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ID

42192

Description

Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies; ODM derived from: https://clinicaltrials.gov/show/NCT00113646

Link

https://clinicaltrials.gov/show/NCT00113646

Keywords

Versions (2)
  1. 7/24/16 7/24/16 -
  2. 4/13/21 4/13/21 - Dr. rer. medic Philipp Neuhaus
Uploaded on

April 13, 2021

DOI

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License

Creative Commons BY 4.0
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    Eligibility Lymphoma NCT00113646

    English

    Eligibility Lymphoma NCT00113646

    1 forms  
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00113646
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    disease status: nhl, hd, mm that are chemorefractory or relapsed; cll that is rai stage iii or iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to > 2 cycles of chemotherapy regimens; cml in accelerated or blast phase; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
    Description

    chemorefractory or relapsed nhl, hd, mm / CLL rai stage / accelerated or blast phase CML / MDS with critical cytopenias / patients with previous stem cell transplants / other hematological disorders

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3844738
    UMLS CUI [1,2]
    C0334619
    UMLS CUI [2,1]
    C3844738
    UMLS CUI [2,2]
    C0026764
    UMLS CUI [3,1]
    C0023434
    UMLS CUI [3,2]
    C0023472
    UMLS CUI [4]
    C0005699
    UMLS CUI [5,1]
    C3463824
    UMLS CUI [5,2]
    C1263979
    UMLS CUI [6]
    C1504389
    UMLS CUI [7]
    C0018939
    estimated disease free survival of less than one year
    Description

    life expectancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    ecog performance status of 0, 1, or 2
    Description

    ecog performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    hla 1 to 3 mismatched (at a, b, dr loci) related donor
    Description

    hla mismatched related donor

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0549171
    UMLS CUI [1,2]
    C0029206
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    cardiac disease: symptomatic congestive heart failure, ejection fraction of < 45%, active angina pectoris or uncontrolled hypertension.
    Description

    cardiac disease

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0018802
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [2]
    C0428772
    UMLS CUI [3]
    C0002962
    UMLS CUI [4]
    C1868885
    pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
    Description

    pulmonary disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0024117
    UMLS CUI [2]
    C0085581
    UMLS CUI [3]
    C1516251
    renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min
    Description

    renal disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphate, sgpt or sgot > 3 x normal
    Description

    hepatic disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201850
    UMLS CUI [3]
    C0201836
    UMLS CUI [4]
    C0201899
    neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
    Description

    neurologic disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0270612
    UMLS CUI [2]
    C0348374
    UMLS CUI [3]
    C0233514
    hiv antibody or hepatitis b surface antigen positivity
    Description

    HIV or HBV positivity

    Data type

    boolean

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

    uncontrolled infection

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    presence of hama or haha in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
    Description

    presence of hama or haha

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C1868746
    UMLS CUI [2]
    C1295018
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    Similar models

    Eligibility Lymphoma NCT00113646

    1 forms
    1. StudyEvent: Eligibility
      1. Eligibility Lymphoma NCT00113646
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    chemorefractory or relapsed nhl, hd, mm / CLL rai stage / accelerated or blast phase CML / MDS with critical cytopenias / patients with previous stem cell transplants / other hematological disorders
    Item
    disease status: nhl, hd, mm that are chemorefractory or relapsed; cll that is rai stage iii or iv, or lymphocyte doubling time of 6 months, or stage i/ii resistant to > 2 cycles of chemotherapy regimens; cml in accelerated or blast phase; mds with life-threatening cytopenias; patients who have had a previous autologous or allogeneic bone marrow or stem cell transplant; other hematological disorders where allogeneic transplant is appropriate and the risk of conventional transplantation is considered to be unacceptably high.
    boolean
    C3844738 (UMLS CUI [1,1])
    C0334619 (UMLS CUI [1,2])
    C3844738 (UMLS CUI [2,1])
    C0026764 (UMLS CUI [2,2])
    C0023434 (UMLS CUI [3,1])
    C0023472 (UMLS CUI [3,2])
    C0005699 (UMLS CUI [4])
    C3463824 (UMLS CUI [5,1])
    C1263979 (UMLS CUI [5,2])
    C1504389 (UMLS CUI [6])
    C0018939 (UMLS CUI [7])
    life expectancy
    Item
    estimated disease free survival of less than one year
    boolean
    C0023671 (UMLS CUI [1])
    ecog performance status
    Item
    ecog performance status of 0, 1, or 2
    boolean
    C1520224 (UMLS CUI [1])
    hla mismatched related donor
    Item
    hla 1 to 3 mismatched (at a, b, dr loci) related donor
    boolean
    C0549171 (UMLS CUI [1,1])
    C0029206 (UMLS CUI [1,2])
    Item Group
    C0680251 (UMLS CUI)
    cardiac disease
    Item
    cardiac disease: symptomatic congestive heart failure, ejection fraction of < 45%, active angina pectoris or uncontrolled hypertension.
    boolean
    C0018802 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0428772 (UMLS CUI [2])
    C0002962 (UMLS CUI [3])
    C1868885 (UMLS CUI [4])
    pulmonary disease
    Item
    pulmonary disease: severe chronic obstructive lung disease, or symptomatic restrictive lung disease, or corrected dlco of < 50%
    boolean
    C0024117 (UMLS CUI [1])
    C0085581 (UMLS CUI [2])
    C1516251 (UMLS CUI [3])
    renal disease
    Item
    renal disease: serum creatinine > 2.0 mg/dl or creatinine clearance < 50 ml/min
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    hepatic disease
    Item
    hepatic disease: serum bilirubin > 2.0 mg/dl or alkaline phosphate, sgpt or sgot > 3 x normal
    boolean
    C1278039 (UMLS CUI [1])
    C0201850 (UMLS CUI [2])
    C0201836 (UMLS CUI [3])
    C0201899 (UMLS CUI [4])
    neurologic disease
    Item
    neurologic disease: symptomatic leukoencephalopathy, active cns malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
    boolean
    C0270612 (UMLS CUI [1])
    C0348374 (UMLS CUI [2])
    C0233514 (UMLS CUI [3])
    HIV or HBV positivity
    Item
    hiv antibody or hepatitis b surface antigen positivity
    boolean
    C0019699 (UMLS CUI [1])
    C0149709 (UMLS CUI [2])
    uncontrolled infection
    Item
    uncontrolled infection
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    presence of hama or haha
    Item
    presence of hama or haha in patient previously treated with monoclonal antibody therapy or who have received a product in which the preparation involved a monoclonal antibody affinity step
    boolean
    C1868746 (UMLS CUI [1])
    C1295018 (UMLS CUI [2])
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