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ID

13165

Beschrijving

Haploidentical Transplantation in Patients With Acute Leukemia and Myelodysplasia; ODM derived from: https://clinicaltrials.gov/show/NCT00475384

Link

https://clinicaltrials.gov/show/NCT00475384

Trefwoorden

  1. 21-01-16 21-01-16 -
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CC BY-NC 3.0

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21 januari 2016

DOI

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Licentie

Creative Commons BY-NC 3.0

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    Eligibility Acute Myelogenous Leukemia NCT00475384

    Eligibility Acute Myelogenous Leukemia NCT00475384

    Inclusion Criteria
    Beschrijving

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693 (Inclusion)
    2. cardiac function: left ventricular ejection fraction > 45%
    Beschrijving

    cardiac function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0428772 (Left ventricular ejection fraction)
    SNOMED
    250908004
    3. renal function: serum creatinine < 2x upper limit of normal for age or if serum creatinine elevated beyond normal, must have creatinine clearance or glomerular filtration rate > 50% lower limit of normal for age
    Beschrijving

    renal function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0201976 (Creatinine measurement, serum (procedure))
    SNOMED
    113075003
    UMLS CUI [2]
    C0373595 (Creatinine clearance measurement)
    SNOMED
    167181009
    UMLS CUI [3]
    C0017654 (Glomerular Filtration Rate)
    SNOMED
    80274001
    4. hepatic function: ast/alt < 3x upper limit of normal for age and bilirubin < 2.0 mg/dl. these criteria do not apply if liver is involved with disease.
    Beschrijving

    hepatic function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0364051 (Aspartate aminotransferase/Alanine aminotransferase:CRto:Pt:Ser/Plas:Qn)
    LOINC
    1916-6
    UMLS CUI [2]
    C1278039 (Serum total bilirubin measurement)
    SNOMED
    313840000
    5. pulmonary function: patient must have room air o2 saturation >95% and no clinical evidence of pulmonary insufficiency unless the lungs are involved with disease.
    Beschrijving

    pulmonary function

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0523807 (Oxygen saturation measurement)
    SNOMED
    104847001
    LOINC
    LP6432-1
    6. patients with acute myelogenous leukemia (aml): induction failure with < 3 induction courses, >/= second or greater complete remission (cr) (defined as <5% blasts in bone marrow and no active extramedullary disease) , cr1 with high risk features defined as history of induction failure, 5q- or monosomy 7 cytogenetic findings;
    Beschrijving

    AML

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    7. patients wih acute lymphocytic leukemia (all): >/= second or greater cr (defined as <5% blasts in bone marrow and no active extramedullary disease), cr1 with high risk features defined as history of induction failure or ph+ or t(4;11) on cytogenetic analysis or any infant with mll rearrangements on cytogenetic analysis;
    Beschrijving

    ALL

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023449 (Acute lymphocytic leukemia)
    SNOMED
    91857003
    LOINC
    LA31346-2
    8. patients with myelodysplastic syndrome (mds): refractory anemia (ra) with excess blasts (eb) with intermediate (int)-1, int-2 or high international prognosis score system (ipss) score, refractory anemia with excess blasts (raeb) in transformation (it) with int-1, int-2 or high ipss score and patients with ra and int-2 ipss score
    Beschrijving

    MDS

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3463824 (MYELODYSPLASTIC SYNDROME)
    SNOMED
    109995007
    9. patients lacking a suitably matched family donor defined by genotypic or phenotypic identity for >/= 5/6 a, b, dr loci
    Beschrijving

    family donor

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013018 (Donor person)
    10. patients lacking an immediately available genotypically matched (6/6) unrelated marrow donor or umbilical cord blood donor with suitable cell dose after a search of greater than or equal to 2 months or patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search
    Beschrijving

    unrelated marrow donor or umbilical cord blood donor

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013018 (Donor person)
    11. patients must have a healthy family member donor who must be at least genotypically hla-a, b, c, dr haploidentical to the patient.
    Beschrijving

    healthy family member donor

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0013018 (Donor person)
    12. donors must sign voluntary, written informed consent or in the case of minor donors such consent must be signed by the parent or guardian and assent will be requested as age appropriate.
    Beschrijving

    written informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    13. donors must be capable of undergoing leukapheresis, have adequate venous access and be willing to undergo placement of a central venous catheter should leukapheresis via peripheral access be inadequate.
    Beschrijving

    leukapheresis

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023416 (Leukapheresis)
    SNOMED
    77257005
    14. note that satisfactory mobilization of donor peripheral blood stem cells (pbsc) to meet protocol criteria must take place prior to initiation of conditioning of the patient.
    Beschrijving

    pbsc mobilization

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1518999 (Peripheral Blood Stem Cells)
    SNOMED
    419583006
    15. donors must be informed that they would be requested to undergo a second donation of pbsc or a bm harvest should the patient fail to demonstrate sustained engraftment after hsct
    Beschrijving

    second donation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0472699 (Hemopoietic stem cell transplant)
    SNOMED
    234336002
    16. donors must meet all the medical criteria for blood product donation, including negative test for hiv, freedom from other active infection, absence of medical condition posing a health risk to donation of pbsc or function of the graft.
    Beschrijving

    medical criteria for blood product donation

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    UMLS CUI [2]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    17. to provide a source of peripheral blood mononuclear cells to serve as allosensitizers patients must either: (a) have a parent disparate with the donor for the haplotype shared by the patient and parent but not shared by the patient and donor; or (b) be able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
    Beschrijving

    source of peripheral blood mononuclear cells to serve as allosensitizers

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C3839712 (Allosensitization)
    SNOMED
    702642003
    18. female patients of child-bearing age must have a negative pregnancy test and be using an form of contraception considered effective and medically acceptable by the investigator.
    Beschrijving

    pregnancy and contraception

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961 (Pregnancy)
    SNOMED
    289908002
    LOINC
    LP75920-6
    UMLS CUI [2]
    C0700589 (Contraceptive methods)
    SNOMED
    13197004
    19. voluntary written informed consent. children will be asked for assent wherever age appropriate.
    Beschrijving

    informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430 (Informed Consent)
    Exclusion Criteria
    Beschrijving

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251 (Exclusion Criteria)
    1. active infection. freedom from active infection is defined as: absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms.
    Beschrijving

    active infection

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0009450 (Communicable Diseases)
    SNOMED
    189822004
    2. evidence of hiv infection or known hiv positive serology
    Beschrijving

    HIV

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0019682 (HIV)
    SNOMED
    19030005
    LOINC
    LP17126-1
    3. presence of active central nervous system (cns) disease
    Beschrijving

    CNS disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0007682 (CNS disorder)
    SNOMED
    23853001
    4. all patients who relapse with isolated extramedullary disease after completion of treatment
    Beschrijving

    extramedullary disease

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1868812 (Leukaemic infiltration extramedullary)
    5. any prior stem cell transplant
    Beschrijving

    stem cell transplant

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C1504389 (Stem cell transplant)

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT00475384

    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    C1512693 (UMLS CUI)
    cardiac function
    Item
    2. cardiac function: left ventricular ejection fraction > 45%
    boolean
    C0428772 (UMLS CUI [1])
    renal function
    Item
    3. renal function: serum creatinine < 2x upper limit of normal for age or if serum creatinine elevated beyond normal, must have creatinine clearance or glomerular filtration rate > 50% lower limit of normal for age
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    C0017654 (UMLS CUI [3])
    hepatic function
    Item
    4. hepatic function: ast/alt < 3x upper limit of normal for age and bilirubin < 2.0 mg/dl. these criteria do not apply if liver is involved with disease.
    boolean
    C0364051 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    pulmonary function
    Item
    5. pulmonary function: patient must have room air o2 saturation >95% and no clinical evidence of pulmonary insufficiency unless the lungs are involved with disease.
    boolean
    C0523807 (UMLS CUI [1])
    AML
    Item
    6. patients with acute myelogenous leukemia (aml): induction failure with < 3 induction courses, >/= second or greater complete remission (cr) (defined as <5% blasts in bone marrow and no active extramedullary disease) , cr1 with high risk features defined as history of induction failure, 5q- or monosomy 7 cytogenetic findings;
    boolean
    C0023467 (UMLS CUI [1])
    ALL
    Item
    7. patients wih acute lymphocytic leukemia (all): >/= second or greater cr (defined as <5% blasts in bone marrow and no active extramedullary disease), cr1 with high risk features defined as history of induction failure or ph+ or t(4;11) on cytogenetic analysis or any infant with mll rearrangements on cytogenetic analysis;
    boolean
    C0023449 (UMLS CUI [1])
    MDS
    Item
    8. patients with myelodysplastic syndrome (mds): refractory anemia (ra) with excess blasts (eb) with intermediate (int)-1, int-2 or high international prognosis score system (ipss) score, refractory anemia with excess blasts (raeb) in transformation (it) with int-1, int-2 or high ipss score and patients with ra and int-2 ipss score
    boolean
    C3463824 (UMLS CUI [1])
    family donor
    Item
    9. patients lacking a suitably matched family donor defined by genotypic or phenotypic identity for >/= 5/6 a, b, dr loci
    boolean
    C0013018 (UMLS CUI [1])
    unrelated marrow donor or umbilical cord blood donor
    Item
    10. patients lacking an immediately available genotypically matched (6/6) unrelated marrow donor or umbilical cord blood donor with suitable cell dose after a search of greater than or equal to 2 months or patients whose medical condition is at high risk of deteriorating or whose disease is at high risk of progression during a donor search
    boolean
    C0013018 (UMLS CUI [1])
    healthy family member donor
    Item
    11. patients must have a healthy family member donor who must be at least genotypically hla-a, b, c, dr haploidentical to the patient.
    boolean
    C0013018 (UMLS CUI [1])
    written informed consent
    Item
    12. donors must sign voluntary, written informed consent or in the case of minor donors such consent must be signed by the parent or guardian and assent will be requested as age appropriate.
    boolean
    C0021430 (UMLS CUI [1])
    leukapheresis
    Item
    13. donors must be capable of undergoing leukapheresis, have adequate venous access and be willing to undergo placement of a central venous catheter should leukapheresis via peripheral access be inadequate.
    boolean
    C0023416 (UMLS CUI [1])
    pbsc mobilization
    Item
    14. note that satisfactory mobilization of donor peripheral blood stem cells (pbsc) to meet protocol criteria must take place prior to initiation of conditioning of the patient.
    boolean
    C1518999 (UMLS CUI [1])
    second donation
    Item
    15. donors must be informed that they would be requested to undergo a second donation of pbsc or a bm harvest should the patient fail to demonstrate sustained engraftment after hsct
    boolean
    C0472699 (UMLS CUI [1])
    medical criteria for blood product donation
    Item
    16. donors must meet all the medical criteria for blood product donation, including negative test for hiv, freedom from other active infection, absence of medical condition posing a health risk to donation of pbsc or function of the graft.
    boolean
    C0019682 (UMLS CUI [1])
    C0009450 (UMLS CUI [2])
    source of peripheral blood mononuclear cells to serve as allosensitizers
    Item
    17. to provide a source of peripheral blood mononuclear cells to serve as allosensitizers patients must either: (a) have a parent disparate with the donor for the haplotype shared by the patient and parent but not shared by the patient and donor; or (b) be able to donate sufficient autologous cells by peripheral blood draw or unstimulated leukapheresis
    boolean
    C3839712 (UMLS CUI [1])
    pregnancy and contraception
    Item
    18. female patients of child-bearing age must have a negative pregnancy test and be using an form of contraception considered effective and medically acceptable by the investigator.
    boolean
    C0032961 (UMLS CUI [1])
    C0700589 (UMLS CUI [2])
    informed consent
    Item
    19. voluntary written informed consent. children will be asked for assent wherever age appropriate.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    active infection
    Item
    1. active infection. freedom from active infection is defined as: absence of an infectious diagnosis or (in patients who have had a recent positive infectious diagnosis) the resolution of fever, documentation of negative cultures or antigen testing, continuation or completion of a course of appropriate therapy, and presence of stable to resolving clinical symptoms.
    boolean
    C0009450 (UMLS CUI [1])
    HIV
    Item
    2. evidence of hiv infection or known hiv positive serology
    boolean
    C0019682 (UMLS CUI [1])
    CNS disease
    Item
    3. presence of active central nervous system (cns) disease
    boolean
    C0007682 (UMLS CUI [1])
    extramedullary disease
    Item
    4. all patients who relapse with isolated extramedullary disease after completion of treatment
    boolean
    C1868812 (UMLS CUI [1])
    stem cell transplant
    Item
    5. any prior stem cell transplant
    boolean
    C1504389 (UMLS CUI [1])

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