ID
27667
Beschreibung
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
Stichworte
Versionen (1)
- 26.11.17 26.11.17 -
Rechteinhaber
PD Dr. Utz Krug
Hochgeladen am
26. November 2017
DOI
Für eine Beantragung loggen Sie sich ein.
Lizenz
Creative Commons BY-NC 3.0
Modell Kommentare :
Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.
Itemgroup Kommentare für :
Item Kommentare für :
Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.
Sixth cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344
Sixth cycle of therapy
- StudyEvent: ODM
Beschreibung
Medication: AraC
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C0010711
Beschreibung
AraC Protocol
Alias
- UMLS CUI-1
- C0010711
- UMLS CUI-2
- C1507394
Beschreibung
Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C0750480
Beschreibung
Start date AraC
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C0010711
Beschreibung
End Date AraC
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C0010711
Beschreibung
daily dose s.c.
Datentyp
integer
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0021499
Beschreibung
Medikation: BIBF 1120
Alias
- UMLS CUI-1
- C0013227
- UMLS CUI-2
- C2930789
Beschreibung
BIBF 1120 following protocol
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2930789
- UMLS CUI [1,2]
- C1507394
Beschreibung
End date BIBF 1120
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2930789
Beschreibung
Dosis level BIBF 1120
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2930789
- UMLS CUI [1,2]
- C3174092
Beschreibung
BIBF 1120 protocol
Alias
- UMLS CUI-1
- C2930789
- UMLS CUI-2
- C1507394
Beschreibung
Number
Datentyp
integer
Alias
- UMLS CUI [1]
- C0750480
Beschreibung
Start date BIBF 1120
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0808070
- UMLS CUI [1,2]
- C2930789
Beschreibung
End date BIBF 1120
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0806020
- UMLS CUI [1,2]
- C2930789
Beschreibung
Dosis level BIBF 1120
Datentyp
text
Alias
- UMLS CUI [1,1]
- C2930789
- UMLS CUI [1,2]
- C3174092
Beschreibung
daily dose BIBF 1120
Datentyp
text
Maßeinheiten
- mg
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C2930789
Beschreibung
falls wegen AE abgesetzt: AE und ggf. SAE dokumentieren
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2930789
- UMLS CUI [1,2]
- C1444662
- UMLS CUI [1,3]
- C0877248
Beschreibung
Hämatologie
Alias
- UMLS CUI-1
- C0018941
Beschreibung
Week number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
Beschreibung
Date of laboratory evaluation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschreibung
Hemoglobin unit of measurement
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0019046
- UMLS CUI [1,2]
- C1519795
Beschreibung
Hemoglobin Value
Datentyp
float
Alias
- UMLS CUI [1]
- C0019046
Beschreibung
Thrombocytes unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0032181
- UMLS CUI [1,2]
- C1519795
Beschreibung
Thrombocytes value
Datentyp
float
Alias
- UMLS CUI [1]
- C0005821
Beschreibung
Leukocytes unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Beschreibung
Leukocytes value
Datentyp
float
Alias
- UMLS CUI [1]
- C1271681
Beschreibung
Differentialblutbild
Alias
- UMLS CUI-1
- C0162401
Beschreibung
Week number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
Beschreibung
Date of laboratory evaluation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschreibung
Neutrophiles
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200633
Beschreibung
Blasts
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C0005767
Beschreibung
Monocytes normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0205307
Beschreibung
Monocytes %
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0026473
Beschreibung
Eosinophiles normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0750879
- UMLS CUI [1,2]
- C0205307
Beschreibung
Eosinophiles %
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0750879
Beschreibung
Basophiles normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C0205307
Beschreibung
Basophiles %
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200641
Beschreibung
Lymphocytes normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0205307
Beschreibung
Lymphocytes %
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200635
Beschreibung
Promyelocytes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0455279
Beschreibung
Promyelocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0455279
Beschreibung
Myelocytes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0455284
Beschreibung
Myelocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0455284
Beschreibung
Metamyelocytes
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0229635
Beschreibung
Metamyelocytes
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0229635
Beschreibung
Other cells in differential blood count
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Beschreibung
Other cells in differential blood cell count
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Beschreibung
Klinische Chemie
Alias
- UMLS CUI-1
- C0008000
- UMLS CUI-2
- C0022885
Beschreibung
Week number
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0439230
- UMLS CUI [1,2]
- C0449788
Beschreibung
Date of laboratory evaluation
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschreibung
Bilirubin unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1278039
- UMLS CUI [1,2]
- C1519795
Beschreibung
Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0858307
Beschreibung
Bilirubin <= 2xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Beschreibung
Bilirubin >2xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201913
- UMLS CUI [1,2]
- C1519815
Beschreibung
total bilirubin
Datentyp
float
Alias
- UMLS CUI [1]
- C0201913
Beschreibung
GOT unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519795
Beschreibung
Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0036743
- UMLS CUI [1,2]
- C0201899
Beschreibung
GOT <= 3xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Beschreibung
GOT >3xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201899
- UMLS CUI [1,2]
- C1519815
Beschreibung
GOT
Datentyp
float
Alias
- UMLS CUI [1]
- C0201899
Beschreibung
GPT/ALT unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0001899
- UMLS CUI [1,2]
- C1519795
Beschreibung
Bei Patienten mit normalen Bilirubin, GOT und GPT-Werten bei Ersterhebung: Falls Bilirubin > 2 x ULN und GOT und/oder GPT > 3 x ULN bitte als AE of special interest dokumentieren und un- verzüglich auf SAE-Bogen melden.
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C0205307
Beschreibung
GPT/ALT <=3xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Beschreibung
GPT/ALT >3xULN
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201836
- UMLS CUI [1,2]
- C1519815
Beschreibung
GPT/ALT
Datentyp
float
Alias
- UMLS CUI [1]
- C0201836
Beschreibung
AP unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C1519795
Beschreibung
AP normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201850
- UMLS CUI [1,2]
- C0205307
Beschreibung
AP
Datentyp
float
Alias
- UMLS CUI [1]
- C0428332
Beschreibung
LDH unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0202113
- UMLS CUI [1,2]
- C1519795
Beschreibung
LDH normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0853788
Beschreibung
LDH
Datentyp
float
Alias
- UMLS CUI [1]
- C0202113
Beschreibung
Natrium normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0523891
- UMLS CUI [1,2]
- C0205307
Beschreibung
Natrium
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0523891
Beschreibung
Potassium normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0580477
Beschreibung
Potassium
Datentyp
float
Maßeinheiten
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beschreibung
Total Protein unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C1519795
Beschreibung
Total protein normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0555903
- UMLS CUI [1,2]
- C0205307
Beschreibung
Total protein
Datentyp
float
Alias
- UMLS CUI [1]
- C0036836
Beschreibung
Uric acid unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0041980
- UMLS CUI [1,2]
- C1519795
Beschreibung
Uric acid normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0041980
- UMLS CUI [1,2]
- C0205307
Beschreibung
Uric acid
Datentyp
float
Alias
- UMLS CUI [1]
- C0041980
Beschreibung
Urea unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C1519795
Beschreibung
Urea normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0523961
- UMLS CUI [1,2]
- C0205307
Beschreibung
Urea
Datentyp
float
Alias
- UMLS CUI [1]
- C0523961
Beschreibung
Creatinine unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0201976
- UMLS CUI [1,2]
- C1519795
Beschreibung
Creatinine normal
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0860945
Beschreibung
Creatinine
Datentyp
float
Alias
- UMLS CUI [1]
- C0201976
Beschreibung
CRP unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C1519795
Beschreibung
CRP normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0201657
- UMLS CUI [1,2]
- C0205307
Beschreibung
C-reactive protein
Datentyp
float
Alias
- UMLS CUI [1]
- C0006560
Beschreibung
INR normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0525032
- UMLS CUI [1,2]
- C0205307
Beschreibung
INR
Datentyp
integer
Alias
- UMLS CUI [1]
- C0525032
Beschreibung
PTT normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0030605
- UMLS CUI [1,2]
- C0205307
Beschreibung
PTT
Datentyp
integer
Maßeinheiten
- sek
Alias
- UMLS CUI [1]
- C0030605
Beschreibung
Fibrinogen unit
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0016006
- UMLS CUI [1,2]
- C1519795
Beschreibung
Fibrinogen normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0016006
- UMLS CUI [1,2]
- C0205307
Beschreibung
Fibrinogen
Datentyp
float
Alias
- UMLS CUI [1]
- C0016006
Beschreibung
AT III normal
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0200416
- UMLS CUI [1,2]
- C0205307
Beschreibung
AT III
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C0200416
Beschreibung
Knochenmarksuntersuchung Tag 26 +/- 2
Alias
- UMLS CUI-1
- C0005957
Beschreibung
Date of Bone marrow examination
Datentyp
date
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0011008
Beschreibung
sample shipping to
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0005953
- UMLS CUI [1,3]
- C1524049
Beschreibung
Blasts in bone marrow
Datentyp
integer
Alias
- UMLS CUI [1]
- C1982687
Beschreibung
Blasts in bone marrow >5%
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C1982687
Beschreibung
Parameter examined from
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0184921
- UMLS CUI [1,3]
- C0332307
Beschreibung
Extramedullary AML manifestation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
Beschreibung
localisation of extra medullary AML manifestation
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
- UMLS CUI [1,3]
- C0475264
Beschreibung
other location
Datentyp
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0205394
Beschreibung
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
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0023467
Beschreibung
Therapy decision
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348568
- UMLS CUI [1,2]
- C0679006
Beschreibung
Unterschrift
Alias
- UMLS CUI-1
- C2346576
Ähnliche Modelle
Sixth cycle of therapy
- StudyEvent: ODM
C1507394 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
C0021499 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0005767 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0086574 (UMLS CUI [1,2])
C0086574 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
C0450429 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0449438 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])