ID

26892

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

AML

Medical History Taking

Cytogenetics

10/27/17 10/27/17 -

Copyright Holder

PD Dr. Utz Krug

Uploaded on

October 27, 2017

DOI

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License

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

model
Details

Initial survey

1 forms

StudyEvent: ODM
1. Initial survey

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Medical history

Item Group

Anamnesestatus

C0262926 (UMLS CUI-1)

Medical history AML

Item

Anamnesestatus

integer

C0262926 (UMLS CUI [1,1])
C0023467 (UMLS CUI [1,2])

Medical history AML

Code List

Anamnesestatus

CL Item

De novo AML (außer APL) (1)

CL Item

AML nach MDS/MPS (2)

CL Item

AML nach Chemotherapie (3)

CL Item

AML nach Strahlentherapie (4)

CL Item

therapierefraktäre AML (5)

CL Item

rezidivierte AML (6)

Date of diagnosis MDS/MPS

Item

Diagnosedatum MDS/MPS

date

C2316983 (UMLS CUI [1,1])
C0027022 (UMLS CUI [1,2])
C3463824 (UMLS CUI [2,1])
C2316983 (UMLS CUI [2,2])

Year of first chemotherapy

Item

Jahr der ersten Chemotherapie

partialDate

C1302181 (UMLS CUI [1,1])
C3173309 (UMLS CUI [1,2])

Chemotherapy regime

Item

Schema

text

C0392920 (UMLS CUI [1])

Year of first radiotherapy

Item

Jahr der ersten Strahlentherapie

partialDate

C0436382 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

number of therapy cycles AML

Item

vergangene Therapielinien

integer

C0449788 (UMLS CUI [1,1])
C1302181 (UMLS CUI [1,2])

number of therapy cycles AML

Code List

vergangene Therapielinien

CL Item

1 (1)

CL Item

2 (2)

CL Item

>=3 (3)

Physical examination

Item Group

Klinischer Befund

C0031809 (UMLS CUI-1)

Date of physical examination

Item

Untersuchungsdatum

date

C2826643 (UMLS CUI [1])

ECOG Status

Item

ECOG-Status bei Studieneinschluss

integer

C1520224 (UMLS CUI [1])

ECOG Status

Code List

ECOG-Status bei Studieneinschluss

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])

Height

Item

Größe

integer

C0489786 (UMLS CUI [1])

Heart rate

Item

Puls

integer

C0018810 (UMLS CUI [1])

systolic blood pressure

Item

systolischer Blutdruck

integer

C0871470 (UMLS CUI [1])

diastolic blood pressure

Item

Diastolischer Blutdruck

integer

C0428883 (UMLS CUI [1])

physical examination

Item

Klinisch relevante körperliche Untersuchungsbefunde

integer

C0031809 (UMLS CUI [1])

physical examination

Code List

Klinisch relevante körperliche Untersuchungsbefunde

CL Item

unauffällig (1)

CL Item

auffällig, bitte spezifzieren (2)

Specify physical examination

Item

Auffällig, bitte spezifizieren

text

C0747585 (UMLS CUI [1])

Urinalysis

Item

Urinanalyse

text

C0042014 (UMLS CUI [1])

Urinalysis

Code List

Urinanalyse

CL Item

normal (1)

CL Item

nicht normal (2)

Specify Abnormal urinalysis

Item

Nicht normale Urinanalyse

text

C0438142 (UMLS CUI [1,1])
C1521902 (UMLS CUI [1,2])

Medical history

Item Group

Klinisch relevante Vor-/Begleiterkrankungen

C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)

clinical relevant comorbidities

Item

Klinisch relevante Vor-/Begleiterkrankungen

integer

C0009488 (UMLS CUI [1])

clinical relevant comorbidities

Code List

Klinisch relevante Vor-/Begleiterkrankungen

CL Item

vorhanden (1)

CL Item

nicht vorhanden (2)

Medical history

Item Group

Klinisch relevante Vor-/Begleiterkrankungen

C0262926 (UMLS CUI-1)
C0009488 (UMLS CUI-2)

illness

Item

Erkrankung

text

C0221423 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])

Comorbidity since

Item

Erkrankung seit

partialDate

C0011008 (UMLS CUI [1,1])
C0009488 (UMLS CUI [1,2])
C0332162 (UMLS CUI [1,3])

illness continuous

Item

fortbestehend

boolean

C0009488 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])

Hematology

Item Group

Hämatologie

C0018941 (UMLS CUI-1)

Date of hematology test

Item

Datum

date

C2826641 (UMLS CUI [1,1])
C0474523 (UMLS CUI [1,2])

Hemoglobin unit of measurement

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])

Thrombocytes unit

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])

Leukocytes unit

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])

Differential blood count

Item Group

Differentialblutbild

C0162401 (UMLS CUI-1)

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])

Clinical chemistry

Item Group

Klinische Chemie

C0008000 (UMLS CUI-1)
C0022885 (UMLS CUI-2)

Bilirubin unit

Item

Bilirubin (gesamt) - Einheit

integer

C1278039 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Bilirubin unit

Code List

Bilirubin (gesamt) - Einheit

CL Item

mg/dl (1)

CL Item

μmol/l (2)

Bilirubin normal

Item

Bilirubin normal

boolean

C0858307 (UMLS CUI [1])

Bilirubin > ULN

Item

Bilirubin > ULN

boolean

C0201913 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

total bilirubin

Item

Bilirubin (gesamt)

float

C0201913 (UMLS CUI [1])

GOT unit

Item

GOT/AST - Einheit

integer

C0201899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

GOT unit

Code List

GOT/AST - Einheit

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])

GOT >ULN

Item

GOT >ULN

boolean

C0201899 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

GOT

Item

GOT/AST

float

C0201899 (UMLS CUI [1])

GPT/ALT unit

Item

GPT/ALT - Einheit

integer

C0001899 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

GPT/ALT unit

Code List

GPT/ALT - Einheit

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])

ALT >ULN

Item

GPT/ALT >ULN

boolean

C0201836 (UMLS CUI [1,1])
C1519815 (UMLS CUI [1,2])

GPT/ALT

Item

GPT/ALT

float

C0201836 (UMLS CUI [1])

AP unit

Item

AP - Einheit

integer

C0201850 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

AP unit

Code List

AP - Einheit

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])

Item

float

C0428332 (UMLS CUI [1])

LDH unit

Item

LDH - Einheit

integer

C0202113 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

LDH unit

Code List

LDH - Einheit

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])

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])

Total Protein unit

Item

Gesamteiweiß - Einheit

integer

C0555903 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Total Protein unit

Code List

Gesamteiweiß - Einheit

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])

Total protein

Item

Gesamteiweiß

float

C0036836 (UMLS CUI [1])

Uric acid unit

Item

Harnsäure - Einheit

integer

C0041980 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Uric acid unit

Code List

Harnsäure - Einheit

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])

Uric acid

Item

Harnsäure

float

C0041980 (UMLS CUI [1])

Urea unit

Item

Harnstoff - Einheit

integer

C0523961 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Urea unit

Code List

Harnstoff - Einheit

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])

Urea

Item

Harnstoff

float

C0523961 (UMLS CUI [1])

Creatinine unit

Item

Kreatinin - Einheit

integer

C0201976 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Creatinine unit

Code List

Kreatinin - Einheit

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])

CRP unit

Item

CRP - Einheit

integer

C0201657 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

CRP unit

Code List

CRP - Einheit

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])

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])

INR

Item

INR

integer

C0525032 (UMLS CUI [1])

PTT normal

Item

PTT normal

boolean

C0030605 (UMLS CUI [1,1])
C0205307 (UMLS CUI [1,2])

PTT

Item

PTT

integer

C0030605 (UMLS CUI [1])

Fibrinogen unit

Item

Fibrinogen - Einheit

integer

C0016006 (UMLS CUI [1,1])
C1519795 (UMLS CUI [1,2])

Fibrinogen unit

Code List

Fibrinogen - Einheit

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])

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])

AT III

Item

AT III

float

C0200416 (UMLS CUI [1])

Bone marrow examination

Item Group

Knochenmarksuntersuchung

C0005957 (UMLS CUI-1)

Date of Bone marrow examination

Item

Datum

date

C0005957 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])

Blasts in bone marrow

Item

Blastenanteil

float

C1982687 (UMLS CUI [1])

Blasts in bone marrow not assessable

Item

Blasten nicht beurteilter

boolean

C1982687 (UMLS CUI [1,1])
C1707258 (UMLS CUI [1,2])

Blasts not examined

Item

Blasten nicht untersucht (z.B. P. sicca)

boolean

C1982687 (UMLS CUI [1,1])
C0332129 (UMLS CUI [1,2])

Cellularity

Item

Zellularität

integer

C1561532 (UMLS CUI [1])

Cellularity

Code List

Zellularität

CL Item

0 (0)

CL Item

+1 (1)

CL Item

+2 (2)

CL Item

+3 (3)

Parameter examined from

Item

Parameter bestimmt aus

integer

C0022885 (UMLS CUI [1,1])
C0184921 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])

Parameter examined from

Code List

Parameter bestimmt aus

CL Item

Punktion (1)

CL Item

Stanze (2)

FAB-Classification

Item Group

FAB-Klassifikation

C2984084 (UMLS CUI-1)

FAB type M0

Item

boolean

C0457327 (UMLS CUI [1])

FAB type M1

Item

boolean

C0457328 (UMLS CUI [1])

FAB type M2

Item

boolean

C0457352 (UMLS CUI [1])

FAB type M4

Item

boolean

C0457331 (UMLS CUI [1])

FAB type M4eo

Item

M4eo

boolean

C0457332 (UMLS CUI [1])

FAB type M5

Item

boolean

C0457333 (UMLS CUI [1])

FAB type M5a

Item

M5a

boolean

C0457334 (UMLS CUI [1,1])
C0457333 (UMLS CUI [1,2])

FAB type M5b

Item

M5b

boolean

C0457335 (UMLS CUI [1])

FAB type M6

Item

boolean

C0457336 (UMLS CUI [1])

FAB type M7

Item

boolean

C0457337 (UMLS CUI [1])

FAB type unknown

Item

unbekannt

boolean

C2984084 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])

FAB classification not done

Item

nicht erfolgt

boolean

C2984084 (UMLS CUI [1,1])
C1272696 (UMLS CUI [1,2])

cytogenetics

Item Group

Zytogenetik

C0010802 (UMLS CUI-1)

cytogenetics procedure

Item

Zytogenetik

integer

C0010802 (UMLS CUI [1])

cytogenetics procedure

Code List

Zytogenetik

CL Item

durchgeführt (1)

CL Item

nicht durchgeführt (2)

Karyotype

Item

Karyotyp

integer

C1261273 (UMLS CUI [1])

Karyotype

Code List

Karyotyp

CL Item

normaler Karyotyp (1)

CL Item

t(8;21) (2)

CL Item

t(16;16) (3)

CL Item

-7/7q- (4)

CL Item

t(6;9) (5)

CL Item

+8 als Einzelaberration (6)

CL Item

inv(16) (7)

CL Item

-5/5q- (8)

CL Item

sonstige Aberrationen (9)

CL Item

t(3;3) (10)

CL Item

11q23 - aberrations (11)

CL Item

+8 mit einer weiteren Aberration (außer t(9;11)) (12)

CL Item

komplexer Karyotyp (≥ 3 Läsionen) (13)

other aberration

Item

Sonstige Aberration

text

C0008625 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

molecular genetics

Item Group

Molekulargenetik

C0086345 (UMLS CUI-1)
C0011900 (UMLS CUI-2)

AML1-ETO

Item

AML1-ETO

integer

C0665119 (UMLS CUI [1])

AML1-ETO

Code List

AML1-ETO

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

CBFβ-MYH11

Item

CBFβ-MYH11

integer

C3276534 (UMLS CUI [1])

CBFβ-MYH11

Code List

CBFβ-MYH11

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

C/EBPalpha

Item

C/EBPalpha

integer

C1413322 (UMLS CUI [1])

C/EBPalpha

Code List

C/EBPalpha

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

C/EBPa

Item

C/EBPa: wenn ja:

integer

C1413322 (UMLS CUI [1])

C/EBPa

Code List

C/EBPa: wenn ja:

CL Item

monoallelisch (1)

CL Item

biallelisch (2)

CL Item

unbekannt (3)

NPM1-Mut

Item

NPM1-Mut

integer

C2826175 (UMLS CUI [1])

NPM1-Mut

Code List

NPM1-Mut

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

Flt3 point mutation

Item

Flt3-Punkmutation

integer

C2348501 (UMLS CUI [1])

Flt3 point mutation

Code List

Flt3-Punkmutation

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

Flt3-ITD

Item

Flt3-ITD

integer

C2348499 (UMLS CUI [1])

Flt3-ITD

Code List

Flt3-ITD

CL Item

ja (1)

CL Item

nein (2)

CL Item

nicht untersucht (3)

Flt3-ITD-ratio

Item

Flt3-ITD-ratio

integer

C2348499 (UMLS CUI [1,1])
C0456603 (UMLS CUI [1,2])

Flt3-ITD percentage

Item

Prozentsatz

integer

C2348499 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])

other mutation

Item

Sonstige

text

C0796357 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])

extramedullary AML manifestation

Item Group

Extramedulläre AML-Manifestation

C1868812 (UMLS CUI-1)
C0023467 (UMLS CUI-2)

Extramedullary AML manifestation

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)

localisation of extra medullary AML manifestation

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)

investigator signature

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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Description

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Keywords

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License

Model comments :

Itemgroup comments for :

Item comments for :

Initial survey - BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344

Initial survey

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