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ID

29846

Beschrijving

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs Study ID: 104864-201 Clinical Study ID: 104864/A201 Study Title: A Phase III, Open-Label, Multicenter, Randomized, Comparative Study of Topotecan, Ara-C and G-CSF (TAG) versus Idarubicin, Ara-C and G-CSF (IDAG) in MDS Patients with RAEB (High-Risk), RAEB-t or in Patients with AML from a Preceding Phase of MDS Patient Level Data: Clinicaltrials.gov Identifier: Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: topotecan Trade Name: hycamtin Study Indication: Myelodysplastic Syndrome

Link

https://www.gsk-clinicalstudyregister.com/study/104864/201?search=study&#rs

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Versies (1)
  1. 24-04-18 24-04-18 - Halim Ugurlu
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    GSK Study ID 104864-201 Inclusion-Exclusion Criteria and Telephone Randomisation

    Engels

    Inclusion-Exclusion Criteria and Telephone Randomisation

    1 Formulieren  
    Identification Numbers
    Beschrijving

    Identification Numbers

    Alias
    UMLS CUI-1
    C1300638
    Patient Number
    Beschrijving

    Patient Number

    Datatype

    text

    Alias
    UMLS CUI [1]
    C1830427
    Patient Initials
    Beschrijving

    Patient Initials

    Datatype

    text

    Alias
    UMLS CUI [1]
    C2986440
    Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked
    Beschrijving

    Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked

    Alias
    UMLS CUI-1
    C1512693
    Written informed consent (see Sample Informed Consent Form protocol Appendix E)
    Beschrijving

    Written informed consent

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    At least 18 years of age
    Beschrijving

    Age

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    Diagnosis
    Beschrijving

    a)Diagnosis of myelodysplastic syndrome, subcategories of refractory anemia with excess of blasts, INT 2 or high risk (RAEB) as defined by Greenberg, et al, [4] (see protocol Appendix L), or refractory anemia with excess of blasts in transformation (RAEB-t) OR b)Diagnosis of AML which has evolved from a preceding phase of MDS defined as the presence of antecedent hematologic disorder existing for at least the past three months, AML and/or poor prognosis cytogenetics.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0011900
    UMLS CUI [1,2]
    C0023467
    UMLS CUI [2,1]
    C0011900
    UMLS CUI [2,2]
    C3463824
    Performance Status and life expectancy
    Beschrijving

    Performance status <= 2 (Zubrod-ECOG-WHO cale, protocol Appendix C) and life expectancy =>6 weeks.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1520224
    UMLS CUI [1,2]
    C0023671
    Prior Chemotherapy
    Beschrijving

    Patients must not have received prior chemotherapy except low-dose ara-C, hydroxyurea, or intrathecal methotrexate for MDS or AML.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0332300
    UMLS CUI [1,3]
    C0010711
    UMLS CUI [1,4]
    C1707814
    UMLS CUI [1,5]
    C0025677
    UMLS CUI [1,6]
    C0677897
    Recovery from all toxicities
    Beschrijving

    Recovery from all toxicities since last chemotherapy and/or biologic therapy, unless specific conditions discussed with medical monitor.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013221
    UMLS CUI [1,2]
    C2004454
    Previous malignancies
    Beschrijving

    Patients with previous malignancies in CR for one year or greater.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C2735088
    UMLS CUI [1,2]
    C0006826
    Not being candidate for curative allogenic bone marrow transplant
    Beschrijving

    Patients must not be candidates for curative allogenic bone marrow transplant at the time of treatment, although it is recognized they may become candidates at a future time (i.e., a matched donor is found).

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0030705
    UMLS CUI [1,2]
    C1548788
    UMLS CUI [1,3]
    C0149615
    Limited Laboratory Values
    Beschrijving

    Current laboratory values within the limits listed below unless agreed upon by the principal investigator and the medical monitor: - creatinine <= 1.5 mg/dL (133 micromol/l) - serum bilirubin <= 2.0 mg/dL (34 micromol/l) SGOT/SGPT <= 2 times the upper limit of normal

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0022877
    UMLS CUI [1,2]
    C0042295
    Left ventricular ejection fraction
    Beschrijving

    Patients must have a left ventricular ejection fraction (LVEF) of at least 50%

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0428772
    Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked
    Beschrijving

    Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked

    Alias
    UMLS CUI-1
    C0680251
    Eligibilty for curative allogenic bone marrow transplant
    Beschrijving

    Patients who are eligible for curative allogenic bone marrow transplant without additional treatment.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0149615
    UMLS CUI [1,2]
    C0013893
    Patients with chromosomal abnormalities
    Beschrijving

    Patients with chromosomal abnormalities of t(15;17), t(8;21), or inv(16)

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0008625
    UMLS CUI [1,2]
    C2348235
    Patients with CMML
    Beschrijving

    Patients with CMML.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0023480
    Less than 3 weeks since major surgery
    Beschrijving

    Less than 3 weeks since major surgery, except for placement of central line.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0679637
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C0040223
    Concomitant malignancies
    Beschrijving

    Concomitant malignancies with the exception of curatively treated basal cell carcinoma of the skin, carcinoma in situ of the cervix and previous malignancies in CR for less than one year.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0006826
    UMLS CUI [1,2]
    C0332196
    UMLS CUI [1,3]
    C0007114
    UMLS CUI [1,4]
    C2216722
    UMLS CUI [1,5]
    C0242793
    Concurrent severe medical problems unrelated to the malignancy
    Beschrijving

    Concurrent severe medical problems unrelated to the malignancy which would significantly limit the full compliance with the study or expose the patient to extreme risk.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205082
    Uncontrolled or severe cardiovascular disease
    Beschrijving

    Uncontrolled or severe cardiovascular disease including recent (< 3 months) myocardial infarction or congestive heart failure.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0007222
    UMLS CUI [1,2]
    C0205318
    UMLS CUI [1,3]
    C0205082
    Active infection
    Beschrijving

    Active infection

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3714514
    UMLS CUI [1,2]
    C0205177
    History of (+) HIV
    Beschrijving

    Patients who have a history of (+) HIV.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0019693
    UMLS CUI [1,2]
    C0262926
    Patients who have (+) PPD with abnormal CXR
    Beschrijving

    Patients who have (+) PPD with abnormal CXR

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0032739
    UMLS CUI [1,2]
    C2041426
    UMLS CUI [1,3]
    C0205161
    Females of child-bearing potential, not practicing adequate contraception
    Beschrijving

    Females of child-bearing potential, not practicing adequate contraception. Females of child-bearing potential, premenopausal (less than 60 years of age), or not surgically sterilized must use effective contraception by barrier method contraception, an interuterine device (IUD) or use of birth control pill for 3 months prior to entry into the study and agree to continue to use it during the study and for at least 4 weeks after the end of study drug administration.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C1960468
    UMLS CUI [1,2]
    C0700589
    Pregnancy or lactation.
    Beschrijving

    Pregnancy or lactation.

    Datatype

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    UMLS CUI [2]
    C0006147
    Use of an investigational drug
    Beschrijving

    Use of an investigational drug (including a cytotoxic drug) within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0013230
    UMLS CUI [1,2]
    C0040223
    Concurrent use of other chemotherapy
    Beschrijving

    Concurrent use of other chemotherapy

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0003392
    UMLS CUI [1,2]
    C4060806
    Any chemotherapy with topotecan or idarubicin
    Beschrijving

    Any chemotherapy with topotecan or idarubicin

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C3665472
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [2]
    C0020789
    History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.
    Beschrijving

    History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0020517
    UMLS CUI [1,2]
    C0146224
    UMLS CUI [1,3]
    C0733521
    UMLS CUI [1,4]
    C0020789
    UMLS CUI [1,5]
    C0079459
    Patient known to be refractory to "platelet transfusions."
    Beschrijving

    Patient known to be refractory to "platelet transfusions."

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0086818
    UMLS CUI [1,2]
    C0205269
    Telephone Randomisation
    Beschrijving

    Telephone Randomisation

    Alias
    UMLS CUI-1
    C0039457
    UMLS CUI-2
    C0034656
    Has a randomized number been obtained for the patient using the centralized telephone number?
    Beschrijving

    Telephone Randomisation

    Datatype

    boolean

    Alias
    UMLS CUI [1,1]
    C0039457
    UMLS CUI [1,2]
    C0034656
    If Yes to Telephone Randomisation
    Beschrijving

    If Yes to Telephone Randomisation

    Alias
    UMLS CUI-1
    C0039457
    UMLS CUI-2
    C0034656
    Randomization Number
    Beschrijving

    Please record the patient's randomization number

    Datatype

    text

    Alias
    UMLS CUI [1,1]
    C1300638
    UMLS CUI [1,2]
    C0034656
    Regimen
    Beschrijving

    Please indicate which regimen the patient is scheduled to receive below

    Datatype

    text

    Alias
    UMLS CUI [1]
    C0392920
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    Similar models

    Inclusion-Exclusion Criteria and Telephone Randomisation

    1 Formulieren
    Name
    Type
    Description | Question | Decode (Coded Value)
    Datatype
    Alias
    Item Group
    Identification Numbers
    C1300638 (UMLS CUI-1)
    Patient Number
    Item
    Patient Number
    text
    C1830427 (UMLS CUI [1])
    Patient Initials
    Item
    Patient Initials
    text
    C2986440 (UMLS CUI [1])
    Item Group
    Inclusion Criteria-Do not admit the patient to this study if any "No" box has been marked
    C1512693 (UMLS CUI-1)
    Written informed consent
    Item
    Written informed consent (see Sample Informed Consent Form protocol Appendix E)
    boolean
    C0021430 (UMLS CUI [1])
    Age
    Item
    At least 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Diagnosis
    Item
    Diagnosis
    boolean
    C0011900 (UMLS CUI [1,1])
    C0023467 (UMLS CUI [1,2])
    C0011900 (UMLS CUI [2,1])
    C3463824 (UMLS CUI [2,2])
    Performance Status and life expectancy
    Item
    Performance Status and life expectancy
    boolean
    C1520224 (UMLS CUI [1,1])
    C0023671 (UMLS CUI [1,2])
    Prior Chemotherapy
    Item
    Prior Chemotherapy
    boolean
    C1514457 (UMLS CUI [1,1])
    C0332300 (UMLS CUI [1,2])
    C0010711 (UMLS CUI [1,3])
    C1707814 (UMLS CUI [1,4])
    C0025677 (UMLS CUI [1,5])
    C0677897 (UMLS CUI [1,6])
    Recovery from all toxicities
    Item
    Recovery from all toxicities
    boolean
    C0013221 (UMLS CUI [1,1])
    C2004454 (UMLS CUI [1,2])
    Previous malignancies
    Item
    Previous malignancies
    boolean
    C2735088 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    Not being candidate for curative allogenic bone marrow transplant
    Item
    Not being candidate for curative allogenic bone marrow transplant
    boolean
    C0030705 (UMLS CUI [1,1])
    C1548788 (UMLS CUI [1,2])
    C0149615 (UMLS CUI [1,3])
    Limited Laboratory Values
    Item
    Limited Laboratory Values
    boolean
    C0022877 (UMLS CUI [1,1])
    C0042295 (UMLS CUI [1,2])
    Left ventricular ejection fraction
    Item
    Left ventricular ejection fraction
    boolean
    C0428772 (UMLS CUI [1])
    Item Group
    Exclusion Criteria-Do not admit the patient to this study if any "Yes" box has been marked
    C0680251 (UMLS CUI-1)
    Eligibilty for curative allogenic bone marrow transplant
    Item
    Eligibilty for curative allogenic bone marrow transplant
    boolean
    C0149615 (UMLS CUI [1,1])
    C0013893 (UMLS CUI [1,2])
    Patients with chromosomal abnormalities
    Item
    Patients with chromosomal abnormalities
    boolean
    C0008625 (UMLS CUI [1,1])
    C2348235 (UMLS CUI [1,2])
    Patients with CMML
    Item
    Patients with CMML
    boolean
    C0023480 (UMLS CUI [1])
    Major surgery
    Item
    Less than 3 weeks since major surgery
    boolean
    C0679637 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C0040223 (UMLS CUI [1,3])
    Concomitant malignancies
    Item
    Concomitant malignancies
    boolean
    C0006826 (UMLS CUI [1,1])
    C0332196 (UMLS CUI [1,2])
    C0007114 (UMLS CUI [1,3])
    C2216722 (UMLS CUI [1,4])
    C0242793 (UMLS CUI [1,5])
    Concurrent severe medical problems unrelated to the malignancy
    Item
    Concurrent severe medical problems unrelated to the malignancy
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205082 (UMLS CUI [1,2])
    Uncontrolled or severe cardiovascular disease
    Item
    Uncontrolled or severe cardiovascular disease
    boolean
    C0007222 (UMLS CUI [1,1])
    C0205318 (UMLS CUI [1,2])
    C0205082 (UMLS CUI [1,3])
    Active infection
    Item
    Active infection
    boolean
    C3714514 (UMLS CUI [1,1])
    C0205177 (UMLS CUI [1,2])
    History of (+) HIV
    Item
    History of (+) HIV
    boolean
    C0019693 (UMLS CUI [1,1])
    C0262926 (UMLS CUI [1,2])
    Patients who have (+) PPD with abnormal CXR
    Item
    Patients who have (+) PPD with abnormal CXR
    boolean
    C0032739 (UMLS CUI [1,1])
    C2041426 (UMLS CUI [1,2])
    C0205161 (UMLS CUI [1,3])
    Females of child-bearing potential, not practicing adequate contraception
    Item
    Females of child-bearing potential, not practicing adequate contraception
    boolean
    C1960468 (UMLS CUI [1,1])
    C0700589 (UMLS CUI [1,2])
    Pregnancy or lactation.
    Item
    Pregnancy or lactation.
    boolean
    C0032961 (UMLS CUI [1])
    C0006147 (UMLS CUI [2])
    Use of an investigational drug
    Item
    Use of an investigational drug
    boolean
    C0013230 (UMLS CUI [1,1])
    C0040223 (UMLS CUI [1,2])
    Concurrent use of other chemotherapy
    Item
    Concurrent use of other chemotherapy
    boolean
    C0003392 (UMLS CUI [1,1])
    C4060806 (UMLS CUI [1,2])
    Any chemotherapy with topotecan or idarubicin
    Item
    Any chemotherapy with topotecan or idarubicin
    boolean
    C3665472 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C0020789 (UMLS CUI [2])
    History of hypersensitivity
    Item
    History of hypersensitivity to compounds chemically related to topotecan, ara-C, idarubicin or G-CSF.
    boolean
    C0020517 (UMLS CUI [1,1])
    C0146224 (UMLS CUI [1,2])
    C0733521 (UMLS CUI [1,3])
    C0020789 (UMLS CUI [1,4])
    C0079459 (UMLS CUI [1,5])
    Patient known to be refractory to "platelet transfusions."
    Item
    Patient known to be refractory to "platelet transfusions."
    boolean
    C0086818 (UMLS CUI [1,1])
    C0205269 (UMLS CUI [1,2])
    Item Group
    Telephone Randomisation
    C0039457 (UMLS CUI-1)
    C0034656 (UMLS CUI-2)
    Telephone Randomisation
    Item
    Has a randomized number been obtained for the patient using the centralized telephone number?
    boolean
    C0039457 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    Item Group
    If Yes to Telephone Randomisation
    C0039457 (UMLS CUI-1)
    C0034656 (UMLS CUI-2)
    Randomization Number
    Item
    Randomization Number
    text
    C1300638 (UMLS CUI [1,1])
    C0034656 (UMLS CUI [1,2])
    Item
    Regimen
    text
    C0392920 (UMLS CUI [1])
    Regimen
    Code List
    Regimen
    CL Item
    Topotecan, ara-C G-CSF (TA)
    CL Item
    Idarubicin, ara-C G-CSF (AA)
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