ID

27685

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

  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

Adverse events

  1. StudyEvent: ODM
    1. Adverse events
Adverse event
Description

Adverse event

Alias
UMLS CUI-1
C0877248
Number of AE
Description

Number of AE

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0449788
Adverse event (AE)
Description

Adverse event (AE)

Data type

text

Alias
UMLS CUI [1]
C0877248
Adverse event start date
Description

Adverse event start date

Data type

date

Alias
UMLS CUI [1]
C2697888
severity of AE
Description

severity of AE

Data type

integer

Alias
UMLS CUI [1]
C1710066
AE Action taken concerning therapy
Description

AE Action taken concerning therapy

Data type

integer

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C1704758
AE study withdrawal
Description

AE study withdrawal

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0422727
AE connected to study medication
Description

AE connected to study medication

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C2930789
AE connected to AraC
Description

AE connected to AraC

Data type

text

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0010711
CTCAE-Grading
Description

CTCAE-Grading

Data type

integer

Alias
UMLS CUI [1]
C1516728
End of AE
Description

End of AE

Data type

date

Alias
UMLS CUI [1]
C2697886
AE continuous
Description

AE continuous

Data type

boolean

Alias
UMLS CUI [1,1]
C0877248
UMLS CUI [1,2]
C0549178
Adverse event course
Description

Adverse event course

Data type

integer

Alias
UMLS CUI [1]
C1705586
investigator signature
Description

investigator signature

Alias
UMLS CUI-1
C2346576
Date of investigator signature
Description

Date of investigator signature

Data type

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
Investigator name
Description

Investigator name

Data type

text

Alias
UMLS CUI [1]
C2826892
Investigator signature
Description

Investigator signature

Data type

text

Alias
UMLS CUI [1]
C2346576

Similar models

Adverse events

  1. StudyEvent: ODM
    1. Adverse events
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C0877248 (UMLS CUI-1)
Number of AE
Item
integer
C0877248 (UMLS CUI [1,1])
C0449788 (UMLS CUI [1,2])
Adverse event (AE)
Item
text
C0877248 (UMLS CUI [1])
Adverse event start date
Item
date
C2697888 (UMLS CUI [1])
Item
integer
C1710066 (UMLS CUI [1])
Code List
severity of AE
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
integer
C0877248 (UMLS CUI [1,1])
C1704758 (UMLS CUI [1,2])
Code List
AE Action taken concerning therapy
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
Item
text
C1519255 (UMLS CUI [1,1])
C0422727 (UMLS CUI [1,2])
Code List
AE study withdrawal
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
Code List
AE connected to study medication
CL Item
 (j)
CL Item
 (n)
Item
text
C0877248 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
Code List
AE connected to AraC
CL Item
 (j)
CL Item
 (n)
CTCAE-Grading
Item
integer
C1516728 (UMLS CUI [1])
End of AE
Item
date
C2697886 (UMLS CUI [1])
AE continuous
Item
boolean
C0877248 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Item
integer
C1705586 (UMLS CUI [1])
Code List
Adverse event course
CL Item
 (0)
CL Item
 (1)
CL Item
 (2)
CL Item
 (3)
CL Item
 (4)
CL Item
 (5)
Item Group
C2346576 (UMLS CUI-1)
Date of investigator signature
Item
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Investigator name
Item
text
C2826892 (UMLS CUI [1])
Investigator signature
Item
text
C2346576 (UMLS CUI [1])

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