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decreased recrucial rate as the likelihood of achieving the envisioned patient number in a realistic time-frame was very low.
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| Name | Class |
|---|---|
| German Research Foundation | OTHER |
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Hematopoietic stem cell transplantation in patients with newly diagnosed AML ≤60 years of age in intermediate risk, after first complete response in comparison to standard consolidation chemotherapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human Stem Cell Transplantation | Experimental | Patients receive an allogenic stem cell transplantation from an HLA-matched unrelated or related donor |
|
| Consolidating Chemotherapy | Active Comparator | Patients receive a standard chemotherapy as consolidation therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human Stem Cell Transplantation | Biological | Human allogenic stem cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Patients alive after 4 years (Overall Survival) | The status of each patient alive/not alive is surveyed every 3 months in year 1+2 and every 6 months in year 3+4 after randomisation. | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 4 years | |
| Cumulative incidence of relapse | 4 years | |
| Cumulative incidence of non-relapse mortality |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bornhaeuser, Prof. (MD) | Universitätsklinikum Dresden, Medizinische Klinik und Poliklinik I, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Aachen | Aachen | Germany | ||||
| Klinikum Augsburg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36757706 | Derived | 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. |
| Label | URL |
|---|---|
| Study Alliance Leukemia (coordinating study group) | View source |
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| Consolidation chemotherapy, i.e. High-dose Cytarabine (HiDAC) | Drug | Consolidation chemotherapy, recommended regimen: HiDAC = 3 x 2g/sqm BID on days 1,3,5 |
|
| 4 years |
| Quality of life assessed by questionnaires | Scores assessed by validated questionnaires (8 subscales: physical function, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health) | 4 years |
| Augsburg |
| Germany |
| Klinikum Chemnitz gGmbH | Chemnitz | Germany |
| University Hospital Carl Gustav Carus | Dresden | 01307 | 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 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D060830 | Consolidation Chemotherapy |
| D003561 | Cytarabine |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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