ID

27678

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 (1)
  1. 11/26/17 11/26/17 -
Copyright Holder

PD Dr. Utz Krug

Uploaded on

November 26, 2017

DOI

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License

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

German ( localization.languageCode.DE )

Withdrawal from study

1 forms  
  1. StudyEvent: ODM
    1. Withdrawal from study
Studienabbruch
Description

Studienabbruch

Alias
UMLS CUI-1
C0422727
Vorzeitiger Studienabbruch am
Description

Date of withdrawal from study

Data type

date

Alias
UMLS CUI [1,1]
C0444496
UMLS CUI [1,2]
C0011008
Primärer Grund
Description

Reason for study withdrawal

Data type

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0392360
AE-Nr.:
Description

Adverse event code

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C1521902
Rezidiv am:
Description

Date of relapse

Data type

date

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0011008
Art des Rezidivs:
Description

AML Type of relapse

Data type

integer

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0205336
Art des extramedullären Rezidives
Description

Extramedullary relapse

Data type

integer

Alias
UMLS CUI [1,1]
C0023467
UMLS CUI [1,2]
C0035020
UMLS CUI [1,3]
C1517060
Andere extramedulläre Rezidivlokalisation
Description

Other extramedullary relapse manifestation

Data type

text

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C1521902
Tod am:
Description

Date of death

Data type

date

Alias
UMLS CUI [1]
C1148348
Anderer Grund:
Description

Other reason for withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C3840932
Unterschrift
Description

Unterschrift

Alias
UMLS CUI-1
C2346576
Datum
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Unterschrift
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576
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Similar models

Withdrawal from study

1 forms
  1. StudyEvent: ODM
    1. Withdrawal from study
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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