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
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Licentie
Creative Commons BY-NC 3.0
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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102
Rezidivbogen
- 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
Materialversand an Studienzentrale
Alias
- UMLS CUI-1
- C1524049
- UMLS CUI-2
- C0520510
Beschrijving
Bone marrow heparinized
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0005953
Beschrijving
Shipping date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beschrijving
heparinized pB
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0229664
Beschrijving
Shipping date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beschrijving
bone marrow smears
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2097112
Beschrijving
Shipping date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beschrijving
peripheral blood smears
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2238079
Beschrijving
Shipping date
Datatype
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beschrijving
Recidiv diagnosis date
Datatype
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0034897
Beschrijving
Recidiv number
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0750480
Beschrijving
Ort des Rezidivs
Alias
- UMLS CUI-1
- C0034897
- UMLS CUI-2
- C0450429
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
Date of differential blood count
Datatype
date
Alias
- UMLS CUI [1,1]
- C0545131
- UMLS CUI [1,2]
- C0011008
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]
- C0580952
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
Klinischer Befund
Alias
- UMLS CUI-1
- C2607943
Beschrijving
Hemorrhage
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019080
Beschrijving
Infections
Datatype
boolean
Alias
- UMLS CUI [1]
- C0009450
Beschrijving
Fever
Datatype
boolean
Alias
- UMLS CUI [1]
- C0015967
Beschrijving
Gingival Hyperplasia
Datatype
boolean
Alias
- UMLS CUI [1]
- C0017566
Beschrijving
Lymphoma
Datatype
boolean
Alias
- UMLS CUI [1]
- C0024299
Beschrijving
Liver size
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0041618
Beschrijving
size of spleen
Datatype
integer
Maateenheden
- cm
Alias
- UMLS CUI [1,1]
- C0412541
- UMLS CUI [1,2]
- C0552406
Beschrijving
extramedullary manifestation
Datatype
boolean
Alias
- UMLS CUI [1]
- C1868812
Beschrijving
extramedullary manifestation localization
Datatype
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C1521902
Beschrijving
other symptoms
Datatype
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205394
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
Rezidiv Behandlung
Alias
- UMLS CUI-1
- C0040808
- UMLS CUI-2
- C0277556
Beschrijving
Beurteilung des Therapieerfolges
Alias
- UMLS CUI-1
- C0085565
Beschrijving
Outcome assessment date
Datatype
date
Alias
- UMLS CUI [1,1]
- C0085565
- UMLS CUI [1,2]
- C2985720
Beschrijving
Treatment outcome
Datatype
integer
Alias
- UMLS CUI [1]
- C0085565
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
Rezidivbogen
- 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])
C0034897 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0041618 (UMLS CUI [1,2])
C0552406 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,2])
C0277556 (UMLS CUI-2)
C0040808 (UMLS CUI [1,2])
C2985720 (UMLS CUI [1,2])