ID
27675
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)
- 26-11-17 26-11-17 -
Houder van rechten
PD Dr. Utz Krug
Geüploaded op
26 november 2017
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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BIBF 1120 Added to Low-dose Cytarabine in Elderly Patients With AML NCT01488344
Regular end of Study
- StudyEvent: ODM
Beschrijving
Klinischer Befund
Alias
- UMLS CUI-1
- C0031809
Beschrijving
Date of physical examination
Datatype
date
Alias
- UMLS CUI [1]
- C2826643
Beschrijving
ECOG Status
Datatype
integer
Alias
- UMLS CUI [1]
- C1520224
Beschrijving
Weight
Datatype
float
Maateenheden
- Kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
physical examination
Datatype
integer
Alias
- UMLS CUI [1]
- C0031809
Beschrijving
Specify physical examination
Datatype
text
Alias
- UMLS CUI [1]
- C0747585
Beschrijving
Hämatologie
Alias
- UMLS CUI-1
- C0018941
Beschrijving
Date of laboratory evaluation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschrijving
Hemoglobin unit of measurement
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0019046
- UMLS CUI [1,2]
- C1519795
Beschrijving
Hemoglobin Value
Datatype
float
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Thrombocytes unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0032181
- UMLS CUI [1,2]
- C1519795
Beschrijving
Thrombocytes value
Datatype
float
Alias
- UMLS CUI [1]
- C0005821
Beschrijving
Leukocytes unit
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Beschrijving
Leukocytes value
Datatype
float
Alias
- UMLS CUI [1]
- C1271681
Beschrijving
Differentialblutbild
Alias
- UMLS CUI-1
- C0162401
Beschrijving
Date of laboratory evaluation
Datatype
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Beschrijving
Neutrophiles
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200633
Beschrijving
Blasts
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C0005767
Beschrijving
Monocytes normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0205307
Beschrijving
Monocytes %
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0026473
Beschrijving
Eosinophiles normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0750879
- UMLS CUI [1,2]
- C0205307
Beschrijving
Eosinophiles %
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0750879
Beschrijving
Basophiles normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C0205307
Beschrijving
Basophiles %
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Lymphocytes normal
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0205307
Beschrijving
Lymphocytes %
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
Promyelocytes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0455279
Beschrijving
Promyelocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455279
Beschrijving
Myelocytes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0455284
Beschrijving
Myelocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455284
Beschrijving
Metamyelocytes
Datatype
boolean
Alias
- UMLS CUI [1]
- C0229635
Beschrijving
Metamyelocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0229635
Beschrijving
Other cells in differential blood count
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Beschrijving
Other cells in differential blood cell count
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Beschrijving
Knochenmarksuntersuchung Tag 26 +/- 2
Alias
- UMLS CUI-1
- C0005957
Beschrijving
Date of Bone marrow examination
Datatype
date
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0011008
Beschrijving
Bone marrow examination not done
Datatype
boolean
Alias
- UMLS CUI [1]
- C0005957
Beschrijving
sample shipping to
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0005953
- UMLS CUI [1,3]
- C1524049
Beschrijving
Blasts in bone marrow
Datatype
integer
Alias
- UMLS CUI [1]
- C1982687
Beschrijving
Blasts in bone marrow >5%
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C1982687
Beschrijving
Extramedullary AML manifestation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
Beschrijving
localisation of extra medullary AML manifestation
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
- UMLS CUI [1,3]
- C0475264
Beschrijving
other location
Datatype
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0205394
Beschrijving
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
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0023467
Beschrijving
Date of relapse
Datatype
date
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0011008
Beschrijving
AML Type of relapse
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C0205336
Beschrijving
Extramedullary relapse
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C0035020
- UMLS CUI [1,3]
- C1517060
Beschrijving
Other extramedullary relapse manifestation
Datatype
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C1521902
Beschrijving
Date of death
Datatype
date
Alias
- UMLS CUI [1]
- C1148348
Beschrijving
Unterschrift
Alias
- UMLS CUI-1
- C2346576
Similar models
Regular end of Study
- StudyEvent: ODM
C0205272 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
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])
C0005953 (UMLS CUI [1,2])
C1524049 (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])
C0011008 (UMLS CUI [1,2])
C0205336 (UMLS CUI [1,2])
C0035020 (UMLS CUI [1,2])
C1517060 (UMLS CUI [1,3])
C1521902 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])