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Clinical Trial
. 2024 Jul;59(7):936-941.
doi: 10.1038/s41409-024-02264-9. Epub 2024 Mar 16.

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  1 , Claudia Schmoor  2 , Francis Ayuk  3 , Justin Hasenkamp  4 , Mareike Verbeek  5 , Eva-Maria Wagner  6 , Harald Biersack  7   8 , Kerstin Schäfer-Eckart  9 , Dominik Wolf  10   11 , Gernot Stuhler  12   13 , Roland Reibke  14 , Christoph Schmid  15 , Martin Kaufmann  16 , Matthias Eder  17 , Hartmut Bertz  18 , Olga Grishina  2
Affiliations
Clinical Trial

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 et al. Bone Marrow Transplant. 2024 Jul.

Erratum in

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.

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Conflict of interest statement

JF and HB had received travel and lecture fees from Neovii Biotech, CS and OG have received an institutional research grant from Neovii Biotech.

Figures

Fig. 1
Fig. 1. Probability of OS by disease status.
Estimated probability of overall survival (OS) by disease status - unadjusted and from Cox regression model adjusted for center, type of disease, conditioning intensity, time from primary diagnosis of current disease to transplantation, HLA-mismatch.
Fig. 2
Fig. 2. Probability of SGRFS by HLA-mismatch.
Estimated probability of severe GvHD and relapse-free survival (SGRFS) by HLA-mismatch - unadjusted and from Cox regression model adjusted for center, patient age, patient and donor sex, type of disease, disease status, conditioning regimen.
Fig. 3
Fig. 3. Probability of OS by ATLG-dose.
Probability of overall survival (OS) by ATLG-dose - unadjusted and from Cox regression model adjusted for center, patient age, donor age, CMV status of patient, type of disease, disease status, time from primary diagnosis of current disease to transplantation, HLA-mismatch.
See this image and copyright information in PMC

References

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