ID

27675

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 )

Regular end of Study

1 forms  
  1. StudyEvent: ODM
    1. Regular end of Study
Reguläres Studienende (28 Tage nach letzter BIBF 1120- oder AraC-Gabe)
Description

Reguläres Studienende (28 Tage nach letzter BIBF 1120- oder AraC-Gabe)

Alias
UMLS CUI-1
C0444496
UMLS CUI-2
C0205272
Reguläres Studienende am:
Description

Date of regular end of study

Data type

date

Alias
UMLS CUI [1,1]
C0444496
UMLS CUI [1,2]
C0011008
Klinischer Befund
Description

Klinischer Befund

Alias
UMLS CUI-1
C0031809
Untersuchungsdatum
Description

Date of physical examination

Data type

date

Alias
UMLS CUI [1]
C2826643
ECOG Status
Description

ECOG Status

Data type

integer

Alias
UMLS CUI [1]
C1520224
Gewicht
Description

Weight

Data type

float

Measurement units
  • Kg
Alias
UMLS CUI [1]
C0005910
Kg
Klinisch relevante körperliche Untersuchungsbefunde
Description

physical examination

Data type

integer

Alias
UMLS CUI [1]
C0031809
Auffällig, bitte spezifizieren
Description

Specify physical examination

Data type

text

Alias
UMLS CUI [1]
C0747585
Hämatologie
Description

Hämatologie

Alias
UMLS CUI-1
C0018941
Datum
Description

Date of laboratory evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Hämoglobin
Description

Hemoglobin unit of measurement

Data type

integer

Alias
UMLS CUI [1,1]
C0019046
UMLS CUI [1,2]
C1519795
Laborwert
Description

Hemoglobin Value

Data type

float

Alias
UMLS CUI [1]
C0019046
Thrombozyten
Description

Thrombocytes unit

Data type

integer

Alias
UMLS CUI [1,1]
C0032181
UMLS CUI [1,2]
C1519795
Laborwert
Description

Thrombocytes value

Data type

float

Alias
UMLS CUI [1]
C0005821
Leukozyten
Description

Leukocytes unit

Data type

integer

Alias
UMLS CUI [1,1]
C0023508
UMLS CUI [1,2]
C1519795
Laborwert
Description

Leukocytes value

Data type

float

Alias
UMLS CUI [1]
C1271681
Differentialblutbild
Description

Differentialblutbild

Alias
UMLS CUI-1
C0162401
Datum
Description

Date of laboratory evaluation

Data type

date

Alias
UMLS CUI [1,1]
C0022885
UMLS CUI [1,2]
C0011008
Neutrophile
Description

Neutrophiles

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200633
%
Blasten
Description

Blasts

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0587348
UMLS CUI [1,2]
C0005767
%
Monozyten normal
Description

Monocytes normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0026473
UMLS CUI [1,2]
C0205307
Monozyten
Description

Monocytes %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0026473
%
Eosinophile normal
Description

Eosinophiles normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0750879
UMLS CUI [1,2]
C0205307
Eosinophile
Description

Eosinophiles %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0750879
%
Basophile normal
Description

Basophiles normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0200641
UMLS CUI [1,2]
C0205307
Basophile
Description

Basophiles %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200641
%
Lymphozyten normal
Description

Lymphocytes normal

Data type

boolean

Alias
UMLS CUI [1,1]
C0200635
UMLS CUI [1,2]
C0205307
Lymphozyten
Description

Lymphocytes %

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0200635
%
keine Promyelozyten
Description

Promyelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0455279
Promyelozyten
Description

Promyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455279
%
keine Myelozyten
Description

Myelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0455284
Myelozyten
Description

Myelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0455284
%
keine Metamyelozyten
Description

Metamyelocytes

Data type

boolean

Alias
UMLS CUI [1]
C0229635
Metamyelozyten
Description

Metamyelocytes

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1]
C0229635
%
keine sonstigen Zellen
Description

Other cells in differential blood count

Data type

boolean

Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0086574
Sonstige Zellen
Description

Other cells in differential blood cell count

Data type

float

Measurement units
  • %
Alias
UMLS CUI [1,1]
C0162401
UMLS CUI [1,2]
C0086574
%
Knochenmarksuntersuchung Tag 26 +/- 2
Description

Knochenmarksuntersuchung Tag 26 +/- 2

Alias
UMLS CUI-1
C0005957
Datum
Description

Date of Bone marrow examination

Data type

date

Alias
UMLS CUI [1,1]
C0005957
UMLS CUI [1,2]
C0011008
nicht durchgeführt
Description

Bone marrow examination not done

Data type

boolean

Alias
UMLS CUI [1]
C0005957
Versand von Knochenmark und Blut für das wissenschaftliche Begleitprogramm nach
Description

sample shipping to

Data type

integer

Alias
UMLS CUI [1,1]
C0178913
UMLS CUI [1,2]
C0005953
UMLS CUI [1,3]
C1524049
Blastenanteil
Description

Blasts in bone marrow

Data type

integer

Alias
UMLS CUI [1]
C1982687
wenn ≥ 5 %, dann bitte angeben:
Description

Blasts in bone marrow >5%

Data type

integer

Measurement units
  • %
Alias
UMLS CUI [1]
C1982687
%
Extramedulläre AML-Manifestation
Description

Extramedullary AML manifestation

Data type

integer

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0023467
Wenn ja, Lokalisation
Description

localisation of extra medullary AML manifestation

Data type

integer

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0023467
UMLS CUI [1,3]
C0475264
andere Lokalisation
Description

other location

Data type

text

Alias
UMLS CUI [1,1]
C1868812
UMLS CUI [1,2]
C0450429
UMLS CUI [1,3]
C0205394
Remissionsstatus
Description

CR: < 5% KM-Blasten, Neutrophile > 1.000/μl, Thrombozyten > 100.000/μl CRp: < 5% KM-Blasten, Neutrophile > 1.000/μl, Thrombozyten < 100.000/μl CRi: < 5% KM-Blasten, Neutrophile < 1.000/μl, unabhängig von der Thrombozytenzahl

Data type

integer

Alias
UMLS CUI [1,1]
C0544452
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0023467
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
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

Regular end of Study

1 forms
  1. StudyEvent: ODM
    1. Regular end of Study
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Reguläres Studienende (28 Tage nach letzter BIBF 1120- oder AraC-Gabe)
C0444496 (UMLS CUI-1)
C0205272 (UMLS CUI-2)
Date of regular end of study
Item
Reguläres Studienende am:
date
C0444496 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
Klinischer Befund
C0031809 (UMLS CUI-1)
Date of physical examination
Item
Untersuchungsdatum
date
C2826643 (UMLS CUI [1])
Item
ECOG Status
integer
C1520224 (UMLS CUI [1])
ECOG Status
Code List
ECOG Status
CL Item
ECOG Status 0 (Normale Leistungsfähigkeit) (0)
CL Item
ECOG Status 1 (Ambulante Betreuung, leichte Arbeiten möglich) (1)
CL Item
ECOG Status 2 (Weniger als 50% am Tage bettlägerig, Selbstversorgung möglich, aber nicht arbeitsfähig) (2)
CL Item
ECOG Status 3 (Mehr als 50% am Tage bettlägerig, begrenzte Selbstversorgung noch möglich) (3)
CL Item
ECOG Status 4 (Ständig bettlägerig) (4)
Weight
Item
Gewicht
float
C0005910 (UMLS CUI [1])
Item
Klinisch relevante körperliche Untersuchungsbefunde
integer
C0031809 (UMLS CUI [1])
physical examination
Code List
Klinisch relevante körperliche Untersuchungsbefunde
CL Item
unauffällig/keine Änderung zur Vorvisite (1)
(Comment:de-DE)
CL Item
auffällig, bitte spezifzieren (2)
(Comment:de-DE)
Specify physical examination
Item
Auffällig, bitte spezifizieren
text
C0747585 (UMLS CUI [1])
Item Group
Hämatologie
C0018941 (UMLS CUI-1)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Hämoglobin
integer
C0019046 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Hemoglobin unit of measurement
Code List
Hämoglobin
CL Item
mmol/l (1)
CL Item
g/dl (2)
Hemoglobin Value
Item
Laborwert
float
C0019046 (UMLS CUI [1])
Item
Thrombozyten
integer
C0032181 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Thrombocytes unit
Code List
Thrombozyten
CL Item
/μl  (1)
CL Item
10^3/μl (2)
Thrombocytes value
Item
Laborwert
float
C0005821 (UMLS CUI [1])
Item
Leukozyten
integer
C0023508 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
Leukocytes unit
Code List
Leukozyten
CL Item
/μl  (1)
CL Item
10^3/μl (2)
Leukocytes value
Item
Laborwert
float
C1271681 (UMLS CUI [1])
Item Group
Differentialblutbild
C0162401 (UMLS CUI-1)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Neutrophiles
Item
Neutrophile
float
C0200633 (UMLS CUI [1])
Blasts
Item
Blasten
float
C0587348 (UMLS CUI [1,1])
C0005767 (UMLS CUI [1,2])
Monocytes normal
Item
Monozyten normal
boolean
C0026473 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Monocytes %
Item
Monozyten
float
C0026473 (UMLS CUI [1])
Eosinophiles normal
Item
Eosinophile normal
boolean
C0750879 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Eosinophiles %
Item
Eosinophile
float
C0750879 (UMLS CUI [1])
Basophiles normal
Item
Basophile normal
boolean
C0200641 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Basophiles %
Item
Basophile
float
C0200641 (UMLS CUI [1])
Lymphocytes normal
Item
Lymphozyten normal
boolean
C0200635 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
Lymphocytes %
Item
Lymphozyten
float
C0200635 (UMLS CUI [1])
Promyelocytes
Item
keine Promyelozyten
boolean
C0455279 (UMLS CUI [1])
Promyelocytes
Item
Promyelozyten
float
C0455279 (UMLS CUI [1])
Myelocytes
Item
keine Myelozyten
boolean
C0455284 (UMLS CUI [1])
Myelocytes
Item
Myelozyten
float
C0455284 (UMLS CUI [1])
Metamyelocytes
Item
keine Metamyelozyten
boolean
C0229635 (UMLS CUI [1])
Metamyelocytes
Item
Metamyelozyten
float
C0229635 (UMLS CUI [1])
Other cells in differential blood count
Item
keine sonstigen Zellen
boolean
C0162401 (UMLS CUI [1,1])
C0086574 (UMLS CUI [1,2])
Other cells in differential blood cell count
Item
Sonstige Zellen
float
C0162401 (UMLS CUI [1,1])
C0086574 (UMLS CUI [1,2])
Item Group
Knochenmarksuntersuchung Tag 26 +/- 2
C0005957 (UMLS CUI-1)
Date of Bone marrow examination
Item
Datum
date
C0005957 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Bone marrow examination not done
Item
nicht durchgeführt
boolean
C0005957 (UMLS CUI [1])
Item
Versand von Knochenmark und Blut für das wissenschaftliche Begleitprogramm nach
integer
C0178913 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
sample shipping to
Code List
Versand von Knochenmark und Blut für das wissenschaftliche Begleitprogramm nach
CL Item
Münster (1)
CL Item
Dresden (2)
CL Item
Frankfurt/Main (3)
Item
Blastenanteil
integer
C1982687 (UMLS CUI [1])
Blasts in bone marrow
Code List
Blastenanteil
CL Item
<5% (1)
CL Item
>= 5% (2)
CL Item
nicht beurteilbar (3)
CL Item
nicht untersucht (weil z.B. P. sicca) (4)
Blasts in bone marrow >5%
Item
wenn ≥ 5 %, dann bitte angeben:
integer
C1982687 (UMLS CUI [1])
Item
Extramedulläre AML-Manifestation
integer
C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
Extramedullary AML manifestation
Code List
Extramedulläre AML-Manifestation
CL Item
ja  (1)
CL Item
nein (2)
CL Item
nicht bekannt (3)
Item
Wenn ja, Lokalisation
integer
C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
localisation of extra medullary AML manifestation
Code List
Wenn ja, Lokalisation
CL Item
ZNS (1)
CL Item
andere (2)
other location
Item
andere Lokalisation
text
C1868812 (UMLS CUI [1,1])
C0450429 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
Item
Remissionsstatus
integer
C0544452 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
Remission status
Code List
Remissionsstatus
CL Item
CR (1)
CL Item
CRp (2)
CL Item
CRi (3)
CL Item
Rezidiv am: (4)
CL Item
Tod am: (5)
CL Item
nicht beurteilter (6)
CL Item
nicht bekannt (7)
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])
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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