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

Publication date: Available online 9 October 2019Source: The Lancet HaematologyAuthor(s): Dietrich Wilhelm Beelen, Rudolf Trenschel, Matthias Stelljes, Christoph Groth, Tamás Masszi, Péter Reményi, Eva-Maria Wagner-Drouet, Beate Hauptrock, Peter Dreger, Thomas Luft, Wolfgang Bethge, Wichard Vogel, Fabio Ciceri, Jacopo Peccatori, Friedrich Stölzel, Johannes Schetelig, Christian Junghanß, Christina Grosse-Thie, Mauricette Michallet, Hélène Labussiere-WalletSummaryBackgroundFurther 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.MethodsWe 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 <5% in bone marrow) or myelodysplastic syndrome (blast counts <20% in bone marrow), Karnofsky index of 60% or higher, and were indicated for allogeneic HSCT but considered at an increased risk for standard myeloablative preparative regimens based on age (≥50 years), an HSCT-specific comorbidity index of...
Source: The Lancet Haematology - Category: Hematology Source Type: research