Haematopoietic Stem Cell Transplantation (HSCT) in Comparison to Conventional Consolidation Therapy for Patients With Acute Myeloid Leukemia (AML) (Intermediate Risk) </= 60y. After First CR
NCT ID: NCT01246752
Last Updated: 2021-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
143 participants
INTERVENTIONAL
2011-02-10
2020-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Human Stem Cell Transplantation
Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor
Human Stem Cell Transplantation
Human allogenic stem cells
Consolidating Chemotherapy
Patients receive a standard chemotherapy as consolidation therapy
Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
Interventions
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Human Stem Cell Transplantation
Human allogenic stem cells
Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC)
Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* age: 18 - 60 years
* medically fit for allogeneic stem cell transplantation
* CR / CRi after induction therapy
* core-binding factor leukemia (t(8;21), inv16)
* acute promyelocytic leukemia (t(15;17)
* complex aberrant karyotype
* karyotypes: -7; -5; del5q; t(3;3); t(6;11), t(6;9), 11q aberrations, trisomy 8 ± one single additional aberration
* pregnancy / nursing
* non-compliance
18 Years
60 Years
ALL
No
Sponsors
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German Research Foundation
OTHER
University Hospital Carl Gustav Carus
OTHER
Responsible Party
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Principal Investigators
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Martin Bornhaeuser, Prof. (MD)
Role: PRINCIPAL_INVESTIGATOR
Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany
Locations
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Universitätsklinikum Aachen
Aachen, , Germany
Klinikum Augsburg
Augsburg, , Germany
Klinikum Chemnitz gGmbH
Chemnitz, , Germany
University Hospital Carl Gustav Carus
Dresden, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Universitätsklinikum Essen - Westdeutsches Tumorzentrum
Essen, , Germany
Klinikum Frankfurt (Oder) GmbH
Frankfurt (Oder), , Germany
Klinikum der Johann-Wolfgang-Goethe Universität
Frankfurt am Main, , Germany
Universitätsklinikum Halle
Halle, , Germany
Asklepios Klinik St. Georg
Hamburg, , Germany
Universitaetsklinikum Leipzig - AöR
Leipzig, , Germany
Universitätsklinikum Magdeburg
Magdeburg, , Germany
Universitätsklinikum Mannheim
Mannheim, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Marburg, , Germany
Klinikum der LMU Universität - Campus Großhadern
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
Städtisches Klinikum Nord
Nuremberg, , Germany
Ernst-von-Bergmann-Klinikum Potsdam
Potsdam, , Germany
Robert-Bosch-Krankenhaus
Stuttgart, , Germany
Countries
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References
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Bornhauser M, Schliemann C, Schetelig J, Rollig C, Kramer M, Glass B, Platzbecker U, Burchert A, Hanel M, Muller LP, Klein S, Bug G, Beelen D, Rosler W, Schafer-Eckart K, Schmid C, Jost E, Lenz G, Tischer J, Spiekermann K, Pfirrmann M, Serve H, Stolzel F, Alakel N, Middeke JM, Thiede C, Ehninger G, Berdel WE, Stelljes M. Allogeneic Hematopoietic Cell Transplantation vs Standard Consolidation Chemotherapy in Patients With Intermediate-Risk Acute Myeloid Leukemia: A Randomized Clinical Trial. JAMA Oncol. 2023 Apr 1;9(4):519-526. doi: 10.1001/jamaoncol.2022.7605.
Related Links
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Study Alliance Leukemia (coordinating study group)
Other Identifiers
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TUD-ETAL-1-045
Identifier Type: -
Identifier Source: org_study_id