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)
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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.
in: BONE MARROW TRANSPL, Jahrgang 59, Nr. 7, 07.2024, S. 936-941.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - 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)
AU - Finke, Jürgen
AU - Schmoor, Claudia
AU - Ayuk, Francis
AU - Hasenkamp, Justin
AU - Verbeek, Mareike
AU - Wagner, Eva-Maria
AU - Biersack, Harald
AU - Schäfer-Eckart, Kerstin
AU - Wolf, Dominik
AU - Stuhler, Gernot
AU - Reibke, Roland
AU - Schmid, Christoph
AU - Kaufmann, Martin
AU - Eder, Matthias
AU - Bertz, Hartmut
AU - Grishina, Olga
N1 - © 2024. The Author(s).
PY - 2024/7
Y1 - 2024/7
N2 - 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.
AB - 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.
KW - Humans
KW - Middle Aged
KW - Adult
KW - Male
KW - Prospective Studies
KW - Female
KW - Unrelated Donors
KW - Aged
KW - Adolescent
KW - Graft vs Host Disease/prevention & control
KW - Hematopoietic Stem Cell Transplantation/methods
KW - Young Adult
KW - Hematologic Neoplasms/therapy
KW - Disease-Free Survival
KW - Follow-Up Studies
KW - T-Lymphocytes/immunology
U2 - 10.1038/s41409-024-02264-9
DO - 10.1038/s41409-024-02264-9
M3 - SCORING: Journal article
C2 - 38493275
VL - 59
SP - 936
EP - 941
JO - BONE MARROW TRANSPL
JF - BONE MARROW TRANSPL
SN - 0268-3369
IS - 7
ER -
