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ID

13165

Description

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

Lien

https://clinicaltrials.gov/show/NCT00475384

Mots-clés

  1. 21/01/2016 21/01/2016 -
Détendeur de droits

CC BY-NC 3.0

Téléchargé le

21 janvier 2016

DOI

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Licence

Creative Commons BY-NC 3.0

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    Eligibility Acute Myelogenous Leukemia NCT00475384

    Eligibility Acute Myelogenous Leukemia NCT00475384

    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    2. cardiac function: left ventricular ejection fraction > 45%
    Description

    cardiac function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    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
    Description

    renal function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    UMLS CUI [3]
    C0017654
    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.
    Description

    hepatic function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0364051
    UMLS CUI [2]
    C1278039
    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.
    Description

    pulmonary function

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0523807
    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;
    Description

    AML

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023467
    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;
    Description

    ALL

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023449
    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
    Description

    MDS

    Type de données

    boolean

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

    family donor

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013018
    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
    Description

    unrelated marrow donor or umbilical cord blood donor

    Type de données

    boolean

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

    healthy family member donor

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0013018
    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.
    Description

    written informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    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.
    Description

    leukapheresis

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023416
    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.
    Description

    pbsc mobilization

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1518999
    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
    Description

    second donation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0472699
    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.
    Description

    medical criteria for blood product donation

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0009450
    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
    Description

    source of peripheral blood mononuclear cells to serve as allosensitizers

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3839712
    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.
    Description

    pregnancy and contraception

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0700589
    19. voluntary written informed consent. children will be asked for assent wherever age appropriate.
    Description

    informed consent

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    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.
    Description

    active infection

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    2. evidence of hiv infection or known hiv positive serology
    Description

    HIV

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    3. presence of active central nervous system (cns) disease
    Description

    CNS disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0007682
    4. all patients who relapse with isolated extramedullary disease after completion of treatment
    Description

    extramedullary disease

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1868812
    5. any prior stem cell transplant
    Description

    stem cell transplant

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1504389

    Similar models

    Eligibility Acute Myelogenous Leukemia NCT00475384

    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    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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