ID
27675
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
Lien
https://clinicaltrials.gov/ct2/show/NCT01488344
Mots-clés
Versions (1)
- 26/11/2017 26/11/2017 -
Détendeur de droits
PD Dr. Utz Krug
Téléchargé le
26 novembre 2017
DOI
Pour une demande vous connecter.
Licence
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
Description
Klinischer Befund
Alias
- UMLS CUI-1
- C0031809
Description
Date of physical examination
Type de données
date
Alias
- UMLS CUI [1]
- C2826643
Description
ECOG Status
Type de données
integer
Alias
- UMLS CUI [1]
- C1520224
Description
Weight
Type de données
float
Unités de mesure
- Kg
Alias
- UMLS CUI [1]
- C0005910
Description
physical examination
Type de données
integer
Alias
- UMLS CUI [1]
- C0031809
Description
Specify physical examination
Type de données
text
Alias
- UMLS CUI [1]
- C0747585
Description
Hämatologie
Alias
- UMLS CUI-1
- C0018941
Description
Date of laboratory evaluation
Type de données
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Description
Hemoglobin unit of measurement
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0019046
- UMLS CUI [1,2]
- C1519795
Description
Hemoglobin Value
Type de données
float
Alias
- UMLS CUI [1]
- C0019046
Description
Thrombocytes unit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0032181
- UMLS CUI [1,2]
- C1519795
Description
Thrombocytes value
Type de données
float
Alias
- UMLS CUI [1]
- C0005821
Description
Leukocytes unit
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0023508
- UMLS CUI [1,2]
- C1519795
Description
Leukocytes value
Type de données
float
Alias
- UMLS CUI [1]
- C1271681
Description
Differentialblutbild
Alias
- UMLS CUI-1
- C0162401
Description
Date of laboratory evaluation
Type de données
date
Alias
- UMLS CUI [1,1]
- C0022885
- UMLS CUI [1,2]
- C0011008
Description
Neutrophiles
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0200633
Description
Blasts
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C0587348
- UMLS CUI [1,2]
- C0005767
Description
Monocytes normal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0026473
- UMLS CUI [1,2]
- C0205307
Description
Monocytes %
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0026473
Description
Eosinophiles normal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0750879
- UMLS CUI [1,2]
- C0205307
Description
Eosinophiles %
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0750879
Description
Basophiles normal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0200641
- UMLS CUI [1,2]
- C0205307
Description
Basophiles %
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Lymphocytes normal
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0200635
- UMLS CUI [1,2]
- C0205307
Description
Lymphocytes %
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0200635
Description
Promyelocytes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0455279
Description
Promyelocytes
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Myelocytes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0455284
Description
Myelocytes
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0455284
Description
Metamyelocytes
Type de données
boolean
Alias
- UMLS CUI [1]
- C0229635
Description
Metamyelocytes
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C0229635
Description
Other cells in differential blood count
Type de données
boolean
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Description
Other cells in differential blood cell count
Type de données
float
Unités de mesure
- %
Alias
- UMLS CUI [1,1]
- C0162401
- UMLS CUI [1,2]
- C0086574
Description
Knochenmarksuntersuchung Tag 26 +/- 2
Alias
- UMLS CUI-1
- C0005957
Description
Date of Bone marrow examination
Type de données
date
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0011008
Description
Bone marrow examination not done
Type de données
boolean
Alias
- UMLS CUI [1]
- C0005957
Description
sample shipping to
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0178913
- UMLS CUI [1,2]
- C0005953
- UMLS CUI [1,3]
- C1524049
Description
Blasts in bone marrow
Type de données
integer
Alias
- UMLS CUI [1]
- C1982687
Description
Blasts in bone marrow >5%
Type de données
integer
Unités de mesure
- %
Alias
- UMLS CUI [1]
- C1982687
Description
Extramedullary AML manifestation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
Description
localisation of extra medullary AML manifestation
Type de données
integer
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0023467
- UMLS CUI [1,3]
- C0475264
Description
other location
Type de données
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C0450429
- UMLS CUI [1,3]
- C0205394
Description
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
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0544452
- UMLS CUI [1,2]
- C0449438
- UMLS CUI [1,3]
- C0023467
Description
Date of relapse
Type de données
date
Alias
- UMLS CUI [1,1]
- C0035020
- UMLS CUI [1,2]
- C0011008
Description
AML Type of relapse
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C0205336
Description
Extramedullary relapse
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0023467
- UMLS CUI [1,2]
- C0035020
- UMLS CUI [1,3]
- C1517060
Description
Other extramedullary relapse manifestation
Type de données
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C1521902
Description
Date of death
Type de données
date
Alias
- UMLS CUI [1]
- C1148348
Description
Unterschrift
Alias
- UMLS CUI-1
- C2346576
Description
Date of investigator signature
Type de données
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Description
Investigator name
Type de données
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Type de données
text
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])