Long term results of a prospective multicenter observational study on the use of anti-human T-lymphocyte immunoglobulin (ATLG) in unrelated donor transplantation (ATOS study)

Jürgen Finke; Claudia Schmoor; Francis Ayuk; Justin Hasenkamp; Mareike Verbeek; Eva-Maria Wagner; Harald Biersack; Kerstin Schäfer-Eckart; Dominik Wolf; Gernot Stuhler; Roland Reibke; Christoph Schmid; Martin Kaufmann; Matthias Eder; Hartmut Bertz; Olga Grishina

doi:10.1038/s41409-024-02264-9

Long term results of a prospective multicenter observational study on the use of anti-human T-lymphocyte immunoglobulin (ATLG) in unrelated donor transplantation (ATOS study)

Bone Marrow Transplant. 2024 Mar 16. doi: 10.1038/s41409-024-02264-9. Online ahead of print.

Authors

Jürgen Finke¹, Claudia Schmoor², Francis Ayuk³, Justin Hasenkamp⁴, Mareike Verbeek⁵, Eva-Maria Wagner⁶, Harald Biersack^{7

8}, Kerstin Schäfer-Eckart⁹, Dominik Wolf^{10

11}, Gernot Stuhler^{12

13}, Roland Reibke¹⁴, Christoph Schmid¹⁵, Martin Kaufmann¹⁶, Matthias Eder¹⁷, Hartmut Bertz¹⁸, Olga Grishina²

Affiliations

¹ University Medical Center and Medical Faculty, University of Freiburg, Breisgau, Germany. juergen.finke@uniklinik-freiburg.de.
² Clinical Trials Unit, Medical Center and Faculty of Medicine, University of Freiburg, Breisgau, Germany.
³ University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
⁴ University Medical Center Göttingen, Göttingen, Germany.
⁵ Technical University of Munich, School of Medicine, Klinikum rechts der Isar, Clinic and Policlinic for Internal Medicine III. München, Munich, Germany.
⁶ University Medical Center Mainz, Mainz, Germany.
⁷ Universitätsklinikum Schleswig-Holstein Campus Lübeck, Lübeck, Germany.
⁸ Klinikum Kulmbach, Bavaria, Germany.
⁹ Medical Center Nürnberg Nord, Nürnberg, Germany.
¹⁰ Medical Clinic 3, Universitätsklinikum Bonn, Bonn, Germany.
¹¹ Dpt. Hematology and Oncology, Comprehensive Cancer Center Innsbruck (CCCI), Innsbruck, Austria.
¹² DKD Helios Klinik Wiesbaden, Wiesbaden, Germany.
¹³ Universätsklinikum Würzburg, Würzburg, Germany.
¹⁴ University Medical Center LMU München, Munich, Germany.
¹⁵ Klinikum Augsburg, Augsburg, Germany.
¹⁶ Robert Bosch Krankenhaus Stuttgart, Stuttgart, Germany.
¹⁷ University Medical Center Hannover, Hannover, Germany.
¹⁸ University Medical Center and Medical Faculty, University of Freiburg, Breisgau, Germany.

PMID: 38493275
DOI: 10.1038/s41409-024-02264-9

Abstract

ATOS is a prospective observational study evaluating the outcome of patients receiving anti-human T-lymphocyte immunoglobulin (ATLG) in unrelated donor transplantation. Primary endpoint was severe GvHD and relapse-free survival (SGRFS). GvHD prophylaxis consisted of ATLG and CSA/ MTX or MMF. Outcome was compared to the ATLG arm of our prospective randomized phase III multicenter trial trial (RCT) [1, 2]. 165 patients, median age 54 (18; 77) years, with haematological malignancies with early (45.5%), intermediate (17.6%), and advanced (37.0%) disease were included. ATLG dose differed between centers according to local practise (median total ATLG dose of 46 (IQR 32-60, range 15-91) mg/kg). Median follow-up was 70 months. Estimated probabilities at 5 years follow up were for SGRFS 0.27, OS 0.52, DFS 0.43, NRM 0.23, relapse 0.34, acute GvhD °III/IV 0.13, severe chronic GvHD 0.27. OS rates differed dependent on disease status. An effect of the given ATLG dose could not be separated from potential center effects. Despite higher age and more advanced disease in ATOS, outcome was similar to the ATLG arm of our RCT. This long-term, multicenter, experience in routine clinical practice confirms the GvHD-protective effect of ATLG without compromising relapse and non-relapse mortality rates.Clinical Trial Registry: German clinical trials register DRKS00004581.