%0 Journal Article %A Apostolova, Petya %A Kreutmair, Stefanie %A Toffalori, Cristina %A Punta, Marco %A Unger, Susanne %A Burk, Ann-Cathrin %A Wehr, Claudia %A Maas-Bauer, Kristina %A Melchinger, Wolfgang %A Haring, Eileen %A Hoefflin, Rouven %A Shoumariyeh, Khalid %A Hupfer, Valerie %A Lauer, Eliza Maria %A Duquesne, Sandra %A Lowinus, Theresa %A Gonzalo Núñez, Nicolás %A Alberti, Chiara %A da Costa Pereira, Sara %A Merten, Carla Helena %A Power, Laura %A Weiss, Matthias %A Böke, Caroline %A Pfeifer, Dietmar %A Marks, Reinhard %A Bertz, Hartmut %A Wäsch, Ralph %A Ihorst, Gabriele %A Gentner, Bernhard %A Duyster, Justus %A Börries, Melanie %A Andrieux, Geoffroy %A Finke, Juergen %A Becher, Burkhard %A Vago, Luca %A Zeiser, Robert %T Phase II trial of hypomethylating agent combined with nivolumab for acute myeloid leukaemia relapse after allogeneic haematopoietic cell transplantation-Immune signature correlates with response. %J British journal of haematology %V 203 %N 2 %@ 0007-1048 %C Oxford [u.a.] %I Wiley-Blackwell %M DKFZ-2023-01580 %P 264-281 %D 2023 %Z 2023 Oct;203(2):264-281 %X Acute myeloid leukaemia (AML) relapse after allogeneic haematopoietic cell transplantation (allo-HCT) is often driven by immune-related mechanisms and associated with poor prognosis. Immune checkpoint inhibitors combined with hypomethylating agents (HMA) may restore or enhance the graft-versus-leukaemia effect. Still, data about using this combination regimen after allo-HCT are limited. We conducted a prospective, phase II, open-label, single-arm study in which we treated patients with haematological AML relapse after allo-HCT with HMA plus the anti-PD-1 antibody nivolumab. The response was correlated with DNA-, RNA- and protein-based single-cell technology assessments to identify biomarkers associated with therapeutic efficacy. Sixteen patients received a median number of 2 (range 1-7) nivolumab applications. The overall response rate (CR/PR) at day 42 was 25 %K acute myeloid leukaemia (Other) %K allogeneic haematopoietic cell transplantation (Other) %K hypomethylating agent (Other) %K immune checkpoint inhibition (Other) %K immune phenotype (Other) %K relapse (Other) %K single-cell RNA-sequencing (Other) %K single-cell immunomonitoring (Other) %F PUB:(DE-HGF)16 %9 Journal Article %$ pmid:37539479 %R 10.1111/bjh.19007 %U https://inrepo02.dkfz.de/record/277924