ID
44476
Beskrivning
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
Nyckelord
Versioner (2)
- 2018-01-19 2018-01-19 -
- 2021-09-27 2021-09-27 -
Rättsinnehavare
Technische Universität Dresden,Dr. Röllig
Uppladdad den
27 september 2021
DOI
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Licens
Creative Commons BY-NC 3.0
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AML2003 - Standard-Therapy vs Intensified Therapy for Adult Acute Myeloid Leukemia Patients NCT00180102
Allogene SZT
- 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
Beskrivning
HLA-Kompatibilität
Alias
- UMLS CUI-1
- C0013018
- UMLS CUI-2
- C2348930
Beskrivning
Allogene SZT Konditionierung
Alias
- UMLS CUI-1
- C0376450
- UMLS CUI-2
- C1515895
Beskrivning
Conditioning agent Fludarabin
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0059985
- UMLS CUI [1,2]
- C0376450
Beskrivning
Treatment day fludarabine -6 bis -2
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0059985
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0750480
Beskrivning
Fludarabine daily dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0059985
Beskrivning
Fludarabine cumulative dose
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0059985
Beskrivning
Conditioning agent Melphalan
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0025241
- UMLS CUI [1,2]
- C0376450
Beskrivning
Treatment day Melphalan
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0025241
- UMLS CUI [1,2]
- C0439228
- UMLS CUI [1,3]
- C0750480
Beskrivning
Melphalan daily dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0025241
Beskrivning
Melphalan cumulative dose
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0025241
Beskrivning
(wenn Fremdspender)
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0003442
- UMLS CUI [1,2]
- C0376450
Beskrivning
Treatment day ATG-Fresenius -5bis -2
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C0003442
Beskrivning
ATG-Fresenius daily dose
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C2348070
- UMLS CUI [1,2]
- C0003442
Beskrivning
ATG-Fresenius cumulative dose
Datatyp
integer
Måttenheter
- mg
Alias
- UMLS CUI [1,1]
- C2986497
- UMLS CUI [1,2]
- C0003442
Beskrivning
Other Conditioning agent
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0376450
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C0013227
Beskrivning
Drug Administration Routes
Datatyp
text
Alias
- UMLS CUI [1]
- C0013153
Beskrivning
Treatment day
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0439228
- UMLS CUI [1,2]
- C0750480
Beskrivning
Daily dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2348070
Beskrivning
Cumulative dose
Datatyp
text
Alias
- UMLS CUI [1]
- C2986497
Beskrivning
Transplantat
Alias
- UMLS CUI-1
- C1504389
Beskrivning
Transplant type
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C3840412
- UMLS CUI [1,2]
- C2242529
Beskrivning
nucleated cells
Datatyp
integer
Måttenheter
- *10^8 /kg
Alias
- UMLS CUI [1,1]
- C1180059
- UMLS CUI [1,2]
- C0007584
Beskrivning
CD34+ Cells
Datatyp
integer
Måttenheter
- *10^6/kg
Alias
- UMLS CUI [1]
- C1277788
Beskrivning
CD3 (T-Cells)
Datatyp
integer
Måttenheter
- *10^5 /kg
Alias
- UMLS CUI [1]
- C2025558
Beskrivning
Complete Chimerism within 30 days
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0333678
- UMLS CUI [1,2]
- C3845590
Beskrivning
maximum value
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1,1]
- C0587081
- UMLS CUI [1,2]
- C0806909
Beskrivning
Date of complete chimerism
Datatyp
date
Alias
- UMLS CUI [1,1]
- C3703928
- UMLS CUI [1,2]
- C0011008
Beskrivning
Acute graft versus host disease
Datatyp
integer
Alias
- UMLS CUI [1]
- C0856825
Beskrivning
Gvhd grade skin
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4273340
- UMLS CUI [1,2]
- C0441800
Beskrivning
Gvhd grade colon
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C1334228
- UMLS CUI [1,2]
- C0441800
- UMLS CUI [1,3]
- C0009368
Beskrivning
Gvhd grade liver
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C4273346
- UMLS CUI [1,2]
- C0441800
Beskrivning
Materialversand an Studienzentrale
Alias
- UMLS CUI-1
- C1524049
- UMLS CUI-2
- C0520510
Beskrivning
Bone marrow heparinized
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0005953
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
heparinized pB
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0229664
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
bone marrow smears
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2097112
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
peripheral blood smears
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2238079
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
Date of completion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Beskrivning
Beurteilung Engraftment
Alias
- UMLS CUI-1
- C0301944
- UMLS CUI-2
- C1516048
Beskrivning
Engraftment
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0301944
Beskrivning
3x >0,5 GPt/l bzw . ≥ 500 /μl
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882078
- UMLS CUI [1,2]
- C0011008
Beskrivning
Sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3827885
Beskrivning
3x >20 GPt/l bzw . ≥ 20.000 /μl
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0011008
Beskrivning
Sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3827885
Beskrivning
3x >50 GPt/l bzw . ≥ 50.000 /μl
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1882407
- UMLS CUI [1,2]
- C0011008
Beskrivning
Sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C3827885
Beskrivning
Number red blood cell transfusions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0086252
- UMLS CUI [1,2]
- C0750480
Beskrivning
sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0443318
Beskrivning
Platelet transfusion
Datatyp
integer
Alias
- UMLS CUI [1]
- C0086818
Beskrivning
Count of Platelet transfusions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0086818
- UMLS CUI [1,2]
- C0750480
- UMLS CUI [1,3]
- C1277092
Beskrivning
Sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0443318
Beskrivning
Count of pooled platelet transfusions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0086818
- UMLS CUI [1,2]
- C1277095
- UMLS CUI [1,3]
- C0750480
Beskrivning
Sustained
Datatyp
boolean
Alias
- UMLS CUI [1]
- C0443318
Beskrivning
Count of granulocyte transfusions
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0085430
- UMLS CUI [1,2]
- C0018183
- UMLS CUI [1,3]
- C0750480
Beskrivning
SCT specific adverse events
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0371849
- UMLS CUI [1,2]
- C0877248
Beskrivning
SCT specific adverse event , specify other
Datatyp
text
Alias
- UMLS CUI [1,1]
- C0371849
- UMLS CUI [1,2]
- C0877248
- UMLS CUI [1,3]
- C3845569
Beskrivning
Materialversand an Studienzentrale
Alias
- UMLS CUI-1
- C1524049
- UMLS CUI-2
- C0520510
Beskrivning
Bone marrow heparinized
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0005953
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
heparinized pB
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0019134
- UMLS CUI [1,2]
- C0229664
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
bone marrow smears
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2097112
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
peripheral blood smears
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0205451
- UMLS CUI [1,2]
- C1883469
- UMLS CUI [1,3]
- C2238079
Beskrivning
Shipping date
Datatyp
date
Alias
- UMLS CUI [1,1]
- C1524049
- UMLS CUI [1,2]
- C0011008
Beskrivning
KM-Morphologie
Alias
- UMLS CUI-1
- C2704380
Beskrivning
Bone marrow examination done?
Datatyp
boolean
Alias
- UMLS CUI [1,1]
- C0005957
- UMLS CUI [1,2]
- C0884358
Beskrivning
Date
Datatyp
date
Alias
- UMLS CUI [1]
- C0011008
Beskrivning
Not done reason
Datatyp
text
Alias
- UMLS CUI [1]
- C2826287
Beskrivning
Blasts in Bone marrow
Datatyp
integer
Måttenheter
- %
Alias
- UMLS CUI [1]
- C1982687
Beskrivning
Laboratory Name
Datatyp
text
Alias
- UMLS CUI [1]
- C1882331
Beskrivning
Beurteilung des Therapieerfolges
Alias
- UMLS CUI-1
- C0085565
Beskrivning
Status post SCT
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0371849
- UMLS CUI [1,2]
- C0085415
Beskrivning
SCT associated death day number post-treatment
Datatyp
integer
Alias
- UMLS CUI [1,1]
- C0371849
- UMLS CUI [1,2]
- C0206277
- UMLS CUI [1,3]
- C2709088
Beskrivning
Date of completion
Datatyp
date
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C0850287
Beskrivning
Investigator name
Datatyp
text
Alias
- UMLS CUI [1]
- C2826892
Beskrivning
Investigator Signature
Datatyp
text
Alias
- UMLS CUI [1]
- C2346576
Similar models
Allogene SZT
- 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
C2348930 (UMLS CUI [1,2])
(Comment:de)
(Comment:de)
(Comment:de)
C1515895 (UMLS CUI-2)
C0376450 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0059985 (UMLS CUI [1,2])
C0059985 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,2])
C0439228 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0025241 (UMLS CUI [1,2])
C0025241 (UMLS CUI [1,2])
C0376450 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0003442 (UMLS CUI [1,3])
C0003442 (UMLS CUI [1,2])
C0003442 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C0013227 (UMLS CUI [1,3])
C0750480 (UMLS CUI [1,2])
C2242529 (UMLS CUI [1,2])
C0007584 (UMLS CUI [1,2])
C3845590 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0441800 (UMLS CUI [1,2])
C0009368 (UMLS CUI [1,3])
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])
C0850287 (UMLS CUI [1,2])
C1516048 (UMLS CUI-2)
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,2])
C1277092 (UMLS CUI [1,3])
C1277095 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0018183 (UMLS CUI [1,2])
C0750480 (UMLS CUI [1,3])
C0877248 (UMLS CUI [1,2])
C0877248 (UMLS CUI [1,2])
C3845569 (UMLS CUI [1,3])
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])
C0085415 (UMLS CUI [1,2])
C0206277 (UMLS CUI [1,2])
C2709088 (UMLS CUI [1,3])
C0850287 (UMLS CUI [1,2])