Treosulfan or busulfan plus fludarabine as conditioning treatment before allogeneic haemopoietic stem cell transplantation for older patients with acute myeloid leukaemia or myelodysplastic syndrome (MC-FludT.14/L): a randomised, non-inferiority, phase 3 trial
| Autor: | Christian Junghanß, Christoph Groth, Nadezda Basara, Sandra Grass, Anja Klein, Inken Hilgendorf, Dietger Niederwieser, Sabine Dressler, Domenico Russo, Matthias Stelljes, Miroslaw Markiewicz, Beate Hauptrock, Daniel Wolff, Christof Scheid, Hélène Labussière-Wallet, Ernst Holler, Wichard Vogel, Peter Dreger, Kerstin Schaefer-Eckart, Heidrun A. Mylius, Goetz Ulrich Grigoleit, Maria Caterina Micò, Joachim Baumgart, Jochen Casper, Fabio Ciceri, Thomas Luft, Dietrich W. Beelen, Anna Paola Iori, Alessandro Rambaldi, Gernot Stuhler, Péter Reményi, Maria Bieniaszewska, Marta Medeot, Tamás Masszi, Nils Rudolf Winkelmann, Udo Holtick, Jacopo Peccatori, Uwe Pichlmeier, Mauricette Michallet, Friedrich Stölzel, Eva Maria Wagner-Drouet, Fabio Benedetti, Stephan Mielke, Johannes Schetelig, Régis Peffault de Latour, Wolfgang Bethge, Georg Nikolaus Franke, Michael Tribanek, Monika Dzierzak-Mietla, Helge Menzel, Gérard Socié, Rudolf Trenschel, Gerald Wulf, Bertram Glass, Christina Grosse-Thie, Mareike Verbeek, Juergen Finke, Francesca Patriarca, Claudia Hemmelmann |
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| Přispěvatelé: | Beelen, D. W., Trenschel, R., Stelljes, M., Groth, C., Masszi, T., Remenyi, P., Wagner-Drouet, E. -M., Hauptrock, B., Dreger, P., Luft, T., Bethge, W., Vogel, W., Ciceri, F., Peccatori, J., Stolzel, F., Schetelig, J., Junghanss, C., Grosse-Thie, C., Michallet, M., Labussiere-Wallet, H., Schaefer-Eckart, K., Dressler, S., Grigoleit, G. U., Mielke, S., Scheid, C., Holtick, U., Patriarca, F., Medeot, M., Rambaldi, A., Mico, M. C., Niederwieser, D., Franke, G. -N., Hilgendorf, I., Winkelmann, N. R., Russo, D., Socie, G., Peffault de Latour, R., Holler, E., Wolff, D., Glass, B., Casper, J., Wulf, G., Menzel, H., Basara, N., Bieniaszewska, M., Stuhler, G., Verbeek, M., Grass, S., Iori, A. P., Finke, J., Benedetti, F., Pichlmeier, U., Hemmelmann, C., Tribanek, M., Klein, A., Mylius, H. A., Baumgart, J., Dzierzak-Mietla, M., Markiewicz, M. |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty Transplantation Conditioning Population Medizin Antineoplastic Agents Treosulfan Disease-Free Survival 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Humans education Busulfan Preparative Regimen Aged education.field_of_study business.industry Hematopoietic Stem Cell Transplantation Hematology Middle Aged Interim analysis 3. Good health Fludarabine Transplantation Regimen Leukemia Myeloid Acute 030220 oncology & carcinogenesis Myelodysplastic Syndromes Female business Vidarabine 030215 immunology medicine.drug |
| Popis: | Background: Further improvement of preparative regimens before allogeneic haemopoietic stem cell transplantation (HSCT) is an unmet medical need for the growing number of older or comorbid patients with acute myeloid leukaemia or myelodysplastic syndrome. We aimed to evaluate the efficacy and safety of conditioning with treosulfan plus fludarabine compared with reduced-intensity busulfan plus fludarabine in this population. Methods: We did an open-label, randomised, non-inferiority, phase 3 trial in 31 transplantation centres in France, Germany, Hungary, Italy, and Poland. Eligible patients were 18–70 years, had acute myeloid leukaemia in first or consecutive complete haematological remission (blast counts |
| Databáze: | OpenAIRE |
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