0 Bedömningar
ID

13705

Beskrivning

Busulfan, Melphalan, and Fludarabine With Peri-transplant Palifermin, Followed by a T-Cell Depleted Hematopoietic Stem Cell Transplant From HLA Matched or Mismatched Related or Unrelated Donors in Patients With Advanced Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML); ODM derived from: https://clinicaltrials.gov/show/NCT00629798

Länk

https://clinicaltrials.gov/show/NCT00629798

Nyckelord

Versioner (1)
  1. 2016-02-29 2016-02-29 -
Rättsinnehavare

CC BY-NC 3.0

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29 februari 2016

DOI

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Creative Commons BY-NC 3.0
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    Eligibility Acute Myeloid Leukemia NCT00629798

    Engelsk

    Eligibility Acute Myeloid Leukemia NCT00629798

    1 Formulär  
    Inclusion Criteria
    Beskrivning

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.
    Beskrivning

    patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    patients may be of either gender or any ethnic background.
    Beskrivning

    patients may be of either gender or any ethnic background.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0079399
    UMLS CUI [2]
    C0015031
    patients must have a karnofsky or lansky performance status > or equal to 70%.
    Beskrivning

    patients must have a karnofsky or lansky performance status > or equal to 70%.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0206065
    patients must have adequate organ function measured by:
    Beskrivning

    patients must have adequate organ function measured by:

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0678852
    * cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.
    Beskrivning

    * cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
    Beskrivning

    hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1278039
    UMLS CUI [2]
    C0201836
    renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2
    Beskrivning

    renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    UMLS CUI [2]
    C0373595
    pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)
    Beskrivning

    pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1516251
    each patient must be willing to participate as a research subject and must sign an informed consent form.
    Beskrivning

    each patient must be willing to participate as a research subject and must sign an informed consent form.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    parent or legal guardians of patients who are minors will sign the informed consent form.
    Beskrivning

    parent or legal guardians of patients who are minors will sign the informed consent form.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Exclusion Criteria
    Beskrivning

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    active cns or skin leukemic involvement
    Beskrivning

    active cns or skin leukemic involvement

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1332884
    UMLS CUI [2]
    C1304525
    female patients who are pregnant or breast-feeding
    Beskrivning

    female patients who are pregnant or breast-feeding

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    active viral, bacterial or fungal infection
    Beskrivning

    active viral, bacterial or fungal infection

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0009450
    patient seropositive for hiv-i/ii; htlv -i/ii
    Beskrivning

    patient seropositive for hiv-i/ii; htlv -i/ii

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0019682
    UMLS CUI [2]
    C0020094
    patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
    Beskrivning

    patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C1504389
    patients who have had a previous malignancy that is not in remission.
    Beskrivning

    patients who have had a previous malignancy that is not in remission.

    Datatyp

    boolean

    Alias
    UMLS CUI [1]
    C0006826
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    Similar models

    Eligibility Acute Myeloid Leukemia NCT00629798

    1 Formulär
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    age
    Item
    patients should be < 65 years. patients > or equal to 65 years will be accrued on a case by case basis after discussion and approval by the bmt service.
    boolean
    C0001779 (UMLS CUI [1])
    patients may be of either gender or any ethnic background.
    Item
    patients may be of either gender or any ethnic background.
    boolean
    C0079399 (UMLS CUI [1])
    C0015031 (UMLS CUI [2])
    karnofsky or lansky performance status
    Item
    patients must have a karnofsky or lansky performance status > or equal to 70%.
    boolean
    C0206065 (UMLS CUI [1])
    organ function
    Item
    patients must have adequate organ function measured by:
    boolean
    C0678852 (UMLS CUI [1])
    LVEF
    Item
    * cardiac: asymptomatic or if symptomatic then lvef at rest must be > or equal to 50% and must improve with exercise.
    boolean
    C0428772 (UMLS CUI [1])
    alt and bilirubin
    Item
    hepatic: < 3x uln alt and < 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia.
    boolean
    C1278039 (UMLS CUI [1])
    C0201836 (UMLS CUI [2])
    creatinine or crcl
    Item
    renal: serum creatinine < than or equal to 1.2 mg/dl or if serum creatinine is outside the normal range, then crcl > 60-ml/min/1.73 m2
    boolean
    C0201976 (UMLS CUI [1])
    C0373595 (UMLS CUI [2])
    pulmonary function
    Item
    pulmonary: asymptomatic or if symptomatic, dlco > 50% of predicted (corrected for hemoglobin)
    boolean
    C1516251 (UMLS CUI [1])
    informed consent form
    Item
    each patient must be willing to participate as a research subject and must sign an informed consent form.
    boolean
    C0021430 (UMLS CUI [1])
    informed consent form of minors
    Item
    parent or legal guardians of patients who are minors will sign the informed consent form.
    boolean
    C0021430 (UMLS CUI [1])
    Item Group
    C0680251 (UMLS CUI)
    cns leukemia or skin involvement
    Item
    active cns or skin leukemic involvement
    boolean
    C1332884 (UMLS CUI [1])
    C1304525 (UMLS CUI [2])
    pregnancy or breast feeding
    Item
    female patients who are pregnant or breast-feeding
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    active infection
    Item
    active viral, bacterial or fungal infection
    boolean
    C0009450 (UMLS CUI [1])
    HIV or HTLV
    Item
    patient seropositive for hiv-i/ii; htlv -i/ii
    boolean
    C0019682 (UMLS CUI [1])
    C0020094 (UMLS CUI [2])
    stem cell transplant
    Item
    patients who have undergone a prior allogeneic or autologous stem cell transplant within the previous six months.
    boolean
    C1504389 (UMLS CUI [1])
    previous malignancy
    Item
    patients who have had a previous malignancy that is not in remission.
    boolean
    C0006826 (UMLS CUI [1])
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