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ID

26670

Description

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

Link

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

Keywords

Versions (2)
  1. 10/17/17 10/17/17 -
  2. 10/23/17 10/23/17 - Julian Varghese
Copyright Holder

PD Dr. Utz Krug

Uploaded on

October 23, 2017

DOI

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License

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

    German ( localization.languageCode.DE )

    Patient registration

    1 forms  
    1. StudyEvent: ODM
      1. Patient registration
    Patientenmeldebogen
    Description

    Patientenmeldebogen

    Alias
    UMLS CUI-1
    C0421512
    Geburtsdatum
    Description

    Date of birth

    Data type

    date

    Alias
    UMLS CUI [1]
    C0421451
    Geschlecht:
    Description

    gender

    Data type

    integer

    Alias
    UMLS CUI [1]
    C0079399
    Der Patient wurde umfassend über die Studie informiert und hat am.... in die Teilnahme schriftlich eingewilligt.
    Description

    Informed consent date

    Data type

    date

    Alias
    UMLS CUI [1]
    C2985782
    Der Patient stimmt der späteren Analyse der von ihm gesammelten Gewebeproben zu.
    Description

    informed consent

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    Patient ist gemäß Ein- und Ausschlusskritieren für die Studie geeignet.
    Description

    Bei nachträglicher Verletzung der Ein- bzw. Ausschlusskriterien bitte Ausschluss auf S. 47 dokumentieren.

    Data type

    boolean

    Alias
    UMLS CUI [1]
    C0013893
    Versand von Knochenmark und Blut für das obligate wissenschaftliche Begleitprogramm nach:
    Description

    bone marrow and blood samples sent to

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1524049
    UMLS CUI [1,2]
    C0420658
    UMLS CUI [1,3]
    C0420652
    Versand der Beckenkammstanz-Biopsie nach:
    Description

    Shipping of an iliac crest biopsy to:

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1524049
    UMLS CUI [1,2]
    C0223651
    UMLS CUI [1,3]
    C0184924
    Datum
    Description

    Date of shipping

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C1524049
    UMLS CUI [1,2]
    C0011008
    Name einsendender Arzt in Druckbuchstaben
    Description

    referring physician's name

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709880
    UMLS CUI [1,2]
    C1547383
    Unterschrift einsendender Arzt
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1,1]
    C1709880
    UMLS CUI [1,2]
    C1519316
    Tel-Nr.
    Description

    Telephone number physician

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1515258
    UMLS CUI [1,2]
    C1709880
    Fax-Nr.
    Description

    Fax referring physician

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C1709880
    UMLS CUI [1,2]
    C1549619
    BIBF 1120 Dosislevel (DL) für Phase I
    Description

    Wird von der Studienzentrale eingetragen und zurück gefaxt.

    Data type

    integer

    Alias
    UMLS CUI [1,1]
    C0304229
    UMLS CUI [1,2]
    C2930789
    UMLS CUI [1,3]
    C0178602
    Pat.-Nr.:
    Description

    Patient number

    Data type

    integer

    Alias
    UMLS CUI [1]
    C1830427
    Unterschrift
    Description

    Investigator signature

    Data type

    text

    Alias
    UMLS CUI [1]
    C2346576
    Name
    Description

    Investigator name

    Data type

    text

    Alias
    UMLS CUI [1]
    C2826892
    Datum
    Description

    Date of investigator signature

    Data type

    date

    Alias
    UMLS CUI [1,1]
    C2346576
    UMLS CUI [1,2]
    C0011008
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    Similar models

    Patient registration

    1 forms
    1. StudyEvent: ODM
      1. Patient registration
    Name
    Type
    Description | Question | Decode (Coded Value)
    Data type
    Alias
    Item Group
    Patientenmeldebogen
    C0421512 (UMLS CUI-1)
    Date of birth
    Item
    Geburtsdatum
    date
    C0421451 (UMLS CUI [1])
    Item
    Geschlecht:
    integer
    C0079399 (UMLS CUI [1])
    gender
    Code List
    Geschlecht:
    CL Item
    weiblich (1)
    CL Item
    männlich (2)
    Informed consent date
    Item
    Der Patient wurde umfassend über die Studie informiert und hat am.... in die Teilnahme schriftlich eingewilligt.
    date
    C2985782 (UMLS CUI [1])
    informed consent
    Item
    Der Patient stimmt der späteren Analyse der von ihm gesammelten Gewebeproben zu.
    boolean
    C0021430 (UMLS CUI [1])
    eligibility determination
    Item
    Patient ist gemäß Ein- und Ausschlusskritieren für die Studie geeignet.
    boolean
    C0013893 (UMLS CUI [1])
    Item
    Versand von Knochenmark und Blut für das obligate wissenschaftliche Begleitprogramm nach:
    integer
    C1524049 (UMLS CUI [1,1])
    C0420658 (UMLS CUI [1,2])
    C0420652 (UMLS CUI [1,3])
    bone marrow and blood samples sent to
    Code List
    Versand von Knochenmark und Blut für das obligate wissenschaftliche Begleitprogramm nach:
    CL Item
    Münster (1)
    CL Item
    Dresden (2)
    CL Item
    Franfurt am Main (3)
    Item
    Versand der Beckenkammstanz-Biopsie nach:
    integer
    C1524049 (UMLS CUI [1,1])
    C0223651 (UMLS CUI [1,2])
    C0184924 (UMLS CUI [1,3])
    Shipping of an iliac crest biopsy to:
    Code List
    Versand der Beckenkammstanz-Biopsie nach:
    CL Item
    Münster (1)
    CL Item
    Dresden (2)
    CL Item
    Franfurt am Main (3)
    Date of shipping
    Item
    Datum
    date
    C1524049 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
    referring physician's name
    Item
    Name einsendender Arzt in Druckbuchstaben
    text
    C1709880 (UMLS CUI [1,1])
    C1547383 (UMLS CUI [1,2])
    Investigator signature
    Item
    Unterschrift einsendender Arzt
    text
    C1709880 (UMLS CUI [1,1])
    C1519316 (UMLS CUI [1,2])
    Telephone number physician
    Item
    Tel-Nr.
    integer
    C1515258 (UMLS CUI [1,1])
    C1709880 (UMLS CUI [1,2])
    Fax referring physician
    Item
    Fax-Nr.
    integer
    C1709880 (UMLS CUI [1,1])
    C1549619 (UMLS CUI [1,2])
    Item
    BIBF 1120 Dosislevel (DL) für Phase I
    integer
    C0304229 (UMLS CUI [1,1])
    C2930789 (UMLS CUI [1,2])
    C0178602 (UMLS CUI [1,3])
    investigational drug dosage
    Code List
    BIBF 1120 Dosislevel (DL) für Phase I
    CL Item
    DL 0: 1 x 100 mg  (1)
    CL Item
    DL 1: 2 x 100 mg  (2)
    CL Item
    DL 2: 2 x 150 mg  (3)
    CL Item
    DL 3: 2 x 200 mg (4)
    Patient number
    Item
    Pat.-Nr.:
    integer
    C1830427 (UMLS CUI [1])
    Investigator signature
    Item
    Unterschrift
    text
    C2346576 (UMLS CUI [1])
    Investigator name
    Item
    Name
    text
    C2826892 (UMLS CUI [1])
    Date of investigator signature
    Item
    Datum
    date
    C2346576 (UMLS CUI [1,1])
    C0011008 (UMLS CUI [1,2])
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