ID

13589

Beschrijving

T-cell Depleted Donor Lymphocyte Infusion (DLI)for Acute Myeloid Leukemia (AML) or High Risk Myelodysplastic Syndrome (MDS); ODM derived from: https://clinicaltrials.gov/show/NCT00242515

Link

https://clinicaltrials.gov/show/NCT00242515

Trefwoorden

  1. 18-02-16 18-02-16 -
Houder van rechten

CC BY-NC 3.0

Geüploaded op

18 februari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Acute Myeloid Leukemia NCT00242515

    Eligibility Acute Myeloid Leukemia NCT00242515

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.
    Beschrijving

    1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    UMLS CUI [2]
    C3463824
    UMLS CUI [3,1]
    C3179010
    UMLS CUI [3,2]
    C0162643
    UMLS CUI [4]
    C0544452
    UMLS CUI [5]
    C0277556
    2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
    Beschrijving

    2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013018
    UMLS CUI [1,2]
    C2348930
    UMLS CUI [2]
    C1518999
    UMLS CUI [3]
    C0596993
    3. both patient and donor must sign written informed consent forms.
    Beschrijving

    3. both patient and donor must sign written informed consent forms.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    ecog ps </= 2;
    Beschrijving

    ecog ps </= 2;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    ejective fraction > 40%;
    Beschrijving

    ejective fraction > 40%;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0232174
    dlco > 40% of predicted;
    Beschrijving

    dlco > 40% of predicted;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1516251
    serum bilirubin </= 1.5x institutional upper limit of normal;
    Beschrijving

    serum bilirubin </= 1.5x institutional upper limit of normal;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;
    Beschrijving

    sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2]
    C0201899
    serum creatinine </= 2x upper limit of normal;
    Beschrijving

    serum creatinine </= 2x upper limit of normal;

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.
    Beschrijving

    creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0373595
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. not fulfilling any of the inclusion criteria
    Beschrijving

    1. not fulfilling any of the inclusion criteria

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1512693
    2. active life-threatening infection
    Beschrijving

    2. active life-threatening infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    3. overt untreated infection
    Beschrijving

    3. overt untreated infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis
    Beschrijving

    4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0019163
    UMLS CUI [3]
    C0019196
    5. pregnant or lactating women
    Beschrijving

    5. pregnant or lactating women

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)
    Beschrijving

    6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013018
    UMLS CUI [1,2]
    C0019682
    UMLS CUI [2,1]
    C0013018
    UMLS CUI [2,2]
    C0019163
    7. unable to donate bone marrow or peripheral blood due to concurrent medical condition
    Beschrijving

    7. unable to donate bone marrow or peripheral blood due to concurrent medical condition

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009488
    UMLS CUI [2]
    C1305211
    UMLS CUI [3]
    C0229664

    Similar models

    Eligibility Acute Myeloid Leukemia NCT00242515

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    aml or high risk mds
    Item
    1. confirmed diagnosis of aml or high risk mds in the following disease stages: induction failure, first or subsequent remission, or untreated first relapse.
    boolean
    C0023467 (UMLS CUI [1])
    C3463824 (UMLS CUI [2])
    C3179010 (UMLS CUI [3,1])
    C0162643 (UMLS CUI [3,2])
    C0544452 (UMLS CUI [4])
    C0277556 (UMLS CUI [5])
    hla-compatible donor
    Item
    2. patient must have an hla-compatible donor willing and capable of donating peripheral blood stem cells preferably or bone marrow progenitor cells using conventional techniques, and lymphocytes if indicated (hla-compatible defined as 5/6 or 6/6 matched related or 6/6 molecular matched unrelated donor)
    boolean
    C0013018 (UMLS CUI [1,1])
    C2348930 (UMLS CUI [1,2])
    C1518999 (UMLS CUI [2])
    C0596993 (UMLS CUI [3])
    written informed consent
    Item
    3. both patient and donor must sign written informed consent forms.
    boolean
    C0021430 (UMLS CUI [1])
    ECOG
    Item
    ecog ps </= 2;
    boolean
    C1520224 (UMLS CUI [1])
    ejection fraction
    Item
    ejective fraction > 40%;
    boolean
    C0232174 (UMLS CUI [1])
    dlco
    Item
    dlco > 40% of predicted;
    boolean
    C1516251 (UMLS CUI [1])
    bilirubin
    Item
    serum bilirubin </= 1.5x institutional upper limit of normal;
    boolean
    C1278039 (UMLS CUI [1])
    ALT and AST
    Item
    sgpt (alt) and sgot (ast) </= 2.5x institutional upper limit of normal;
    boolean
    C0201836 (UMLS CUI [1])
    C0201899 (UMLS CUI [2])
    creatinine
    Item
    serum creatinine </= 2x upper limit of normal;
    boolean
    C0201976 (UMLS CUI [1])
    Creatinine Clearance
    Item
    creatinine clearance >/= 60ml/min. however, renal dysfunction is not an absolute contraindication for nmt as dialysis can be performed during nmt.
    boolean
    C0373595 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    inclusion criteria
    Item
    1. not fulfilling any of the inclusion criteria
    boolean
    C1512693 (UMLS CUI [1])
    life-threatening infection
    Item
    2. active life-threatening infection
    boolean
    C0009488 (UMLS CUI [1])
    overt untreated infection
    Item
    3. overt untreated infection
    boolean
    C0009488 (UMLS CUI [1])
    HIV, hepatitis b or c
    Item
    4. hiv positivity, hepatitis b or c antigen positivity with active hepatitis
    boolean
    C0019682 (UMLS CUI [1])
    C0019163 (UMLS CUI [2])
    C0019196 (UMLS CUI [3])
    pregnancy or lactation
    Item
    5. pregnant or lactating women
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    donor contraindication
    Item
    6. donor contraindication (hiv seropositive confirmed by western blot; hepatitis b antigenemia)
    boolean
    C0013018 (UMLS CUI [1,1])
    C0019682 (UMLS CUI [1,2])
    C0013018 (UMLS CUI [2,1])
    C0019163 (UMLS CUI [2,2])
    unable to donate bone marrow or peripheral blood due to concurrent medical condition
    Item
    7. unable to donate bone marrow or peripheral blood due to concurrent medical condition
    boolean
    C0009488 (UMLS CUI [1])
    C1305211 (UMLS CUI [2])
    C0229664 (UMLS CUI [3])

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