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ID

27678

Beskrivning

Phase I/II Trial: BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia (AML) - NCT01488344 https://clinicaltrials.gov/ct2/show/NCT01488344 Principal Investigator PD Dr. Utz Krug RATIONALE: Low-dose cytarabine works in a minority of elderly patients with an acute myeloid leukemia unfit for intensive induction therapy by killing of leukemia cells. Addition of BIBF1120 to low-dose cytarabine might enhance the killing of leukemia cells. PURPOSE: This phase I / II trial is studying how safe BIBF1120 can be combined with low-dose cytarabine (phase I) and how well the combination of low-dose cytarabine and BIBF1120 works in elderly patients with acute myeloid leukemia unfit for intensive chemotherapy (phase II). Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Single-arm, Open Label, Multi-center Phase I/II Trial to Assess the Safety and Efficacy of BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML Unfit for an Intensive Induction Therapy

Länk

https://clinicaltrials.gov/ct2/show/NCT01488344

Nyckelord

Versioner (1)
  1. 2017-11-26 2017-11-26 -
Rättsinnehavare

PD Dr. Utz Krug

Uppladdad den

26 november 2017

DOI

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Licens

Creative Commons BY-NC 3.0
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    BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344

    Tysk ( localization.languageCode.DE )

    Withdrawal from study

    1 Formulär  
    1. StudyEvent: ODM
      1. Withdrawal from study
    Studienabbruch
    Beskrivning

    Studienabbruch

    Alias
    UMLS CUI-1
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    Vorzeitiger Studienabbruch am
    Beskrivning

    Date of withdrawal from study

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0444496 (End of protocol)
    SNOMED
    255253007
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Primärer Grund
    Beskrivning

    Reason for study withdrawal

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C0392360 (Indication of (contextual qualifier))
    SNOMED
    230165009
    LOINC
    MTHU008319
    AE-Nr.:
    Beskrivning

    Adverse event code

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0877248 (Adverse event)
    LOINC
    MTHU014542
    UMLS CUI [1,2]
    C0805701 (Code)
    UMLS CUI [1,3]
    C1521902 (To specify)
    Rezidiv am:
    Beskrivning

    Date of relapse

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C0035020 (Relapse)
    SNOMED
    263855007
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Art des Rezidivs:
    Beskrivning

    AML Type of relapse

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0205336 (Relapsing course)
    SNOMED
    255318003
    Art des extramedullären Rezidives
    Beskrivning

    Extramedullary relapse

    Datatyp

    integer

    Alias
    UMLS CUI [1,1]
    C0023467 (Leukemia, Myelocytic, Acute)
    SNOMED
    17788007
    UMLS CUI [1,2]
    C0035020 (Relapse)
    SNOMED
    263855007
    UMLS CUI [1,3]
    C1517060 (Extramedullary)
    Andere extramedulläre Rezidivlokalisation
    Beskrivning

    Other extramedullary relapse manifestation

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C1868812 (Leukaemic infiltration extramedullary)
    UMLS CUI [1,2]
    C1521902 (To specify)
    Tod am:
    Beskrivning

    Date of death

    Datatyp

    date

    Alias
    UMLS CUI [1]
    C1148348 (Date of death)
    SNOMED
    399753006
    LOINC
    MTHU014693
    Anderer Grund:
    Beskrivning

    Other reason for withdrawal

    Datatyp

    text

    Alias
    UMLS CUI [1,1]
    C0422727 (Patient withdrawn from trial)
    SNOMED
    185924006
    UMLS CUI [1,2]
    C3840932 (Other Reason)
    LOINC
    LA6535-4
    Unterschrift
    Beskrivning

    Unterschrift

    Alias
    UMLS CUI-1
    C2346576 (Investigator Signature)
    Datum
    Beskrivning

    Date of investigator signature

    Datatyp

    date

    Alias
    UMLS CUI [1,1]
    C2346576 (Investigator Signature)
    UMLS CUI [1,2]
    C0011008 (Date in time)
    SNOMED
    410671006
    Name
    Beskrivning

    Investigator name

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2826892 (Investigator Name)
    Unterschrift
    Beskrivning

    Investigator signature

    Datatyp

    text

    Alias
    UMLS CUI [1]
    C2346576 (Investigator Signature)
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    Similar models

    Withdrawal from study

    1 Formulär
    1. StudyEvent: ODM
      1. Withdrawal from study
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datatyp
    Alias
    Item Group
    Studienabbruch
    C0422727 (UMLS CUI-1)
    Date of withdrawal from study
    Item
    Vorzeitiger Studienabbruch am
    date
    C0444496 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Primärer Grund
    integer
    C0422727 (UMLS CUI [1,1])
    C0392360 (UMLS CUI [1,2])
    Reason for study withdrawal
    Code List
    Primärer Grund
    CL Item
    Unerwünschte(s) Ereignis(se) (1)
    CL Item
    Erkrankungsprogression (2)
    CL Item
    primär refraktär nach 6 Therapiezyklen (3)
    CL Item
    Rezidiv am: (4)
    CL Item
    Tod am: (5)
    CL Item
    Einverständnis entzogen (6)
    CL Item
    Fehlende Compliance (7)
    CL Item
    Anderer Grund (8)
    Adverse event code
    Item
    AE-Nr.:
    text
    C0877248 (UMLS CUI [1,1])
    C0805701 (UMLS CUI [1,2])
    C1521902 (UMLS CUI [1,3])
    Date of relapse
    Item
    Rezidiv am:
    date
    C0035020 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Item
    Art des Rezidivs:
    integer
    C0023467 (UMLS CUI [1,1])
    C0205336 (UMLS CUI [1,2])
    AML Type of relapse
    Code List
    Art des Rezidivs:
    CL Item
    Knochenmark  (1)
    CL Item
    extramedullär (2)
    Item
    Art des extramedullären Rezidives
    integer
    C0023467 (UMLS CUI [1,1])
    C0035020 (UMLS CUI [1,2])
    C1517060 (UMLS CUI [1,3])
    Extramedullary relapse
    Code List
    Art des extramedullären Rezidives
    CL Item
    ZNS (1)
    CL Item
    andere (2)
    Other extramedullary relapse manifestation
    Item
    Andere extramedulläre Rezidivlokalisation
    text
    C1868812 (UMLS CUI [1,1])
    C1521902 (UMLS CUI [1,2])
    Date of death
    Item
    Tod am:
    date
    C1148348 (UMLS CUI [1])
    Other reason for withdrawal
    Item
    Anderer Grund:
    text
    C0422727 (UMLS CUI [1,1])
    C3840932 (UMLS CUI [1,2])
    Item Group
    Unterschrift
    C2346576 (UMLS CUI-1)
    Date of investigator signature
    Item
    Datum
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    Investigator name
    Item
    Name
    text
    C2826892 (UMLS CUI [1])
    Investigator signature
    Item
    Unterschrift
    text
    C2346576 (UMLS CUI [1])
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