS CUI [4,2]
    C1276305
    4/6 or greater hla a, b, crb1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) nc/kg
    Description

    Cord blood specimen HLA-A Antigens Quantity | Cord blood specimen HLA-B Antigens Quantity | Cord blood specimen CRB1 protein Quantity

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0457279
    UMLS CUI [1,2]
    C0019728
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C0457279
    UMLS CUI [2,2]
    C0019737
    UMLS CUI [2,3]
    C1265611
    UMLS CUI [3,1]
    C0457279
    UMLS CUI [3,2]
    C1120837
    UMLS CUI [3,3]
    C1265611
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    cardiac disease: symptomatic congestive hearth failure or rvg or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
    Description

    Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Echocardiography | Left ventricular ejection fraction | Angina Pectoris | Uncontrolled hypertension

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0018799
    UMLS CUI [2]
    C0742758
    UMLS CUI [3]
    C0034610
    UMLS CUI [4]
    C0013516
    UMLS CUI [5]
    C0428772
    UMLS CUI [6]
    C0002962
    UMLS CUI [7]
    C1868885
    pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
    Description

    Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | DLCO Corrected

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0024115
    UMLS CUI [2]
    C0730607
    UMLS CUI [3,1]
    C0085581
    UMLS CUI [3,2]
    C0231220
    UMLS CUI [4,1]
    C1516251
    UMLS CUI [4,2]
    C0205202
    renal disease: serum creatinine > 2.0 mg/dl
    Description

    Kidney Diseases | Creatinine measurement, serum

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0022658
    UMLS CUI [2]
    C0201976
    hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of gilbert's syndrome), sgpt or sgot > 3 x normal
    Description

    Liver diseases | Serum total bilirubin measurement | Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023895
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0017551
    UMLS CUI [4]
    C0201836
    UMLS CUI [5]
    C0201899
    neurologic disease: symptomatic leukoencephalopathy, active dns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
    Description

    nervous system disorder | Leukoencephalopathy Symptomatic | Malignant Neoplasms | Neuropsychiatric syndrome Excludes Transplantation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0027765
    UMLS CUI [2,1]
    C0270612
    UMLS CUI [2,2]
    C0231220
    UMLS CUI [3]
    C0006826
    UMLS CUI [4,1]
    C3203509
    UMLS CUI [4,2]
    C0332196
    UMLS CUI [4,3]
    C0040732
    hiv antibody or hepatitis b surface antigen positivity
    Description

    HIV Seropositivity | Hepatitis B surface antigen positive

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019699
    UMLS CUI [2]
    C0149709
    uncontrolled infection
    Description

    Communicable Disease Uncontrolled

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    pregnancy or breast-feeding mother
    Description

    Pregnancy | Breast Feeding

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147

    Similar models

    Eligibility Lymphoma NCT00299767

    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00299767
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Disease | Non-Hodgkin Lymphoma Chemotherapy refractory | Hodgkin Disease Chemotherapy refractory | Multiple Myeloma Chemotherapy refractory | Non-Hodgkin Lymphoma Recurrent disease | Hodgkin Disease Recurrent disease | Multiple Myeloma Recurrent disease | Chronic Lymphocytic Leukemia | Rai Staging System | Lymphocyte Doubling Time | Chronic Lymphocytic Leukemia Chemotherapy Quantity Resistant | Acute myeloid leukemia in remission | Acute lymphoid leukemia in remission | Cytogenetic Analysis adverse effects | Hematological Disease antecedent
    Item
    disease status: nhl, hd, or mm refractory to chemotherapy or relapsed; cll rai stage iii/iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to 2 chemotherapy regimens; aml or all in second or subsequent remission or in first remission with adverse cytogenetics or antecedent hematologic disorder
    boolean
    C0012634 (UMLS CUI [1])
    C0024305 (UMLS CUI [2,1])
    C0392920 (UMLS CUI [2,2])
    C0205269 (UMLS CUI [2,3])
    C0019829 (UMLS CUI [3,1])
    C0392920 (UMLS CUI [3,2])
    C0205269 (UMLS CUI [3,3])
    C0026764 (UMLS CUI [4,1])
    C0392920 (UMLS CUI [4,2])
    C0205269 (UMLS CUI [4,3])
    C0024305 (UMLS CUI [5,1])
    C0277556 (UMLS CUI [5,2])
    C0019829 (UMLS CUI [6,1])
    C0277556 (UMLS CUI [6,2])
    C0026764 (UMLS CUI [7,1])
    C0277556 (UMLS CUI [7,2])
    C0023434 (UMLS CUI [8])
    C1514715 (UMLS CUI [9])
    C0024264 (UMLS CUI [10,1])
    C2986483 (UMLS CUI [10,2])
    C0023434 (UMLS CUI [11,1])
    C0392920 (UMLS CUI [11,2])
    C1265611 (UMLS CUI [11,3])
    C0332325 (UMLS CUI [11,4])
    C0153886 (UMLS CUI [12])
    C0153876 (UMLS CUI [13])
    C0752095 (UMLS CUI [14,1])
    C0001688 (UMLS CUI [14,2])
    C0018939 (UMLS CUI [15,1])
    C0683336 (UMLS CUI [15,2])
    Disease-Free Survival Estimated
    Item
    estimated disease-free survival of less than one year
    boolean
    C0242793 (UMLS CUI [1,1])
    C0750572 (UMLS CUI [1,2])
    ECOG performance status
    Item
    ecog performance status of 0, 1, 2
    boolean
    C1520224 (UMLS CUI [1])
    Living related donor HLA Matched Quantity Lack | Unrelated Donors HLA Matched Quantity Lack | Donor Unavailable | Hemopoietic stem cell transplant Curative
    Item
    lack of 6/6 or 5/6 hla matched related or 6/6 matched unrelated donor, or a donor is not available within the time frame necessary to perform a potentially curative stem cell transplant
    boolean
    C3494891 (UMLS CUI [1,1])
    C1548978 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0332268 (UMLS CUI [1,4])
    C3179133 (UMLS CUI [2,1])
    C1548978 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C0332268 (UMLS CUI [2,4])
    C0013018 (UMLS CUI [3,1])
    C0686905 (UMLS CUI [3,2])
    C0472699 (UMLS CUI [4,1])
    C1276305 (UMLS CUI [4,2])
    Cord blood specimen HLA-A Antigens Quantity | Cord blood specimen HLA-B Antigens Quantity | Cord blood specimen CRB1 protein Quantity
    Item
    4/6 or greater hla a, b, crb1 cord blood units with a combined nucleated cell dose from of > 3.7 x 10(7) nc/kg
    boolean
    C0457279 (UMLS CUI [1,1])
    C0019728 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0457279 (UMLS CUI [2,1])
    C0019737 (UMLS CUI [2,2])
    C1265611 (UMLS CUI [2,3])
    C0457279 (UMLS CUI [3,1])
    C1120837 (UMLS CUI [3,2])
    C1265611 (UMLS CUI [3,3])
    Item Group
    C0680251 (UMLS CUI)
    Heart Diseases | Symptomatic congestive heart failure | Radionuclide Ventriculography | Echocardiography | Left ventricular ejection fraction | Angina Pectoris | Uncontrolled hypertension
    Item
    cardiac disease: symptomatic congestive hearth failure or rvg or echocardiogram determined left ventricular ejection fraction of < 45%, active angina pectoris, or uncontrolled hypertension
    boolean
    C0018799 (UMLS CUI [1])
    C0742758 (UMLS CUI [2])
    C0034610 (UMLS CUI [3])
    C0013516 (UMLS CUI [4])
    C0428772 (UMLS CUI [5])
    C0002962 (UMLS CUI [6])
    C1868885 (UMLS CUI [7])
    Lung diseases | Severe chronic obstructive pulmonary disease | Restrictive lung disease Symptomatic | DLCO Corrected
    Item
    pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
    boolean
    C0024115 (UMLS CUI [1])
    C0730607 (UMLS CUI [2])
    C0085581 (UMLS CUI [3,1])
    C0231220 (UMLS CUI [3,2])
    C1516251 (UMLS CUI [4,1])
    C0205202 (UMLS CUI [4,2])
    Kidney Diseases | Creatinine measurement, serum
    Item
    renal disease: serum creatinine > 2.0 mg/dl
    boolean
    C0022658 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    Liver diseases | Serum total bilirubin measurement | Gilbert Disease | Alanine aminotransferase measurement | Aspartate aminotransferase measurement
    Item
    hepatic disease: serum bilirubin > 2.0 mg/dl (except in the case of gilbert's syndrome), sgpt or sgot > 3 x normal
    boolean
    C0023895 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0017551 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    C0201899 (UMLS CUI [5])
    nervous system disorder | Leukoencephalopathy Symptomatic | Malignant Neoplasms | Neuropsychiatric syndrome Excludes Transplantation
    Item
    neurologic disease: symptomatic leukoencephalopathy, active dns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
    boolean
    C0027765 (UMLS CUI [1])
    C0270612 (UMLS CUI [2,1])
    C0231220 (UMLS CUI [2,2])
    C0006826 (UMLS CUI [3])
    C3203509 (UMLS CUI [4,1])
    C0332196 (UMLS CUI [4,2])
    C0040732 (UMLS CUI [4,3])
    HIV Seropositivity | Hepatitis B surface antigen positive
    Item
    hiv antibody or hepatitis b surface antigen positivity
    boolean
    C0019699 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    Communicable Disease Uncontrolled
    Item
    uncontrolled infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    Pregnancy | Breast Feeding
    Item
    pregnancy or breast-feeding mother
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])

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