A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy

Autor: Weissinger, Eva M., Metzger, Jochen, Schleuning, Michael, Schmid, Christoph, Messinger, Diethelm, Beutel, Gernot, Wagner-Drouet, Eva-Maria, Schetelig, Johannes, Baurmann, Herrad, Rank, Andreas, Stolzl, Friedrich, Schäfer-Eckart, Kerstin, Westphal, Karin, Bethge, Wolfgang, von Harsdorf, S., Bunjes, Donald W., Heidenreich, Daniela, Klein, Stefan, Holler, Ernst, Kreipe, Hans H., Jonigk, Danny, Türüchanow, Irina, Raad, Julia, Papkalla, Armin, von der Leyen, Heiko, Hambach, Lothar, Hamwi, Iyas, Ehrlich, Steve, Krauter, Jurgen, Stadler, Michael, Ganser, Arnold
Zdroj: Leukemia; June 2021, Vol. 35 Issue: 6 p1763-1772, 10p
Abstrakt: 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.
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