A multicenter prospective, randomized, placebo-controlled phase II/III trial for preemptive acute graft-versus-host disease therapy.
Acute Disease
Adolescent
Adult
Aged
Anti-Inflammatory Agents
/ therapeutic use
Female
Follow-Up Studies
Graft vs Host Disease
/ drug therapy
Hematologic Neoplasms
/ pathology
Hematopoietic Stem Cell Transplantation
/ adverse effects
Humans
Male
Middle Aged
Prednisolone
/ therapeutic use
Prognosis
Prospective Studies
Proteome
/ analysis
Survival Rate
Transplantation, Homologous
Young Adult
Journal
Leukemia
ISSN: 1476-5551
Titre abrégé: Leukemia
Pays: England
ID NLM: 8704895
Informations de publication
Date de publication:
06 2021
06 2021
Historique:
received:
17
06
2020
accepted:
05
10
2020
revised:
24
08
2020
pubmed:
22
10
2020
medline:
17
8
2021
entrez:
21
10
2020
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 33082512
doi: 10.1038/s41375-020-01059-3
pii: 10.1038/s41375-020-01059-3
pmc: PMC8179847
doi:
Substances chimiques
Anti-Inflammatory Agents
0
Proteome
0
Prednisolone
9PHQ9Y1OLM
Types de publication
Clinical Trial, Phase II
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1763-1772Références
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