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Mischak-Weissinger, Eva Maria
[Verfasser:in];
Metzger, Jochen
[Verfasser:in];
Schleuning, Michael
[Verfasser:in];
Schmid, Christoph
[Verfasser:in];
Messinger, Diethelm
[Verfasser:in];
Beutel, Gernot
[Verfasser:in];
Wagner-Drouet, Eva-Maria
[Verfasser:in];
Schetelig, Johannes
[Verfasser:in];
Baurmann, Herrad
[Verfasser:in];
Rank, Andreas
[Verfasser:in];
Stolzl, Friedrich
[Verfasser:in];
Schäfer-Eckart, Kerstin
[Verfasser:in];
Westphal, Karin
[Verfasser:in];
Bethge, Wolfgang
[Verfasser:in];
Harsdorf, S. von
[Verfasser:in];
Bunjes, Donald W.
[Verfasser:in];
Heidenreich, Daniela
[Verfasser:in];
Klein, Stefan
[Verfasser:in];
Holler, Ernst
[Verfasser:in];
Kreipe, Hans H.
[Verfasser:in];
Jonigk, Danny
[Verfasser:in];
Türüchanow, Irina
[Verfasser:in];
Raad, Julia
[Verfasser:in];
Papkalla, Armin
[Verfasser:in];
[...]
A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy
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- Medientyp: E-Artikel
- Titel: A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy
- Beteiligte: Mischak-Weissinger, Eva Maria [Verfasser:in]; Metzger, Jochen [Verfasser:in]; Schleuning, Michael [Verfasser:in]; Schmid, Christoph [Verfasser:in]; Messinger, Diethelm [Verfasser:in]; Beutel, Gernot [Verfasser:in]; Wagner-Drouet, Eva-Maria [Verfasser:in]; Schetelig, Johannes [Verfasser:in]; Baurmann, Herrad [Verfasser:in]; Rank, Andreas [Verfasser:in]; Stolzl, Friedrich [Verfasser:in]; Schäfer-Eckart, Kerstin [Verfasser:in]; Westphal, Karin [Verfasser:in]; Bethge, Wolfgang [Verfasser:in]; Harsdorf, S. von [Verfasser:in]; Bunjes, Donald W. [Verfasser:in]; Heidenreich, Daniela [Verfasser:in]; Klein, Stefan [Verfasser:in]; Holler, Ernst [Verfasser:in]; Kreipe, Hans H. [Verfasser:in]; Jonigk, Danny [Verfasser:in]; Türüchanow, Irina [Verfasser:in]; Raad, Julia [Verfasser:in]; Papkalla, Armin [Verfasser:in]; von der Leyen, Heiko [Verfasser:in]; Hambach, Lothar [Verfasser:in]; Hamwi, Iyas [Verfasser:in]; Ehrlich, Steve [Verfasser:in]; Krauter, Jurgen [Verfasser:in]; Stadler, Michael [Verfasser:in]; Ganser, Arnold [Verfasser:in]
-
Erschienen:
2021
- Erschienen in: Leukemia ; 35(2021), 6, Seite 1763-1772
- Sprache: Englisch
- DOI: 10.1038/s41375-020-01059-3
- Identifikator:
- Schlagwörter: Clinical trials ; Translational research
- Entstehung:
-
Anmerkungen:
"Published online: 20 October 2020".- S. 1763
- Beschreibung: Acute graft-versus-host disease (aGvHD) contributes to about 50% of transplant-related mortality (non-relapse mortality) after allogeneic hematopoietic stem cell transplantation (HSCT). Here the predictive value of a urinary proteomic profile (aGvHD_MS17) was tested together with preemptive prednisolone therapy. Two-hundred and fifty-nine of 267 patients were eligible for analysis. Ninety-two patients were randomized upon aGvHD_MS17 classification factor above 0.1 to receive either prednisolone (2-2.5 mg/kg, N = 44) or placebo (N = 47; N = 1 randomization failure) for 5 days followed by tapering. The remaining 167 patients formed the observation group. The primary endpoint of the randomized trial was incidence of aGvHD grade II between randomization and day +100 post HSCT. Analysis of the short-term preemptive prednisolone therapy in the randomized patients showed no significant difference in incidence or severity of acute GvHD (HR: 1.69, 95% CI: 0.66-4.32, P = 0.27). Prednisolone as preemptive treatment did not lead to an increase in relapse (20.2% in the placebo and 14.0% in the prednisolone group (P = 0.46)). The frequency of adverse events was slightly higher in the placebo group (64.4% versus 50%, respectively). Taken together, the results of the Pre-GvHD trial demonstrated the feasibility and safety of preemptive prednisolone treatment in the randomized patients.
- Zugangsstatus: Freier Zugang