Trial reportBlood2020
Randomized multicenter trial of sirolimus vs prednisone as initial therapy for standard-risk acute GVHD: the BMT CTN 1501 trial.
Trial report in Blood, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02806947 (A Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease), which is not on this map. Cited by 51 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 Randomized, Phase II, Multicenter, Open Label, Study Evaluating Sirolimus and Prednisone in Patients With Refined Minnesota Standard Risk, Ann Arbor 1/2 Confirmed Acute Graft-Versus-Host Disease (BMT CTN 1501)
Who cites it
51 citing papers in PubMed, 1 synthesis or guideline pooled it, 82 citations in OpenAlex.
- Cell Therapy Transplant Canada (CTTC) Consensus-Based Guideline 2024 for Management and Treatment of Chronic Graft-Versus-Host Disease and Future Directions for Development.Current oncology (Toronto, Ont.) · 2024Guideline
- Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial.BMC medicine · 2024Trial
- A biomarker signature to predict complete response to itacitinib and corticosteroids in acute graft-versus-host disease.British journal of haematology · 2022Trial
- A phase 2 trial of GVHD prophylaxis with PTCy, sirolimus, and MMF after peripheral blood haploidentical transplantation.Blood advances · 2021Trial
- Biomarker-guided preemption of steroid-refractory graft-versus-host disease with α-1-antitrypsin.Blood advances · 2020Trial
- A phase 1 trial of itacitinib, a selective JAK1 inhibitor, in patients with acute graft-versus-host disease.Blood advances · 2020Trial
- Biomarker-driven strategies and challenges in acute graft-versus-host disease clinical trials.International journal of hematology · 2026Review
- The intestinal microbiota as a key modulator of acute graft-versus-host disease.Nature reviews. Cancer · 2026Review
- Mammalian target of rapamycin inhibitors as the treatment for steroid-refractory acute graft-vs.-host disease after allogeneic hematopoietic stem cell transplantation: A systematic review and individual patient data meta-analysis.Experimental and therapeutic medicine · 2026Article
- Performance of Treatment Response Assessment at Day 7 by Baseline Acute Graft-versus-Host Disease Severity.Transplantation and cellular therapy · 2026Article
- Refinement of day 28 treatment response criteria for acute GVHD: a collaboration study of the JSTCT and MAGIC.Blood advances · 2025Article
- Prediction and Prognostication of Acute Graft-Versus-Host Disease by MAGIC Biomarkers.American journal of hematology · 2025Review
- Pediatric Transplant and Cellular Therapy Consortium RESILIENT Conference on Pediatric Chronic Graft-versus-Host Disease Survivorship after Hematopoietic Cell Transplantation: Part III. Long-Term Impact of Chronic Graft-versus-Host Disease on Endocrinologic, Cardiovascular, and Metabolic Outcomes in Survivors of Pediatric Hematopoietic Cell Transplantation.Transplantation and cellular therapy · 2025Article
- Recent advances in acute gastrointestinal graft versus host disease (aGvHD): aspects of steroid-resistant disease.Annals of hematology · 2025Review
- Age-enhanced MAGIC algorithm predicts mortality in pediatric aGVHD: a multicenter study.Frontiers in immunology · 2025Article
- Graft-Versus-Host Disease Mouse Models: A Clinical-Translational Perspective.Methods in molecular biology (Clifton, N.J.) · 2025Review
- Representativeness of Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Trial Participants.Transplantation and cellular therapy · 2025Article
- Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease.Current hematologic malignancy reports · 2024Review
- mTOR inhibitors potentially preserve fertility in female patients with haematopoietic malignancies: a narrative review.Annals of hematology · 2024Review
- Gastrointestinal involvement refines prognosis in minnesota standard risk acute graft-vs.-host disease.Bone marrow transplantation · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
22 authors at 13 institutions in 1 country.
Funding
Abstract
Clinical- and biomarker-based tools may identify a lower-risk acute graft-versus-host disease (GVHD) population amenable to novel, reduced-intensity treatments. Previous data suggest sirolimus may rival standard of care prednisone. We conducted a National Heart, Lung, and Blood Institute/National Cancer Institute-funded Blood and Marrow Transplant Clinical Trials Network multicenter, open-label, randomized phase 2 trial to estimate the difference in day 28 complete response (CR)/partial response (PR) rates for sirolimus vs prednisone as initial treatment of patients with standard risk (SR) acute GVHD as defined by the Minnesota (MN) GVHD Risk Score and Ann Arbor (AA1/2) biomarker status. A total of 127 MN-SR patients were randomized (1:1), and 122 were AA1/2 (sirolimus, n = 58; prednisone, n = 64). Others were AA3 (n = 4), or AA status missing (n = 1). The day 28 CR/PR rates were similar for sirolimus 64.8% (90% confidence interval [CI], 54.1%-75.5%) vs 73% (90% CI, 63.8%-82.2%) for prednisone. The day 28 rate of CR/PR with prednisone ≤0.25 mg/kg/day was significantly higher for sirolimus than prednisone (66.7% vs 31.7%; P < .001). No differences were detected in steroid-refractory acute GVHD, disease-free survival, relapse, nonrelapse mortality, or overall survival. Sirolimus was associated with reduced steroid exposure and hyperglycemia, reduced grade 2 to 3 infections, improvement in immune suppression discontinuation and patient-reported quality of life, and increased risk for thrombotic microangiopathy. For patients with clinical- and biomarker-based SR acute GVHD, sirolimus demonstrates similar overall initial treatment efficacy as prednisone. In addition, sirolimus therapy spares steroid exposure and allied toxicity, does not compromise long-term survival outcomes, and is associated with improved patient-reported quality of life. This trial was registered at www.clinicaltrials.gov as #NCT02806947.
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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.