0 Bedömningar

ID

12810

Beskrivning

Safety Study of Gene Modified Donor T-cells Following Partially Mismatched Stem Cell Transplant; ODM derived from: https://clinicaltrials.gov/show/NCT01744223

Länk

https://clinicaltrials.gov/show/NCT01744223

Nyckelord

  1. 2015-12-21 2015-12-21 -
Uppladdad den

21 december 2015

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0

Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Itemgroup-kommentar för :

Item-kommentar för :


    Inga kommentarer

    Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

    Eligibility Acute Lymphoblastic Leukemia NCT01744223

    Eligibility Acute Lymphoblastic Leukemia NCT01744223

    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
    Beskrivning

    lack of suitable stem cell donor or rapidly progressive disease

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0375877 (Stem cell donor (person))
    SNOMED
    430792005
    UMLS CUI [2]
    C0677932 (Progressive Neoplastic Disease)
    hla typing will be performed at high resolution (allele level) for the hla-a, -b, cw, and drbl, and loci. a minimum match of 5/10 is required. the donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: hla-a, hla-b, hla-cw, and hla- drb1.
    Beskrivning

    hla typing

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0242318 (HLA Typing)
    SNOMED
    56633006
    subjects with adequate physical function as measured by:a)cardiac: left ventricular ejection fraction at rest must be >35 percent, or shortening fraction > 25percent. b)hepatic: bilirubin < 2.5 mg/dl; and alt, ast, and alkaline phosphatase < 5 x uln. c)renal: serum creatinine within normal range for age, or creatinine clearance or gfr > 40 ml/min/1.73m2. d)pulmonary: fev 1, fvc, dlco (diffusion capacity) > 50 percent predicted (corrected for hemoglobin); or 02 saturation > 92 percent on room air.
    Beskrivning

    adequate physical function

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0231162 (Normal general body function)
    SNOMED
    81323004
    clinical diagnosis of one of the following: acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
    Beskrivning

    acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0023449 (Acute lymphocytic leukemia)
    SNOMED
    91857003
    LOINC
    LA31346-2
    UMLS CUI [2]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [3]
    C0024299 (Lymphoma)
    SNOMED
    115244002
    LOINC
    LA15685-3
    subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
    Beskrivning

    chemotherapy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0392920 (Chemotherapy Regimen)
    SNOMED
    716872004
    performance status: karnofsky/lansky score > 60 percent.
    Beskrivning

    karnofsky performance

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065 (Karnofsky Performance Status)
    SNOMED
    273546003
    LOINC
    LP267177-6
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    hla-matched, related or 7-or 8/8 allele matched (hla-a,-b,-cw,-drbl) unrelated donor able to donate.
    Beskrivning

    stem cell donor available

    Datatyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0375877 (Stem cell donor (person))
    SNOMED
    430792005
    UMLS CUI [1,2]
    C0470187 (Availability of)
    SNOMED
    103328004
    autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
    Beskrivning

    autologous hematopoietic stem cell transplant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1831743 (Autologous Hematopoietic Stem Cell Transplantation)
    SNOMED
    709115004
    pregnancy or breast-feeding.
    Beskrivning

    pregnant or breastfeeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0549206 (Patient currently pregnant)
    SNOMED
    77386006
    LOINC
    LA14670-6
    UMLS CUI [2]
    C0006147 (Breast Feeding)
    SNOMED
    169741004
    LOINC
    LP420040-0
    evidence of hiv infection or known hiv positive serology.
    Beskrivning

    hiv positivity

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019699 (HIV Seropositivity)
    SNOMED
    165816005
    current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
    Beskrivning

    current uncontrolled bacterial, viral or fungal infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0004623 (Bacterial Infections)
    SNOMED
    87628006
    UMLS CUI [2]
    C0042769 (Virus Diseases)
    SNOMED
    34014006
    UMLS CUI [3]
    C0026946 (Mycoses)
    SNOMED
    3218000
    non-hematologic malignancy within prior three (3) years.
    Beskrivning

    non-hematologic malignancy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0935681 (Non-Hematologic Malignancy)
    prior allogeneic hematopoietic stem cell transplant.
    Beskrivning

    allogeneic hematopoietic stem cell transplant

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C2242529 (Allogeneic Stem Cell Transplantation)
    subjects with a history of primary idiopathic myelofibrosis.
    Beskrivning

    idiopathic myelofibrosis

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001815 (Primary Myelofibrosis)
    SNOMED
    128843003
    bovine product allergy.
    Beskrivning

    bovine product allergy

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0020517 (Hypersensitivity)
    SNOMED
    421961002
    LOINC
    LP20697-6
    UMLS CUI [2]
    C0036774 (serum albumin, bovine)
    SNOMED
    420357009

    Similar models

    Eligibility Acute Lymphoblastic Leukemia NCT01744223

    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    lack of suitable stem cell donor or rapidly progressive disease
    Item
    lack of suitable conventional donor (i.e. 7/8 or 8/8 related or 7/8 or 8/8 unrelated donor) or presence of rapidly progressive disease not permitting time to identify an unrelated donor
    boolean
    C0375877 (UMLS CUI [1])
    C0677932 (UMLS CUI [2])
    hla typing
    Item
    hla typing will be performed at high resolution (allele level) for the hla-a, -b, cw, and drbl, and loci. a minimum match of 5/10 is required. the donor and recipient must be identical, as determined by high resolution typing, at least one allele of each of the following genetic loci: hla-a, hla-b, hla-cw, and hla- drb1.
    boolean
    C0242318 (UMLS CUI [1])
    adequate physical function
    Item
    subjects with adequate physical function as measured by:a)cardiac: left ventricular ejection fraction at rest must be >35 percent, or shortening fraction > 25percent. b)hepatic: bilirubin < 2.5 mg/dl; and alt, ast, and alkaline phosphatase < 5 x uln. c)renal: serum creatinine within normal range for age, or creatinine clearance or gfr > 40 ml/min/1.73m2. d)pulmonary: fev 1, fvc, dlco (diffusion capacity) > 50 percent predicted (corrected for hemoglobin); or 02 saturation > 92 percent on room air.
    boolean
    C0231162 (UMLS CUI [1])
    acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
    Item
    clinical diagnosis of one of the following: acute lymphoblastic leukemia, acute myelogenous leukemia, lymphoma
    boolean
    C0023449 (UMLS CUI [1])
    C0023467 (UMLS CUI [2])
    C0024299 (UMLS CUI [3])
    chemotherapy
    Item
    subjects must have received cytotoxic chemotherapy within 3 months of consent date (measured from the start date of chemotherapy).
    boolean
    C0392920 (UMLS CUI [1])
    karnofsky performance
    Item
    performance status: karnofsky/lansky score > 60 percent.
    boolean
    C0206065 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    stem cell donor available
    Item
    hla-matched, related or 7-or 8/8 allele matched (hla-a,-b,-cw,-drbl) unrelated donor able to donate.
    boolean
    C0375877 (UMLS CUI [1,1])
    C0470187 (UMLS CUI [1,2])
    autologous hematopoietic stem cell transplant
    Item
    autologous hematopoietic stem cell transplant < 3 months prior to enrollment.
    boolean
    C1831743 (UMLS CUI [1])
    pregnant or breastfeeding
    Item
    pregnancy or breast-feeding.
    boolean
    C0549206 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    hiv positivity
    Item
    evidence of hiv infection or known hiv positive serology.
    boolean
    C0019699 (UMLS CUI [1])
    current uncontrolled bacterial, viral or fungal infection
    Item
    current uncontrolled bacterial, viral or fungal infection (currently taking medication with evidence of progression of clinical symptoms or radiologic findings).
    boolean
    C0004623 (UMLS CUI [1])
    C0042769 (UMLS CUI [2])
    C0026946 (UMLS CUI [3])
    non-hematologic malignancy
    Item
    non-hematologic malignancy within prior three (3) years.
    boolean
    C0935681 (UMLS CUI [1])
    allogeneic hematopoietic stem cell transplant
    Item
    prior allogeneic hematopoietic stem cell transplant.
    boolean
    C2242529 (UMLS CUI [1])
    idiopathic myelofibrosis
    Item
    subjects with a history of primary idiopathic myelofibrosis.
    boolean
    C0001815 (UMLS CUI [1])
    bovine product allergy
    Item
    bovine product allergy.
    boolean
    C0020517 (UMLS CUI [1])
    C0036774 (UMLS CUI [2])

    Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

    Watch Tutorial