Trial reportSignal transduction and targeted therapy2024
Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial.
Trial report in Signal transduction and targeted therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 9 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Ruxolitinib in Combination With Corticosteroid as First Line Therapy for the Treatment of High Risk Acute Graft-Versus-Host Disease
A Prospective, Single-Arm, Phase II Clinical Study of Gecacitinib-Corticosteroids as First-Line Treatment for Grade II-IV Acute Graft-Versus-Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial
Prospective Randomized Controlled Trial of Novel Therapies for Severe Acute GVHD (Graft-versus-host Disease)
Who cites it
9 citing papers in PubMed.
- Biomarker-driven strategies and challenges in acute graft-versus-host disease clinical trials.International journal of hematology · 2026Review
- Low-dose ruxolitinib as first-line therapy for acute graft-versus-host disease (aGVHD) increases the risk of Epstein-Barr virus (EBV) reactivation but not posttransplant lymphoproliferative disease (PTLD).Cancer pathogenesis and therapy · 2026Article
- Loss of SOCS1 in Donor T Cells Exacerbates Intestinal GVHD by Driving a Chemokine-Dependent Pro-Inflammatory Immune Microenvironment.Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026Article
- A phase 1b study on the safety of Wharton's jelly mesenchymal stromal cells in the treatment of acute graft-versus-host disease.Cytotherapy · 2026Article
- Gastrointestinal acute graft versus host disease: a translational perspective from pathogenesis to precision prevention and treatment.Frontiers in immunology · 2026Review
- Xenopax is effective for the treatment and prophylaxis of acute graft-versus-host disease.Blood science (Baltimore, Md.) · 2025Article
- Article
- Efficacy and safety of ruxolitinib combined with steroids for first-line treatment of acute graft-versus-host disease after hematopoietic stem cell transplantation: a single-center, real-world experience.Frontiers in immunology · 2025Article
- Review
Corrections and comments
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Authors and funding
22 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Newly diagnosed patients with high-risk acute graft-versus-host disease (aGVHD) often experience poor clinical outcomes and low complete remission rates. Ruxolitinib with corticosteroids showed promising efficacy in improving response and failure free survival in our phase I study. This study (ClinicalTrials.gov: NCT04061876) sought to evaluate the safety and effectiveness of combining ruxolitinib (RUX, 5 mg/day) with corticosteroids (1 mg/kg/day methylprednisolone, RUX/steroids combined group) versus using methylprednisolone alone (2 mg/kg/day, steroids-only group). Newly diagnosed patients with intermediate- or high-risk aGVHD were included, with risk levels classified by either the Minnesota aGVHD Risk Score or biomarker assessment. Patients were randomized in a ratio of 1:1 into 2 groups: 99 patients received RUX combined with methylprednisolone, while the other 99 received methylprednisolone alone as the initial treatment. The RUX/steroids group showed a significantly higher overall response rate (ORR) on day 28 (92.9%) compared to the steroids-only group (70.7%, Odds Ratio [OR] = 5.8; 95% Confidence Interval [CI], 2.4-14.0; P < 0.001). Similarly, the ORR on day 56 was higher in the RUX/steroids group (85.9% vs. 46.5%; OR = 7.07; 95% CI, 3.36-15.75; P < 0.001). Additionally, the 18-month failure-free survival was significantly better in the RUX/steroids group (57.2%) compared to the steroids-only group (33.3%; Hazard Ratio = 0.46; 95% CI, 0.31-0.68; P < 0.001). Adverse events (AEs) frequencies were comparable between both groups, with the exception of fewer grade 4 AEs in the RUX/steroids group (26.3% vs. 50.5% P = 0.005). To our knowledge, this study is the first prospective, randomized controlled trial to demonstrate that adding ruxolitinib to the standard methylprednisolone regimen provides an effective and safe first-line treatment for newly diagnosed high-risk acute GVHD.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.