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).

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

doi:10.1038/s41409-024-02264-9

journal article

Titel:: 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).
Dokumenttyp:: Article; Journal Article; Multicenter Study; Observational Study; Randomized Controlled Trial; Clinical Trial, Phase III
Autor(en):: Finke, Jürgen; Schmoor, Claudia; Ayuk, Francis; Hasenkamp, Justin; Verbeek, Mareike; Wagner, Eva-Maria; Biersack, Harald; Schäfer-Eckart, Kerstin; Wolf, Dominik; Stuhler, Gernot; Reibke, Roland; Schmid, Christoph; Kaufmann, Martin; Eder, Matthias; Bertz, Hartmut; Grishina, Olga
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. «
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... »
Zeitschriftentitel:: Bone Marrow Transplant
Jahr:: 2024
Band / Volume:: 59
Heft / Issue:: 7
Seitenangaben Beitrag:: 936-941
Volltext / DOI:: doi:10.1038/s41409-024-02264-9
PubMed:: http://view.ncbi.nlm.nih.gov/pubmed/38493275
Print-ISSN:: 0268-3369
TUM Einrichtung:: Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie (Prof. Bassermann)
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mediaTUM Gesamtbestand Einrichtungen Schools TUM School of Medicine and Health Departments Clinical Medicine Klinik und Poliklinik für Innere Medizin III, Hämatologie und Onkologie (Prof. Bassermann)2024