ID
26892
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)
- 27.10.17 27.10.17 -
Rechteinhaber
PD Dr. Utz Krug
Hochgeladen am
27. Oktober 2017
DOI
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Lizenz
Creative Commons BY-NC 3.0
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Initial survey - BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344
Initial survey
- StudyEvent: ODM
Beschreibung
Klinischer Befund
Alias
- UMLS CUI-1
- C0031809
Beschreibung
Date of physical examination
Datentyp
date
Alias
- UMLS CUI [1]
- C2826643
Beschreibung
ECOG Status
Datentyp
integer
Alias
- UMLS CUI [1]
- C1520224
Beschreibung
Weight
Datentyp
float
Maßeinheiten
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beschreibung
Height
Datentyp
integer
Maßeinheiten
- cm
Alias
- UMLS CUI [1]
- C0489786
Beschreibung
Heart rate
Datentyp
integer
Alias
- UMLS CUI [1]
- C0018810
Beschreibung
systolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0871470
Beschreibung
diastolic blood pressure
Datentyp
integer
Maßeinheiten
- mmHg
Alias
- UMLS CUI [1]
- C0428883
Beschreibung
physical examination
Datentyp
integer
Alias
- UMLS CUI [1]
- C0031809
Beschreibung
Specify physical examination
Datentyp
text
Alias
- UMLS CUI [1]
- C0747585
Beschreibung
Urinalysis
Datentyp
text
Alias
- UMLS CUI [1]
- C0042014
Beschreibung
Specify Abnormal urinalysis
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0438142
- UMLS CUI [1,2]
- C1521902
Beschreibung
Klinisch relevante Vor-/Begleiterkrankungen
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschreibung
Klinisch relevante Vor-/Begleiterkrankungen
Alias
- UMLS CUI-1
- C0262926
- UMLS CUI-2
- C0009488
Beschreibung
illness
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0221423
- UMLS CUI [1,2]
- C0262926
Beschreibung
Comorbidity since
Datentyp
partialDate
Maßeinheiten
- Monat/Jahr
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0009488
- UMLS CUI [1,3]
- C0332162
Beschreibung
illness continuous
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0009488
- UMLS CUI [1,2]
- C0549178
Beschreibung
Hämatologie
Alias
- UMLS CUI-1
- C0018941
Beschreibung
Date of hematology test
Datentyp
date
Alias
- UMLS CUI [1,1]
- C2826641
- UMLS CUI [1,2]
- C0474523
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
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
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
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 > ULN
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 >ULN
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
ALT >ULN
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
- sec
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
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
Blasts in bone marrow
Datentyp
float
Maßeinheiten
- %
Alias
- UMLS CUI [1]
- C1982687
Beschreibung
Blasts in bone marrow not assessable
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1982687
- UMLS CUI [1,2]
- C1707258
Beschreibung
Blasts not examined
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C1982687
- UMLS CUI [1,2]
- C0332129
Beschreibung
Cellularity
Datentyp
integer
Alias
- UMLS CUI [1]
- C1561532
Beschreibung
Parameter examined from
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0184921
- UMLS CUI [1,3]
- C0332307
Beschreibung
FAB-Klassifikation
Alias
- UMLS CUI-1
- C2984084
Beschreibung
FAB type M0
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457327
Beschreibung
FAB type M1
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457328
Beschreibung
FAB type M2
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457352
Beschreibung
FAB type M4
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457331
Beschreibung
FAB type M4eo
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457332
Beschreibung
FAB type M5
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457333
Beschreibung
FAB type M5a
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C0457334
- UMLS CUI [1,2]
- C0457333
Beschreibung
FAB type M5b
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457335
Beschreibung
FAB type M6
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457336
Beschreibung
FAB type M7
Datentyp
boolean
Alias
- UMLS CUI [1]
- C0457337
Beschreibung
FAB type unknown
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2984084
- UMLS CUI [1,2]
- C0439673
Beschreibung
FAB classification not done
Datentyp
boolean
Alias
- UMLS CUI [1,1]
- C2984084
- UMLS CUI [1,2]
- C1272696
Beschreibung
Zytogenetik
Alias
- UMLS CUI-1
- C0010802
Beschreibung
cytogenetics procedure
Datentyp
integer
Alias
- UMLS CUI [1]
- C0010802
Beschreibung
Karyotype
Datentyp
integer
Alias
- UMLS CUI [1]
- C1261273
Beschreibung
other aberration
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0205394
Beschreibung
Molekulargenetik
Alias
- UMLS CUI-1
- C0086345
- UMLS CUI-2
- C0011900
Beschreibung
AML1-ETO
Datentyp
integer
Alias
- UMLS CUI [1]
- C0665119
Beschreibung
CBFβ-MYH11
Datentyp
integer
Alias
- UMLS CUI [1]
- C3276534
Beschreibung
C/EBPalpha
Datentyp
integer
Alias
- UMLS CUI [1]
- C1413322
Beschreibung
C/EBPa
Datentyp
integer
Alias
- UMLS CUI [1]
- C1413322
Beschreibung
NPM1-Mut
Datentyp
integer
Alias
- UMLS CUI [1]
- C2826175
Beschreibung
Flt3 point mutation
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348501
Beschreibung
Flt3-ITD
Datentyp
integer
Alias
- UMLS CUI [1]
- C2348499
Beschreibung
Flt3-ITD-ratio
Datentyp
integer
Alias
- UMLS CUI [1,1]
- C2348499
- UMLS CUI [1,2]
- C0456603
Beschreibung
Flt3-ITD percentage
Datentyp
integer
Maßeinheiten
- %
Alias
- UMLS CUI [1,1]
- C2348499
- UMLS CUI [1,2]
- C0439165
Beschreibung
other mutation
Datentyp
text
Alias
- UMLS CUI [1,1]
- C0796357
- UMLS CUI [1,2]
- C0205394
Beschreibung
Extramedulläre AML-Manifestation
Alias
- UMLS CUI-1
- C1868812
- UMLS CUI-2
- C0023467
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
Unterschrift
Alias
- UMLS CUI-1
- C2346576
Ähnliche Modelle
Initial survey
- StudyEvent: ODM
C0027022 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C2316983 (UMLS CUI [2,2])
C3173309 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1302181 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0009488 (UMLS CUI-2)
C0009488 (UMLS CUI-2)
C0262926 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,2])
C0474523 (UMLS CUI [1,2])
C1519795 (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])
C1519795 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
C0205307 (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])
C1707258 (UMLS CUI [1,2])
C0332129 (UMLS CUI [1,2])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0457333 (UMLS CUI [1,2])
C0439673 (UMLS CUI [1,2])
C1272696 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0456603 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0023467 (UMLS CUI-2)
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
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