The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis

The impact of early tacrolimus (TAC) blood levels on acute graft-versus-host disease (aGVHD) and transplant outcomes in adults undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with posttransplant cyclophosphamide (PTCy) is incompletely investigated. We retrospectively a...

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Main Authors: Alexander Nikoloudis, Veronika Buxhofer-Ausch, Ameya Kunte, Christina Groiss, Lorenz Mair, Christoph Aichinger, Michaela Binder, Petra Hasengruber, Emine Kaynak, Dagmar Wipplinger, Robert Milanov, Irene Strassl, Olga Stiefel, Sigrid Machherndl-Spandl, Holger Rumpold, Ansgar Weltermann, Andreas Petzer, Johannes Clausen
Format: Article
Language:English
Published: SAGE Publishing 2025-08-01
Series:Cell Transplantation
Online Access:https://doi.org/10.1177/09636897251366368
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author Alexander Nikoloudis
Veronika Buxhofer-Ausch
Ameya Kunte
Christina Groiss
Lorenz Mair
Christoph Aichinger
Michaela Binder
Petra Hasengruber
Emine Kaynak
Dagmar Wipplinger
Robert Milanov
Irene Strassl
Olga Stiefel
Sigrid Machherndl-Spandl
Holger Rumpold
Ansgar Weltermann
Andreas Petzer
Johannes Clausen
author_facet Alexander Nikoloudis
Veronika Buxhofer-Ausch
Ameya Kunte
Christina Groiss
Lorenz Mair
Christoph Aichinger
Michaela Binder
Petra Hasengruber
Emine Kaynak
Dagmar Wipplinger
Robert Milanov
Irene Strassl
Olga Stiefel
Sigrid Machherndl-Spandl
Holger Rumpold
Ansgar Weltermann
Andreas Petzer
Johannes Clausen
author_sort Alexander Nikoloudis
collection DOAJ
description The impact of early tacrolimus (TAC) blood levels on acute graft-versus-host disease (aGVHD) and transplant outcomes in adults undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with posttransplant cyclophosphamide (PTCy) is incompletely investigated. We retrospectively analyzed 161 T-cell–replete haplo-HSCT with PTCy, TAC, and mycophenolate-mofetil. TAC trough levels from weeks 1–2 (w1/2) and weeks 3–4 (w3/4) posttransplant were categorized as “Low” or “High” using a threshold of 10 ng/ml. Outcomes assessed included grade III–IV acute graft-versus-host-disease (aGVHD), nonrelapse mortality (NRM), relapse, and overall survival (OS). Multivariate analyses controlled for relevant patient and transplant factors. Higher w1/2 TAC (≥10 ng/ml) in weeks 1–2 had no association with aGVHD III/IV (35% vs. 35%, P = 0.71). Higher TAC levels during w3/4 were associated with a trend toward decreased aGVHD III–IV incidence (8% vs. 20%; P = 0.09). Multivariate analysis confirmed w3/4 TAC levels as protective against aGVHD III/IV (sub-Hazard Ratio [sHR] = 0.83, 95% CI: 0.70–0.98, P = 0.03) and NRM (sHR = 0.82, 95% CI: 0.71–0.95, P = 0.01), while w1/2 TAC levels had no significant impact on the above outcomes. TAC levels did not significantly impact OS or relapse. We conclude that following PTCy-based haplo-HSCT, higher TAC levels during weeks 3–4 may decrease aGVHD and NRM.
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spelling doaj-art-7c24e4e6a59a43b49b20388214a8b99f2025-08-20T03:36:45ZengSAGE PublishingCell Transplantation1555-38922025-08-013410.1177/09636897251366368The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysisAlexander Nikoloudis0Veronika Buxhofer-Ausch1Ameya Kunte2Christina Groiss3Lorenz Mair4Christoph Aichinger5Michaela Binder6Petra Hasengruber7Emine Kaynak8Dagmar Wipplinger9Robert Milanov10Irene Strassl11Olga Stiefel12Sigrid Machherndl-Spandl13Holger Rumpold14Ansgar Weltermann15Andreas Petzer16Johannes Clausen17Faculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaDepartment of Internal Medicine I: Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaFaculty of Medicine, Johannes Kepler University Linz, Linz, AustriaThe impact of early tacrolimus (TAC) blood levels on acute graft-versus-host disease (aGVHD) and transplant outcomes in adults undergoing haploidentical hematopoietic stem cell transplantation (haplo-HSCT) with posttransplant cyclophosphamide (PTCy) is incompletely investigated. We retrospectively analyzed 161 T-cell–replete haplo-HSCT with PTCy, TAC, and mycophenolate-mofetil. TAC trough levels from weeks 1–2 (w1/2) and weeks 3–4 (w3/4) posttransplant were categorized as “Low” or “High” using a threshold of 10 ng/ml. Outcomes assessed included grade III–IV acute graft-versus-host-disease (aGVHD), nonrelapse mortality (NRM), relapse, and overall survival (OS). Multivariate analyses controlled for relevant patient and transplant factors. Higher w1/2 TAC (≥10 ng/ml) in weeks 1–2 had no association with aGVHD III/IV (35% vs. 35%, P = 0.71). Higher TAC levels during w3/4 were associated with a trend toward decreased aGVHD III–IV incidence (8% vs. 20%; P = 0.09). Multivariate analysis confirmed w3/4 TAC levels as protective against aGVHD III/IV (sub-Hazard Ratio [sHR] = 0.83, 95% CI: 0.70–0.98, P = 0.03) and NRM (sHR = 0.82, 95% CI: 0.71–0.95, P = 0.01), while w1/2 TAC levels had no significant impact on the above outcomes. TAC levels did not significantly impact OS or relapse. We conclude that following PTCy-based haplo-HSCT, higher TAC levels during weeks 3–4 may decrease aGVHD and NRM.https://doi.org/10.1177/09636897251366368
spellingShingle Alexander Nikoloudis
Veronika Buxhofer-Ausch
Ameya Kunte
Christina Groiss
Lorenz Mair
Christoph Aichinger
Michaela Binder
Petra Hasengruber
Emine Kaynak
Dagmar Wipplinger
Robert Milanov
Irene Strassl
Olga Stiefel
Sigrid Machherndl-Spandl
Holger Rumpold
Ansgar Weltermann
Andreas Petzer
Johannes Clausen
The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
Cell Transplantation
title The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
title_full The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
title_fullStr The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
title_full_unstemmed The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
title_short The impact of tacrolimus levels on acute GVHD and transplant outcomes in haploidentical hematopoietic stem cell transplantation: A retrospective analysis
title_sort impact of tacrolimus levels on acute gvhd and transplant outcomes in haploidentical hematopoietic stem cell transplantation a retrospective analysis
url https://doi.org/10.1177/09636897251366368
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