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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