Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome

Moser LM, Hutter M, Ahlmann M, Alonso-Saladrigues A, Attarbaschi A, Ayuk FA, Baldus CD, Balduzzi A, Bonig H, Bourquin JP, Buechner J, Buecklein VL, Burridge S, Calkoen FG, Cario G, De Moerloose B, de Oliveira Canedo G, Dourthe ME, Feuchtinger T, Füreder A, Hauer J, Ifversen M, Jarisch A, Kalwak K, Klusmann JH, Kobbe G, Koenecke C, Künkele A, Meisel R, Merli P, Mielcarek-Siedziuk M, Müller F, Müller I, Napolitano S, Espuelas MO, Penack O, Rabian F, Rossig C, Sauer MG, Schlegel PG, von Stackelberg A, Strahm B, Willier S, Bader P, Rives S, Boissel N, Locatelli F, Ghorashian S, Baruchel A (2026)

Publication Type: Journal article

Publication year: 2026

Journal

DOI: 10.1038/s41375-026-03105-y

Abstract

This multicenter real-world study identifies critical determinants of outcome for tisagenlecleucel (tisa-cel) in treating post-HSCT relapse in 220 children/young adults with B-ALL from 31 European centers. Median follow-up was 30.0 months, with a 43.6% 2-year event-free survival (EFS), 67.2% overall-survival (OS), and 57.1% incidence of CAR-T failure. CAR-T for relapse after transplant from a matched sibling donor (MSD) compared to alternative donors was associated with lower 2-year-OS (MSD 59.1%, mismatched donor MMD 80.2%, matched family/unrelated donor MFD/MUD 68.3%, p = 0.046). Two-year incidence of CAR-T failure was highest for MSD (MSD 73.8%, MFD/MUD 49.7%, MMD 52.2%, p = 0.006). Patients who had relapsed early (< 6 months post HSCT) showed inferior 2-year-EFS (23.7%) and OS (47.2%) compared to patients with late relapse, ≥ 6 months after HSCT (EFS 49.8%, p = 0.001; OS 73.9%, p < 0.001). Early relapse was associated with a higher incidence of CAR-T failure and relapse after tisa-cel, particularly CD19+ relapses. Outcomes correlated with disease burden at lymphodepletion: 2-year-OS was 81.7% for MRD–, 69.2% for MRD+, and 55.2% for patients in non-remission (p = 0.003), with incidence of CAR-T failure highest in non-remission. Prior transplant from an MSD, early post-HSCT relapse, and disease burden at lymphodepletion identify patients at increased risk of CAR-T failure after HSCT.

Authors with CRIS profile

Involved external institutions

University Hospital Ghent Belgium (BE) University College London (UCL) United Kingdom (GB) Hôpital Universitaire Robert-Debré France (FR) Universitätsklinikum Freiburg Germany (DE) Medizinische Universität Wien Austria (AT) Technische Universität München (TUM) Germany (DE) Rigshospitalet Denmark (DK) Universitätsklinikum Frankfurt am Main (KGU) Germany (DE) Wrocław Medical University / Uniwersytet Medyczny we Wrocławiu Poland (PL) Universitätsklinikum Düsseldorf Germany (DE) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Charité - Universitätsmedizin Berlin Germany (DE) Heinrich-Heine-Universität Düsseldorf Germany (DE) Saint Camillus International University of Health Sciences (UniCamillus) Italy (IT) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Fondazione IRCCS San Gerardo dei Tintori Italy (IT) Hôpitaux Universitaires Saint-Louis, Lariboisière, Fernand-Widal France (FR) Universitätsspital Zürich (USZ) Switzerland (CH) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet Norway (NO) Hospital Sant Joan de Déu Barcelona Spain (ES) Institut de recherche Saint-Louis (IRSL) France (FR) Catholic University of the Sacred Heart / Università Cattolica del Sacro Cuore Italy (IT) Universitätsklinikum Münster Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Würzburg Germany (DE) Goethe-Universität Frankfurt am Main Germany (DE) Klinikum der Universität München (LMU Klinikum) Germany (DE) Great Ormond Street Hospital (GOSH) United Kingdom (GB) Princess Máxima Center Netherlands (NL)

How to cite

APA:

Moser, L.M., Hutter, M., Ahlmann, M., Alonso-Saladrigues, A., Attarbaschi, A., Ayuk, F.A.,... Baruchel, A. (2026). Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome. Leukemia. https://doi.org/10.1038/s41375-026-03105-y

MLA:

Moser, Laura M., et al. "Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome." Leukemia (2026).

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