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2. Allogeneic hematopoietic SCT in patients with AML following treosulfan/fludarabine conditioning.

Author

Casper, J, Holowiecki, J, Trenschel, R, Wandt, H, Schaefer-Eckart, K, Ruutu, T, Volin, L, Einsele, H, Stuhler, G, Uharek, L, Blau, I, Bornhaeuser, M, Zander, A R, Larsson, K, Markiewicz, M, Giebel, S, Kruzel, T, Mylius, H A, Baumgart, J, and Pichlmeier, U

Subjects
FLUDARABINE, TREATMENT effectiveness, ACUTE myeloid leukemia treatment, GRAFT versus host disease, HEMATOPOIETIC stem cell transplantation
Abstract

An alternative reduced-toxicity conditioning regimen for allogeneic transplantation, based on treosulfan and fludarabine, has recently been identified. The safety and efficacy of this new conditioning regimen has been investigated prospectively in patients with AML. A total number of 75 patients with AML in CR were treated with 3 × 14 g/m2 treosulfan and 5 × 30 mg/m2 fludarabine, followed by matched sibling or unrelated SCT. Patients were evaluated for engraftment, adverse events, GVHD, and for non-relapse mortality, relapse incidence, overall and disease-free survival (DFS). All patients showed primary engraftment of neutrophils after a median of 20 days. Non-hematological adverse events grade III-IV in severity included mainly infections (59%) and gastrointestinal symptoms (7%). Acute GVHD grade II-IV occurred in 21% and extensive chronic GVHD occurred in 16% of the patients. After a median follow-up of 715 days, the 2-year overall and DFS estimates were 61% and 55%, respectively. The 2-year incidences of relapse and non-relapse mortality reached 34% and 11%, respectively. In summary, our data confirm promising safety and efficacy of the treosulfan-based conditioning therapy in AML patients, ClinicalTrials.gov Identifier: NCT01063660. [ABSTRACT FROM AUTHOR]

Published
2012
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3. 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

Author

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, 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., and Markiewicz, M.

Subjects
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
Abstract

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

Published
2020

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