ID
44476
Beschrijving
NCT00180102 AML2003 is a prospective randomized trial, to investigate the value of early allogeneic stem cell transplantation in aplasia after induction therapy for high risk patients with acute myeloid leukemia. Phase 4 Study Type:Interventional Study Design:Allocation: Randomized Intervention Model:Factorial Assignment Masking:None (Open Label) Primary Purpose:Treatment Medical Department I, University Hospital Carl Gustav Carus Dresden, Germany, 01307 Sponsors and Collaborators Technische Universität Dresden Principal Investigator:Gerhard Ehninger, MD University Hospital Carl Gustav Carus Dresden
Trefwoorden
Versies (2)
- 19-01-18 19-01-18 -
- 27-09-21 27-09-21 -
Houder van rechten
Technische Universität Dresden,Dr. Röllig
Geüploaded op
27 september 2021
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
Model Commentaren :
Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.
Itemgroep Commentaren voor :
Item Commentaren voor :
U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.
AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102
nach 2. Induktionstherapie
- StudyEvent: ODM
- Eligibility criteria
- Ersterhebung
- Diagnostik vor Therapiebeginn
- 1. Induktionstherapie (DA)
- Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-
- nach 1. Induktionstherapie
- 2. Induktionstherapie (DA)
- 2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Induktionstherapie
- 1. Postremissionstherapie (Ara-C/MAC)
- 1. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 1. Postremissionstherapie
- 2. Postremissionstherapie (Ara-C/MAMAC)
- 2. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Postremissionstherapie
- 3. Postremissionstherapie (Ara-C/MAC)
- 3. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 3. Postremissionstherapie
- Vor Stammzelltransplantation (SZT)
- Autologe SZT
- Allogene SZT
- SZT - Unerwünschte Ereignisse CTC 3.0 -
- Follow-up
- Rezidivbogen
- Schweres unerwünschtes Ereignis - SUE
Beschrijving
Blutbild
Alias
- UMLS CUI-1
- C0005771
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Leukocytes
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Hemoglobin
Datatype
integer
Alias
- UMLS CUI [1]
- C0518015
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Blood platelets
Datatype
float
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Neutrophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0948762
Beschrijving
Segmented neutrophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0942466
Beschrijving
Band neutrophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C1882076
Beschrijving
Lymphocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200635
Beschrijving
Monocytes
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200637
Beschrijving
Eosinophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200638
Beschrijving
Basophils
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0200641
Beschrijving
Myeloblasts
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0229633
Beschrijving
Promyelocyte count
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455279
Beschrijving
Myelocyte count
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455284
Beschrijving
Metamyelocyte count
Datatype
float
Maateenheden
- %
Alias
- UMLS CUI [1]
- C0455285
Beschrijving
Klinische Chemie
Alias
- UMLS CUI-1
- C0008000
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Creatinine measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0201975
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Bilirubin measurement
Datatype
integer
Alias
- UMLS CUI [1]
- C0344395
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
AP
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
GOT/ASAT [umol/s*l]
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
GPT/ALAT
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
LDH
Datatype
float
Alias
- UMLS CUI [1]
- C0202113
Beschrijving
Unit of measure
Datatype
integer
Alias
- UMLS CUI [1]
- C1519795
Beschrijving
Total proteine
Datatype
float
Maateenheden
- g/L
Alias
- UMLS CUI [1]
- C0555903
Beschrijving
KM-Morphologie
Alias
- UMLS CUI-1
- C2704380
Beschrijving
Bone marrow examination done?
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0884358
Beschrijving
Date
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Not done reason
Datatype
text
Alias
- UMLS CUI [1]
- C2826287
Beschrijving
Blasts in Bone marrow
Datatype
integer
Maateenheden
- %
Alias
- UMLS CUI [1]
- C1982687
Beschrijving
Laboratory Name
Datatype
text
Alias
- UMLS CUI [1]
- C1882331
Beschrijving
Beurteilung des Therapieerfolges
Alias
- UMLS CUI-1
- C0085565
Beschrijving
Treatment outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C0085565
Beschrijving
Specify reason for evaluation impossible
Datatype
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0220825
- UMLS CUI [1,3]
- C1272705
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Beschrijving
Risikogruppeneinteilung
Alias
- UMLS CUI-1
- C0035648
Beschrijving
Low risk aberrations
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C3538919
Beschrijving
High risk aberrations
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0008625
- UMLS CUI [1,2]
- C0684030
Beschrijving
Stem cell donor
Datatype
integer
Alias
- UMLS CUI [1]
- C0375877
Beschrijving
Stem cell donor relation type
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0375877
- UMLS CUI [1,2]
- C0369128
Beschrijving
Stem cell transplantation planned
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C1301732
Beschrijving
Stem cell transplantation center
Datatype
text
Alias
- UMLS CUI [1,1]
- C1504389
- UMLS CUI [1,2]
- C0565990
Beschrijving
Geplante 1. Postremissionstherapie
Alias
- UMLS CUI-1
- C1511484
- UMLS CUI-2
- C1301732
Beschrijving
Planned first consolidation treatment trial arms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C3538919
Beschrijving
Planned Consolidation treatment trial arm B
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3538919
- UMLS CUI [1,2]
- C1522541
Beschrijving
Planned Consolidation treatment trial arm D
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3538919
- UMLS CUI [1,2]
- C1522541
Beschrijving
Planned first consolidation treatment trial arms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C1998074
Beschrijving
Chemotherapie number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0237753
Beschrijving
Standart risk trial arm B
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1998074
- UMLS CUI [1,2]
- C1522541
Beschrijving
Standart risk trial arm D
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1998074
- UMLS CUI [1,2]
- C1522541
Beschrijving
Planned first consolidation treatment trial arms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C1522541
- UMLS CUI [1,3]
- C0684030
Beschrijving
Chemotherapy number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0392920
- UMLS CUI [1,2]
- C0237753
Beschrijving
High risk trial arm B
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0684030
- UMLS CUI [1,2]
- C1522541
Beschrijving
High risk trial arm D
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0684030
- UMLS CUI [1,2]
- C1522541
Beschrijving
Geplante 1. Postremissionstherapie
Alias
- UMLS CUI-1
- C1511484
- UMLS CUI-2
- C1301732
Beschrijving
planned first consolidation treatment trial arm
Datatype
integer
Alias
- UMLS CUI [1]
- C1522541
Beschrijving
Planned first consolidation treatment t(8;21) trial arm A
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Beschrijving
Planned first consolidation treatment t(8;21) trial arm C
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Beschrijving
without t(8;21) no complex caryotype trial arm A
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
Beschrijving
Planned first consolidation treatment without t(8;21) no complex karyotype family donor availableboth arms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0333683
- UMLS CUI [1,2]
- C0375877
- UMLS CUI [1,3]
- C0470187
Beschrijving
Planned first consolidation treatment without t(8;21) no complex karyotype without family donor trial arm A
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Beschrijving
Planned first consolidation treatment without t(8;21) no complex karyotype without family donor trial arm C
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Beschrijving
Planned Consolidation treatment complex caryotype trial arm A
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1511484
- UMLS CUI [1,2]
- C3273253
Beschrijving
planned consolidation treatment Complex karyotype stem cell donor available both arms
Datatype
integer
Alias
- UMLS CUI [1,1]
- C3273253
- UMLS CUI [1,2]
- C0375877
- UMLS CUI [1,3]
- C0470187
Beschrijving
Planned first consolidation treatment complex karyotype no stem cell donor available trail arm A
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Beschrijving
Planned first consolidation treatment complex karyotype no stem cell donor available trail arm C
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1522541
- UMLS CUI [1,2]
- C0333683
- UMLS CUI [1,3]
- C0375877
- UMLS CUI [1,4]
- C0686905
Beschrijving
Date of completion
Datatype
date
Alias
- UMLS CUI [1]
- C0011008
Beschrijving
Investigator name
Datatype
text
Alias
- UMLS CUI [1]
- C2826892
Beschrijving
Investigator Signature
Datatype
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
nach 2. Induktionstherapie
- StudyEvent: ODM
- Eligibility criteria
- Ersterhebung
- Diagnostik vor Therapiebeginn
- 1. Induktionstherapie (DA)
- Induktionstherapie -Unerwünschte Ereignisse CTC 3.0-
- nach 1. Induktionstherapie
- 2. Induktionstherapie (DA)
- 2. Induktionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Induktionstherapie
- 1. Postremissionstherapie (Ara-C/MAC)
- 1. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 1. Postremissionstherapie
- 2. Postremissionstherapie (Ara-C/MAMAC)
- 2. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 2. Postremissionstherapie
- 3. Postremissionstherapie (Ara-C/MAC)
- 3. Postremissionstherapie - Unerwünschte Ereignisse CTC 3.0 -
- nach 3. Postremissionstherapie
- Vor Stammzelltransplantation (SZT)
- Autologe SZT
- Allogene SZT
- SZT - Unerwünschte Ereignisse CTC 3.0 -
- Follow-up
- Rezidivbogen
- Schweres unerwünschtes Ereignis - SUE
C0520510 (UMLS CUI-2)
C0005953 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0229664 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1883469 (UMLS CUI [1,2])
C2097112 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C1883469 (UMLS CUI [1,2])
C2238079 (UMLS CUI [1,3])
C0011008 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0220825 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
C0369128 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,2])
C0565990 (UMLS CUI [1,2])
C1301732 (UMLS CUI-2)
C1522541 (UMLS CUI [1,2])
C3538919 (UMLS CUI [1,3])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1998074 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C0684030 (UMLS CUI [1,3])
C0237753 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1522541 (UMLS CUI [1,2])
C1301732 (UMLS CUI-2)
C0333683 (UMLS CUI [1,2])
C0333683 (UMLS CUI [1,2])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C3273253 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
C0333683 (UMLS CUI [1,2])
C0375877 (UMLS CUI [1,3])
C0686905 (UMLS CUI [1,4])
Geen commentaren