0 Ratings
ID

42590

Description

Plerixafor and Granulocyte Colony-stimulating Factor (G-CSF) With Busulfan, Fludarabine and Thymoglobulin; ODM derived from: https://clinicaltrials.gov/show/NCT00822770

Link

https://clinicaltrials.gov/show/NCT00822770

Keywords

Versions (1)
  1. 9/15/21 9/15/21 -
Copyright Holder

M.D. Anderson Cancer Center Genzyme, a Sanofi Company

Uploaded on

September 15, 2021

DOI

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License

Creative Commons BY-NC 4.0
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    Eligibility Stem Cell Transplantation NCT00822770

    English

    Eligibility Stem Cell Transplantation NCT00822770

    1 forms  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    1. patients age >/=18 to </= 65 years.
    Description

    Age

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    2. diagnosis of aml in first or greater remission, first or subsequent relapse, or primary induction failure; mds with intermediate or high risk international prognostic scoring system (ipss) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; aml arising from mds; or cml which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had >5% blasts in the blood or bone marrow. patients receiving second transplants after relapse are considered in the relapse group.
    Description

    AML in remission | AML in relapse | Primary induction failure in AML | MDS (IPPS score) having failed to respond or recurred after chemotherapy | AML arising from MDS | CML which has failed to respond to imatinib or other tyrosine kinase inhibitor, blasts in the blood or bone marrow

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0023467
    UMLS CUI [1,2]
    C0544452
    UMLS CUI [2,1]
    C0023467
    UMLS CUI [2,2]
    C0277556
    UMLS CUI [3,1]
    C0023467
    UMLS CUI [3,2]
    C2347677
    UMLS CUI [4,1]
    C3463824
    UMLS CUI [4,2]
    C2827405
    UMLS CUI [4,3]
    C0392920
    UMLS CUI [4,4]
    C0231175
    UMLS CUI [5,1]
    C3463824
    UMLS CUI [5,2]
    C2827405
    UMLS CUI [5,3]
    C0392920
    UMLS CUI [5,4]
    C0034897
    UMLS CUI [6,1]
    C0023467
    UMLS CUI [6,2]
    C0678226
    UMLS CUI [6,3]
    C3463824
    UMLS CUI [7,1]
    C0023473
    UMLS CUI [7,2]
    C0935989
    UMLS CUI [7,3]
    C0162643
    UMLS CUI [7,4]
    C0368761
    UMLS CUI [7,5]
    C0005953
    UMLS CUI [7,6]
    C0368761
    UMLS CUI [7,7]
    C0229664
    UMLS CUI [8,1]
    C0023473
    UMLS CUI [8,2]
    C1268567
    UMLS CUI [8,3]
    C0162643
    UMLS CUI [8,4]
    C0368761
    UMLS CUI [8,5]
    C0005953
    UMLS CUI [8,6]
    C0368761
    UMLS CUI [8,7]
    C0229664
    3. white blood count (cbc) </= 20 * 10^9/l.
    Description

    White blood cell count

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0023508
    4. patients should have a histocompatible, related or unrelated volunteer donor available. a histocompatible donor is defined as hla matched related donor or an unrelated donor matched for hla- a, b, c, and dr antigens by high-resolution dna techniques.
    Description

    Histocompatible, related or unrelated volunteer donor available, HLA antigens

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0470187
    UMLS CUI [1,2]
    C4330663
    UMLS CUI [1,3]
    C0019721
    UMLS CUI [2,1]
    C0470187
    UMLS CUI [2,2]
    C4318937
    UMLS CUI [2,3]
    C0019721
    5. zubrod performance status 0 or 1, or karnofsky performance status 90-100%.
    Description

    Zubrod performance status | Karnofsky performance status

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C3714786
    UMLS CUI [2]
    C0206065
    6. left ventricular ejection fraction >/= 45 %. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
    Description

    Left ventricular ejection fraction | Absence of uncontrolled arrythmias | Absence of uncontrolled symptomatic cardiac disease

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    UMLS CUI [2,1]
    C0003811
    UMLS CUI [2,2]
    C0205318
    UMLS CUI [2,3]
    C0332197
    UMLS CUI [3,1]
    C0018799
    UMLS CUI [3,2]
    C0231220
    UMLS CUI [3,3]
    C0205318
    UMLS CUI [3,4]
    C0332197
    7. no symptomatic pulmonary disease. forced expiratory volume in 1 s (fev1), forced vital capacity (fvc) and diffusion capacity of carbon monoxide (dlco) >/= 50 % of expected, corrected for hemoglobin.
    Description

    Absence of symptomatic pulmonary disease | FEV1 | FVC | DLCO

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0024115
    UMLS CUI [1,2]
    C0231220
    UMLS CUI [1,3]
    C0332197
    UMLS CUI [2]
    C0849974
    UMLS CUI [3]
    C3714541
    UMLS CUI [4]
    C1516251
    8. serum creatinine </=1.5 mg/dl.
    Description

    Serum creatinine measurement

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201976
    9. serum glutamic pyruvic transaminase (sgpt) </= 200 iu/ml unless related to the malignancy.
    Description

    Serum glutamic pyruvic transaminase | Serum glutamic pyruvic transaminase related to the malignancy

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201836
    UMLS CUI [2,1]
    C0201836
    UMLS CUI [2,2]
    C0586721
    UMLS CUI [2,3]
    C1705847
    UMLS CUI [2,4]
    C0006826
    UMLS CUI [2,5]
    C0678226
    10. total serum bilirubin </=1.5 mg/dl (unless gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (uln).
    Description

    Total serum bilirubin | Total serum bilirubin due to Gilbert's syndrome | ALP

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0201913
    UMLS CUI [2,1]
    C0201913
    UMLS CUI [2,2]
    C1705847
    UMLS CUI [2,3]
    C0678226
    UMLS CUI [2,4]
    C0017551
    UMLS CUI [3]
    C0201850
    11. patient or patient's legal representative able to sign informed consent.
    Description

    Informed consent signed by patient | Informed consent signed by patient's legal representative

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2,1]
    C0021430
    UMLS CUI [2,2]
    C0030701
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. history of hiv positive.
    Description

    History of HIV seropositivity

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0019699
    UMLS CUI [1,2]
    C0262926
    2. positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
    Description

    HCG test positive in a woman with childbearing potential

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C3831118
    UMLS CUI [1,2]
    C0032976
    UMLS CUI [1,3]
    C0428402
    UMLS CUI [1,4]
    C1446409
    3. pleural/pericardial effusion or ascites estimated >/= 1 liter.
    Description

    Pleural effusion | Pericardial effusion | Ascites

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0032227
    UMLS CUI [2]
    C0031039
    UMLS CUI [3]
    C0003962
    4. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
    Description

    Uncontrolled infection not responding to antimicrobial agents after 7 days of therapy

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C0443071
    UMLS CUI [1,4]
    C0205269
    UMLS CUI [1,5]
    C1948053
    5. history of acute hepatitis, chronic active hepatitis or cirrhosis.
    Description

    History of acute hepatitis | Chronic active hepatitis | Cirrhosis

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0262926
    UMLS CUI [1,2]
    C0267797
    UMLS CUI [2,1]
    C0262926
    UMLS CUI [2,2]
    C0520463
    UMLS CUI [3,1]
    C0262926
    UMLS CUI [3,2]
    C0023890
    6. patients with class 3 or 4 angina (new york heart association (nyha) criteria).
    Description

    Agina pectoris, NYHA classification

    Data type

    boolean

    Alias
    UMLS CUI [1,1]
    C0002962
    UMLS CUI [1,2]
    C1275491
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    Similar models

    Eligibility Stem Cell Transplantation NCT00822770

    1 forms
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Age
    Item
    1. patients age >/=18 to </= 65 years.
    boolean
    C0001779 (UMLS CUI [1])
    AML in remission | AML in relapse | Primary induction failure in AML | MDS (IPPS score) having failed to respond or recurred after chemotherapy | AML arising from MDS | CML which has failed to respond to imatinib or other tyrosine kinase inhibitor, blasts in the blood or bone marrow
    Item
    2. diagnosis of aml in first or greater remission, first or subsequent relapse, or primary induction failure; mds with intermediate or high risk international prognostic scoring system (ipss) score having failed to respond or recurred after chemotherapy; in remission or having active disease after treatment; aml arising from mds; or cml which has failed to respond to imatinib or other tyrosine kinase inhibitor and has had >5% blasts in the blood or bone marrow. patients receiving second transplants after relapse are considered in the relapse group.
    boolean
    C0023467 (UMLS CUI [1,1])
    C0544452 (UMLS CUI [1,2])
    C0023467 (UMLS CUI [2,1])
    C0277556 (UMLS CUI [2,2])
    C0023467 (UMLS CUI [3,1])
    C2347677 (UMLS CUI [3,2])
    C3463824 (UMLS CUI [4,1])
    C2827405 (UMLS CUI [4,2])
    C0392920 (UMLS CUI [4,3])
    C0231175 (UMLS CUI [4,4])
    C3463824 (UMLS CUI [5,1])
    C2827405 (UMLS CUI [5,2])
    C0392920 (UMLS CUI [5,3])
    C0034897 (UMLS CUI [5,4])
    C0023467 (UMLS CUI [6,1])
    C0678226 (UMLS CUI [6,2])
    C3463824 (UMLS CUI [6,3])
    C0023473 (UMLS CUI [7,1])
    C0935989 (UMLS CUI [7,2])
    C0162643 (UMLS CUI [7,3])
    C0368761 (UMLS CUI [7,4])
    C0005953 (UMLS CUI [7,5])
    C0368761 (UMLS CUI [7,6])
    C0229664 (UMLS CUI [7,7])
    C0023473 (UMLS CUI [8,1])
    C1268567 (UMLS CUI [8,2])
    C0162643 (UMLS CUI [8,3])
    C0368761 (UMLS CUI [8,4])
    C0005953 (UMLS CUI [8,5])
    C0368761 (UMLS CUI [8,6])
    C0229664 (UMLS CUI [8,7])
    White blood cell count
    Item
    3. white blood count (cbc) </= 20 * 10^9/l.
    boolean
    C0023508 (UMLS CUI [1])
    Histocompatible, related or unrelated volunteer donor available, HLA antigens
    Item
    4. patients should have a histocompatible, related or unrelated volunteer donor available. a histocompatible donor is defined as hla matched related donor or an unrelated donor matched for hla- a, b, c, and dr antigens by high-resolution dna techniques.
    boolean
    C0470187 (UMLS CUI [1,1])
    C4330663 (UMLS CUI [1,2])
    C0019721 (UMLS CUI [1,3])
    C0470187 (UMLS CUI [2,1])
    C4318937 (UMLS CUI [2,2])
    C0019721 (UMLS CUI [2,3])
    Zubrod performance status | Karnofsky performance status
    Item
    5. zubrod performance status 0 or 1, or karnofsky performance status 90-100%.
    boolean
    C3714786 (UMLS CUI [1])
    C0206065 (UMLS CUI [2])
    Left ventricular ejection fraction | Absence of uncontrolled arrythmias | Absence of uncontrolled symptomatic cardiac disease
    Item
    6. left ventricular ejection fraction >/= 45 %. no uncontrolled arrhythmias or uncontrolled symptomatic cardiac disease.
    boolean
    C0428772 (UMLS CUI [1])
    C0003811 (UMLS CUI [2,1])
    C0205318 (UMLS CUI [2,2])
    C0332197 (UMLS CUI [2,3])
    C0018799 (UMLS CUI [3,1])
    C0231220 (UMLS CUI [3,2])
    C0205318 (UMLS CUI [3,3])
    C0332197 (UMLS CUI [3,4])
    Absence of symptomatic pulmonary disease | FEV1 | FVC | DLCO
    Item
    7. no symptomatic pulmonary disease. forced expiratory volume in 1 s (fev1), forced vital capacity (fvc) and diffusion capacity of carbon monoxide (dlco) >/= 50 % of expected, corrected for hemoglobin.
    boolean
    C0024115 (UMLS CUI [1,1])
    C0231220 (UMLS CUI [1,2])
    C0332197 (UMLS CUI [1,3])
    C0849974 (UMLS CUI [2])
    C3714541 (UMLS CUI [3])
    C1516251 (UMLS CUI [4])
    Serum creatinine measurement
    Item
    8. serum creatinine </=1.5 mg/dl.
    boolean
    C0201976 (UMLS CUI [1])
    Serum glutamic pyruvic transaminase | Serum glutamic pyruvic transaminase related to the malignancy
    Item
    9. serum glutamic pyruvic transaminase (sgpt) </= 200 iu/ml unless related to the malignancy.
    boolean
    C0201836 (UMLS CUI [1])
    C0201836 (UMLS CUI [2,1])
    C0586721 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [2,3])
    C0006826 (UMLS CUI [2,4])
    C0678226 (UMLS CUI [2,5])
    Total serum bilirubin | Total serum bilirubin due to Gilbert's syndrome | ALP
    Item
    10. total serum bilirubin </=1.5 mg/dl (unless gilbert's syndrome) and alkaline phosphatase </=2.5 times laboratory standard upper limit of normal (uln).
    boolean
    C0201913 (UMLS CUI [1])
    C0201913 (UMLS CUI [2,1])
    C1705847 (UMLS CUI [2,2])
    C0678226 (UMLS CUI [2,3])
    C0017551 (UMLS CUI [2,4])
    C0201850 (UMLS CUI [3])
    Informed consent signed by patient | Informed consent signed by patient's legal representative
    Item
    11. patient or patient's legal representative able to sign informed consent.
    boolean
    C0021430 (UMLS CUI [1])
    C0021430 (UMLS CUI [2,1])
    C0030701 (UMLS CUI [2,2])
    Item Group
    C0680251 (UMLS CUI)
    History of HIV seropositivity
    Item
    1. history of hiv positive.
    boolean
    C0019699 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    HCG test positive in a woman with childbearing potential
    Item
    2. positive beta human chorionic gonadotropin (hcg) test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization.
    boolean
    C3831118 (UMLS CUI [1,1])
    C0032976 (UMLS CUI [1,2])
    C0428402 (UMLS CUI [1,3])
    C1446409 (UMLS CUI [1,4])
    Pleural effusion | Pericardial effusion | Ascites
    Item
    3. pleural/pericardial effusion or ascites estimated >/= 1 liter.
    boolean
    C0032227 (UMLS CUI [1])
    C0031039 (UMLS CUI [2])
    C0003962 (UMLS CUI [3])
    Uncontrolled infection not responding to antimicrobial agents after 7 days of therapy
    Item
    4. uncontrolled infection, not responding to appropriate antimicrobial agents after seven days of therapy.
    boolean
    C0009450 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0443071 (UMLS CUI [1,3])
    C0205269 (UMLS CUI [1,4])
    C1948053 (UMLS CUI [1,5])
    History of acute hepatitis | Chronic active hepatitis | Cirrhosis
    Item
    5. history of acute hepatitis, chronic active hepatitis or cirrhosis.
    boolean
    C0262926 (UMLS CUI [1,1])
    C0267797 (UMLS CUI [1,2])
    C0262926 (UMLS CUI [2,1])
    C0520463 (UMLS CUI [2,2])
    C0262926 (UMLS CUI [3,1])
    C0023890 (UMLS CUI [3,2])
    Agina pectoris, NYHA classification
    Item
    6. patients with class 3 or 4 angina (new york heart association (nyha) criteria).
    boolean
    C0002962 (UMLS CUI [1,1])
    C1275491 (UMLS CUI [1,2])
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