Treatment sequence with gilteritinib and allogeneic haematopoietic stem cell transplantation in relapsed/refractory FMS-like tyrosine kinase 3 (FLT3)-mutated acute myeloid leukaemia patients: A multicentre real-world study.

Authors

Desiree Kunadt, Sven Zukunft, Christoph Röllig, Stephan Metzelder, Andreas Burchert, Eva Wagner-Drouet, Oliver Kriege, Christoph Schliemann, Matthias Stelljes, Julian Ronnacker, Wolfgang Bethge, Jan Frederic Weller, Björn Steffen, Gesine Bug, Khouloud Kouidri, Claudia Baldus, Lars Fransecky, Elisa Sala, Uwe Platzbecker, Klaus Metzeler, Sabine Kayser, Inken Hilgendorf, Andreas Hochhaus, Tim H Brümmendorf, Edgar Jost, Anna Dorottya Doleschall, Thomas Schroeder, Jennifer Kaivers, Lambros Kordelas, Udo Holtick, Julia M Unglaub, Tim Sauer, Paul Sebastian Jäger, Guido Kobbe, Elena Stauffer, Johanna Tischer, Tobias Herold, Normann Steiner, David Nachbaur, Nicolaus Kröger, Jochen J Frietsch, Sabrina Kraus, Hermann Einsele, Mathias Hänel, Judith Schaffrath, William Krüger, Anne Brandenburg, Tobias A W Holderried, Laura Reinhardt, Markus Maulhardt, Christian Thiede, Martin Bornhäuser, Johannes Schetelig, Jan M Middeke, Friedrich Stölzel, German Cooperative Transplant Study Group and Study Alliance Leukemia (SAL)

Published in

British journal of haematology. Aug 18, 2026. Epub Aug 18, 2026.

Abstract

Patients with relapsed or refractory acute myeloid leukaemia (r/r AML) harbouring FMS-like tyrosine kinase 3 (FLT3) mutations generally have poor prognosis and limited treatment options. The second-generation FLT3 inhibitor gilteritinib provides better disease control compared to standard relapse therapies and was approved based on two randomized trials. We analysed its efficacy and safety in a real-world cohort of r/r AML patients undergoing gilteritinib treatment including allogeneic haematopoietic stem cell transplantation (alloHSCT). Data were collected from all consecutive r/r AML patients with FLT3-internal tandem duplication and/or FLT3-tyrosine kinase domain mutations receiving gilteritinib at 25 centres. Response and survival were analysed using descriptive and correlative statistics. A total of 156 patients were analysed, 55.1% with relapse after previous alloHSCT, and 46.2% with prior FLT3 inhibitor exposure. The overall complete remission/incomplete remission (CR/Cri) rate was 45.3%, with a median overall survival (OS) of 10.0 months. Patients receiving gilteritinib only had a 1-year OS of 34%, while those with consolidating alloHSCT had a 1-year OS of 76%-92%, depending on gilteritinib maintenance post-transplant. Resuming gilteritinib post-transplant led to an 85.7% CR/CRi rate. Our real-world data confirm that gilteritinib is an effective single-agent therapy for r/r AML with FLT3 mutations, with best outcomes when used as a bridge to transplant and post-transplant maintenance.

PMID:
42610785
Bibliographic data and abstract were imported from PubMed on 18 Aug 2026.

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