Trial reportBlood2014
Phase 3 clinical trial of steroids/mycophenolate mofetil vs steroids/placebo as therapy for acute GVHD: BMT CTN 0802.
Trial report in Blood, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01002742 (A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids With Mycophenolate Mofetil vs. Corticosteroids With Placebo as Initial Systemic Treatment of Acute Graft-Vs-Host-Disease), which is not on this map. Cited by 60 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids With Mycophenolate Mofetil vs. Corticosteroids With Placebo as Initial Systemic Treatment of Acute Graft-Vs-Host-Disease (BMT CTN #0802)
Who cites it
60 citing papers in PubMed, 1 synthesis or guideline pooled it, 114 citations in OpenAlex.
- Steroids Versus Steroids Plus Additional Agent in Frontline Treatment of Acute Graft-versus-Host Disease: A Systematic Review and Meta-Analysis of Randomized Trials.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2016Pooled it
- Ruxolitinib plus steroids for acute graft versus host disease: a multicenter, randomized, phase 3 trial.Signal transduction and targeted therapy · 2024Trial
- Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial.BMC medicine · 2024Trial
- A prospective phase 2 clinical trial of a C5a complement inhibitor for acute GVHD with lower GI tract involvement.Bone marrow transplantation · 2023Trial
- Randomized phase II trial of extracorporeal phototherapy and steroids vs. steroids alone for newly diagnosed acute GVHD.Bone marrow transplantation · 2021Trial
- Phase II trial of natalizumab with corticosteroids as initial treatment of gastrointestinal acute graft-versus-host disease.Bone marrow transplantation · 2021Trial
- Biomarker-guided preemption of steroid-refractory graft-versus-host disease with α-1-antitrypsin.Blood advances · 2020Trial
- Analysis of the Whole CDR3 T Cell Receptor Repertoire after Hematopoietic Stem Cell Transplantation in 2 Clinical Cohorts.Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation · 2020Trial
- Trial
- Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation.Bone marrow transplantation · 2019Trial
- Amphiregulin modifies the Minnesota Acute Graft-versus-Host Disease Risk Score: results from BMT CTN 0302/0802.Blood advances · 2018Trial
- Steroid treatment of acute graft-Haematologica · 2017Trial
- The use of basiliximab-infliximab combination for the treatment of severe gastrointestinal acute GvHD.Bone marrow transplantation · 2016Trial
- Biomarker profiling of steroid-resistant acute GVHD in patients after infusion of mesenchymal stromal cells.Leukemia · 2015Trial
- Clinical outcomes of third-line therapy for aGvHD with gastrointestinal involvement after steroids and ruxolitinib failure.Bone marrow transplantation · 2026Article
- Performance of Treatment Response Assessment at Day 7 by Baseline Acute Graft-versus-Host Disease Severity.Transplantation and cellular therapy · 2026Article
- Intestinal epithelial Ceacam1 deficiency prevents steroid-refractory acute gut graft-versus-host disease.JCI insight · 2025Article
- Review
- DHODH inhibition alters T cell metabolism limiting acute graft-versus-host disease while retaining graft-versus-leukemia response.Journal of immunology (Baltimore, Md. : 1950) · 2025Article
- Recent advances in acute gastrointestinal graft versus host disease (aGvHD): aspects of steroid-resistant disease.Annals of hematology · 2025Review
Corrections and comments
- Commented on by
Authors and funding
19 authors at 11 institutions in 1 country.
Funding
Abstract
Corticosteroids are the accepted primary therapy for acute graft-versus-host disease (GVHD), but durable responses are seen in only about half of the patients. Blood and Marrow Transplant Clinical Trials Network (BMT CTN) 0802, a phase 3 multicenter randomized double-blinded trial, was designed to test whether mycophenolate mofetil (MMF) plus corticosteroids was superior to corticosteroids alone as initial therapy for acute GVHD. Patients with newly diagnosed acute GVHD were eligible if they required systemic therapy. Patients were randomized to receive prednisone with either MMF or placebo. The primary end point was acute or chronic GVHD-free survival at day 56 after initiation of therapy. A futility rule for GVHD-free survival at day 56 was met at a planned interim analysis after 235 patients (of 372) were enrolled: 116 MMF, 119 placebo. Baseline characteristics were well balanced between treatment groups including grade and organ distribution of GVHD. GVHD-free survival at day 56, cumulative incidence of chronic GVHD at 12 months, overall survival, Epstein-Barr virus reactivation, severe, life-threatening infections, relapse at 12 months, and quality of life were similar. The addition of MMF to corticosteroids as initial therapy for acute GVHD does not improve GVHD-free survival compared with corticosteroids alone. This trial was registered at www.clinicaltrials.gov as #NCT01002742.
Indexed as
Identifiers
What OpenQuestion holds
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.