ID
28493
Description
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
Keywords
Versions (2)
- 1/19/18 1/19/18 -
- 9/27/21 9/27/21 -
Copyright Holder
Technische Universität Dresden,Dr. Röllig
Uploaded on
January 19, 2018
DOI
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License
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
Description
Materialversand an Studienzentrale
Alias
- UMLS CUI-1
- C1524049
- UMLS CUI-2
- C0520510
Description
Bone marrow heparinized
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0005953
Description
Shipping date
Data type
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Description
heparinized pB
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0229664
Description
Shipping date
Data type
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Description
bone marrow smears
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2097112
Description
Shipping date
Data type
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Description
peripheral blood smears
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2238079
Description
Shipping date
Data type
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Description
Recidiv diagnosis date
Data type
date
Alias
- UMLS CUI [1,1]
- C2316983
- UMLS CUI [1,2]
- C0034897
Description
Recidiv number
Data type
integer
Alias
- UMLS CUI [1,1]
- C0034897
- UMLS CUI [1,2]
- C0750480
Description
Ort des Rezidivs
Alias
- UMLS CUI-1
- C0034897
- UMLS CUI-2
- C0450429
Description
Blutbild
Alias
- UMLS CUI-1
- C0005771
Description
date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Leukocytes
Data type
float
Alias
- UMLS CUI [1]
- C0023508
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Hemoglobin
Data type
integer
Alias
- UMLS CUI [1]
- C0518015
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Blood platelets
Data type
float
Alias
- UMLS CUI [1]
- C0032181
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Date of differential blood count
Data type
date
Alias
- UMLS CUI [1,1]
- C0545131
- UMLS CUI [1,2]
- C0011008
Description
Neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0948762
Description
Segmented neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0942466
Description
Band neutrophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C1882076
Description
Lymphocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200635
Description
Monocytes
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200637
Description
Eosinophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200638
Description
Basophils
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0200641
Description
Myeloblasts
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0580952
Description
Promyelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455279
Description
Myelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455284
Description
Metamyelocyte count
Data type
float
Measurement units
- %
Alias
- UMLS CUI [1]
- C0455285
Description
Klinische Chemie
Alias
- UMLS CUI-1
- C0008000
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Creatinine measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0201975
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
bilirubin measurement
Data type
integer
Alias
- UMLS CUI [1]
- C0344395
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
AP
Data type
float
Alias
- UMLS CUI [1]
- C0201850
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
GOT/ASAT [umol/s*l]
Data type
float
Alias
- UMLS CUI [1]
- C0201899
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
GPT/ALAT
Data type
float
Alias
- UMLS CUI [1]
- C0201836
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
LDH
Data type
float
Alias
- UMLS CUI [1]
- C0202113
Description
Unit of measure
Data type
integer
Alias
- UMLS CUI [1]
- C1519795
Description
Total proteine
Data type
float
Measurement units
- g/L
Alias
- UMLS CUI [1]
- C0555903
Description
Klinischer Befund
Alias
- UMLS CUI-1
- C2607943
Description
Hemorrhage
Data type
boolean
Alias
- UMLS CUI [1]
- C0019080
Description
Infections
Data type
boolean
Alias
- UMLS CUI [1]
- C0009450
Description
Fever
Data type
boolean
Alias
- UMLS CUI [1]
- C0015967
Description
Gingival Hyperplasia
Data type
boolean
Alias
- UMLS CUI [1]
- C0017566
Description
Lymphoma
Data type
boolean
Alias
- UMLS CUI [1]
- C0024299
Description
Liver size
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0426688
- UMLS CUI [1,2]
- C0041618
Description
size of spleen
Data type
integer
Measurement units
- cm
Alias
- UMLS CUI [1,1]
- C0412541
- UMLS CUI [1,2]
- C0552406
Description
extramedullary manifestation
Data type
boolean
Alias
- UMLS CUI [1]
- C1868812
Description
extramedullary manifestation localization
Data type
text
Alias
- UMLS CUI [1,1]
- C1868812
- UMLS CUI [1,2]
- C1521902
Description
other symptoms
Data type
text
Alias
- UMLS CUI [1,1]
- C1457887
- UMLS CUI [1,2]
- C0205394
Description
KM-Morphologie
Alias
- UMLS CUI-1
- C2704380
Description
Bone marrow examination done?
Data type
boolean
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0884358
Description
Date
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Not done reason
Data type
text
Alias
- UMLS CUI [1]
- C2826287
Description
Blasts in Bone marrow
Data type
integer
Measurement units
- %
Alias
- UMLS CUI [1]
- C1982687
Description
Laboratory Name
Data type
text
Alias
- UMLS CUI [1]
- C1882331
Description
Rezidiv Behandlung
Alias
- UMLS CUI-1
- C0040808
- UMLS CUI-2
- C0277556
Description
Beurteilung des Therapieerfolges
Alias
- UMLS CUI-1
- C0085565
Description
Outcome assessment date
Data type
date
Alias
- UMLS CUI [1,1]
- C0085565
- UMLS CUI [1,2]
- C2985720
Description
Treatment outcome
Data type
integer
Alias
- UMLS CUI [1]
- C0085565
Description
Date of completion
Data type
date
Alias
- UMLS CUI [1]
- C0011008
Description
Investigator name
Data type
text
Alias
- UMLS CUI [1]
- C2826892
Description
Investigator signature
Data type
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])