Informatie:
Fout:
ID
27115
Beschrijving
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
Trefwoorden
Versies (1)
- 01-11-17 01-11-17 -
Houder van rechten
PD Dr. Utz Krug
Geüploaded op
1 november 2017
DOI
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Licentie
Creative Commons BY-NC 3.0
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Second cycle of therapy- BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344
Second cycle of therapy
- StudyEvent: ODM
Similar models
Second cycle of therapy
- StudyEvent: ODM
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Date of physical examination
Item
Untersuchungsdatum
date
C2826643 (UMLS CUI [1])
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])
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
Medication: AraC; Tag 1 (1. Gabe AraC)
C0013227 (UMLS CUI-1)
C0010711 (UMLS CUI-2)
C0010711 (UMLS CUI-2)
AraC following protocol
Item
AraC wurde gemäß Protokoll (2 x 20mg s.c. Tag 1 - 10; ges. 400mg) appliziert.
boolean
C0010711 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,2])
Number
Item
Nr.
integer
C0750480 (UMLS CUI [1])
Start date AraC
Item
Start
date
C0808070 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
End Date AraC
Item
Ende
date
C0806020 (UMLS CUI [1,1])
C0010711 (UMLS CUI [1,2])
C0010711 (UMLS CUI [1,2])
daily dose s.c.
Item
tägliche Gabe s.c.
integer
C2348070 (UMLS CUI [1,1])
C0021499 (UMLS CUI [1,2])
C0021499 (UMLS CUI [1,2])
BIBF 1120 following protocol
Item
BIBF 1120 wurde in diesem Zyklus durchgehend in einer Dosierung appliziert
boolean
C2930789 (UMLS CUI [1,1])
C1507394 (UMLS CUI [1,2])
C1507394 (UMLS CUI [1,2])
End date BIBF 1120
Item
Start: Tag 1(= Tag 1 AraC) und Ende:
date
C0806020 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
CL Item
1 x 100 mg (DL 0)
CL Item
2 x 100 mg (DL 1)
CL Item
2 x 150 mg (DL 2)
CL Item
2 x 200 mg (DL 3)
Number
Item
Nr.
integer
C0750480 (UMLS CUI [1])
Start date BIBF 1120
Item
Start
date
C0808070 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
End date BIBF 1120
Item
Ende
date
C0806020 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
CL Item
1 x 100 mg (DL 0)
CL Item
2 x 100 mg (DL 1)
CL Item
2 x 150 mg (DL 2)
CL Item
2 x 200 mg (DL 3)
daily dose BIBF 1120
Item
Falls abweichend von DL: tägliche Gabe
text
C2348070 (UMLS CUI [1,1])
C2930789 (UMLS CUI [1,2])
C2930789 (UMLS CUI [1,2])
Item
Sofern BIBF 1120 abgesetzt wurde: abgesetzt wegen AE
integer
C2930789 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
C1444662 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,3])
CL Item
ja (1)
CL Item
nein/nk (2)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Hämoglobin
integer
C0019046 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mmol/l (1)
CL Item
g/dl (2)
Hemoglobin Value
Item
Laborwert
float
C0019046 (UMLS CUI [1])
CL Item
/μl (1)
CL Item
10^3/μl (2)
Thrombocytes value
Item
Laborwert
float
C0005821 (UMLS CUI [1])
CL Item
/μl (1)
CL Item
10^3/μl (2)
Leukocytes value
Item
Laborwert
float
C1271681 (UMLS CUI [1])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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])
C0005767 (UMLS CUI [1,2])
Monocytes normal
Item
Monozyten normal
boolean
C0026473 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
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])
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])
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])
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])
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])
C0086574 (UMLS CUI [1,2])
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
Date of laboratory evaluation
Item
Datum
date
C0022885 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Bilirubin (gesamt) - Einheit
integer
C1278039 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mg/dl (1)
CL Item
μmol/l (2)
Bilirubin normal
Item
Bilirubin normal
boolean
C0858307 (UMLS CUI [1])
Bilirubin <= 2xULN
Item
Bilirubin bis 2xULN
boolean
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
Bilirubin >2xULN
Item
Bilirubin >2xULN
boolean
C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
total bilirubin
Item
Bilirubin (gesamt)
float
C0201913 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (2)
GOT normal
Item
GOT/AST normal
boolean
C0036743 (UMLS CUI [1,1])
C0201899 (UMLS CUI [1,2])
C0201899 (UMLS CUI [1,2])
GOT <= 3xULN
Item
GOT bis 3xULN
boolean
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
GOT >3xULN
Item
GOT >3xULN
boolean
C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
GOT
Item
GOT/AST
float
C0201899 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (2)
GPT normal
Item
GPT/ALT normal
boolean
C0201836 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
GPT/ALT <=3xULN
Item
GPT/ALT bis 3xULN
boolean
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
GPT/ALT >3xULN
Item
GPT/ALT >3xULN
boolean
C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])
C1519815 (UMLS CUI [1,2])
GPT/ALT
Item
GPT/ALT
float
C0201836 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (2)
AP normal
Item
AP normal
boolean
C0201850 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
AP
Item
AP
float
C0428332 (UMLS CUI [1])
CL Item
U/l (1)
CL Item
μmol/s*l (2)
LDH normal
Item
LDH normal
boolean
C0853788 (UMLS CUI [1])
LDH
Item
LDH
float
C0202113 (UMLS CUI [1])
Natrium normal
Item
Natrium normal
boolean
C0523891 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
Natrium
Item
Natrium
float
C0523891 (UMLS CUI [1])
Potassium normal
Item
Kalium normal
boolean
C0580477 (UMLS CUI [1])
Potassium
Item
Kalium
float
C0202194 (UMLS CUI [1])
Item
Gesamteiweiß - Einheit
integer
C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
g/l (1)
CL Item
g/dl (2)
Total protein normal
Item
Gesamteiweiß normal
boolean
C0555903 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
Total protein
Item
Gesamteiweiß
float
C0036836 (UMLS CUI [1])
CL Item
mg/dl (1)
CL Item
μmol/l (2)
Uric acid normal
Item
Harnsäure normal
boolean
C0041980 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
Uric acid
Item
Harnsäure
float
C0041980 (UMLS CUI [1])
CL Item
mg/dl (1)
CL Item
mmol/l (2)
Urea normal
Item
Harnstoff normal
boolean
C0523961 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
Urea
Item
Harnstoff
float
C0523961 (UMLS CUI [1])
Item
Kreatinin - Einheit
integer
C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mg/dl (1)
CL Item
μmol/l (2)
Creatinine normal
Item
Kreatinin normal
boolean
C0860945 (UMLS CUI [1])
Creatinine
Item
Kreatinin
float
C0201976 (UMLS CUI [1])
CL Item
mg/l (1)
CL Item
mg/dl (2)
CRP normal
Item
CRP normal
boolean
C0201657 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
C-reactive protein
Item
CRP
float
C0006560 (UMLS CUI [1])
INR normal
Item
INR normal
boolean
C0525032 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
INR
Item
INR
integer
C0525032 (UMLS CUI [1])
PTT normal
Item
PTT normal
boolean
C0030605 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
PTT
Item
PTT
integer
C0030605 (UMLS CUI [1])
Item
Fibrinogen - Einheit
integer
C0016006 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])
C1519795 (UMLS CUI [1,2])
CL Item
mg/dl (1)
CL Item
μmol/l (2)
CL Item
g/l (3)
Fibrinogen normal
Item
Fibrinogen normal
boolean
C0016006 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
Fibrinogen
Item
Fibrinogen
float
C0016006 (UMLS CUI [1])
AT III normal
Item
AT III normal
boolean
C0200416 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])
C0205307 (UMLS CUI [1,2])
AT III
Item
AT III
float
C0200416 (UMLS CUI [1])
Date of Bone marrow examination
Item
Datum
date
C0005957 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
Item
Obligater Materialversand (Knochenmark und Blut) nach:
integer
C0178913 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
C0005953 (UMLS CUI [1,2])
C1524049 (UMLS CUI [1,3])
CL Item
Münster (1)
CL Item
Dresden (2)
CL Item
Frankfurt/Main (3)
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
Parameter bestimmt aus
integer
C0022885 (UMLS CUI [1,1])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
CL Item
Punktion (1)
CL Item
Stanze (2)
Item
Extramedulläre AML-Manifestation
integer
C1868812 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,2])
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])
C0023467 (UMLS CUI [1,2])
C0475264 (UMLS CUI [1,3])
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])
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])
C0449438 (UMLS CUI [1,2])
C0023467 (UMLS CUI [1,3])
CL Item
CR (1)
CL Item
CRp (2)
CL Item
CRi (3)
CL Item
partielle Remission (4)
CL Item
stabile Erkrankung (5)
CL Item
Progression (Abbruchkriterium) (6)
Item
Therapieentscheidung
integer
C2348568 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
CL Item
Ende der Behandlung, da CR, CRp, CRi (Dokumentation des regulären Studienendes 28 Tage nach letzter BIBF 1120- oder AraC-Gabe ab S. 44) (1)
CL Item
Fortsetzung der Behandlung (Dokumentation des nächsten Therapiezyklus) (2)
CL Item
Abbruch wegen Progression, intolerabler Toxizität oder Tod (Dokumentation des Studienabbruchs auf S. 46) (Sofern erforderlich: bitte AE und ggf. SAE dokumentieren) (3)
Date of investigator signature
Item
Datum
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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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