Evidence map›Paper›PMID 38664766›Full record

Trial reportBMC medicine2024

Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial.

Yu Wang, Qi-Fa Liu, De-Pei Wu, Zheng-Li Xu, Ting-Ting Han, Yu-Qian Sun, Fen Huang, Zhi-Ping Fan, Na Xu, Feng Chen and 7 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled TrialClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04960644 (A Multi-cohort, Phase Ⅲ Study of Methotrexate Combined Corticosteroid as First-line Therapy in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
5.0field-weighted citation impact, top 4% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT04960644 phase3completednot on this map

A Multi-cohort, Phase Ⅲ Study of Methotrexate Combined Corticosteroid as First-line Therapy in Chinese Patients With Acute Graft vs. Host Disease After Allogeneic Hematopoietic Stem Cell Transplantation

TypeinterventionalSponsorPeking University People's HospitalRan2021 to 2022Enrolled157ConditionsAcute GVH DiseaseArmsMTX, Corticosteroid
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 11 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors at 3 institutions in 1 country.

Yu Wang *Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Qi-Fa Liu *Department of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.
De-Pei WuJiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China.
Zheng-Li XuPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Ting-Ting HanPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Yu-Qian SunPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Fen HuangDepartment of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.
Zhi-Ping FanDepartment of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.
Na XuDepartment of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China.
Feng ChenJiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China.
Ye ZhaoJiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China.
Yuan KongPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Xiao-Dong MoPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Lan-Ping XuPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Xiao-Hui ZhangPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Kai-Yan LiuPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China.
Xiao-Jun HuangPeking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology, Peking University, Beijing, China. huangxiaojun@bjmu.edu.cn.ORCID 0000-0002-2145-6643
Peking University · CNNanfang Hospital · CNSoochow University · CN

Funding

Key Technologies Research and Development Program 2022YFA1103300Key Technologies Research and Development Program 2023YFC2508905National Natural Science Foundation of China 81930004National Natural Science Foundation of China 82070189National Natural Science Foundation of China 82100227National Natural Science Foundation of China 82270227National Natural Science Foundation of China 82293630Peking University Medicine Fund for world's leading discipline or discipline cluster development 71003Y3035
6 · The paper itself

Abstract

backgroundThere is an urgent unmet need for effective initial treatment for acute graft-versus-host disease (aGVHD) adding to the standard first-line therapy with corticosteroids after allogeneic haematopoietic stem cell transplantation (allo-HSCT).

methodsWe performed a multicentre, open-label, randomized, phase 3 study. Eligible patients (aged 15 years or older, had received allo-HSCT for a haematological malignancy, developed aGVHD, and received no previous therapies for aGVHD) were randomly assigned (1:1) to receive either 5 mg/m

resultsThe primary endpoint was the overall response rate (ORR) on Day 10. A total of 157 patients were randomly assigned to receive either MTX plus corticosteroids (n = 78; MTX group) or corticosteroids alone (n = 79; control group). The Day 10 ORR was 97% for the MTX group and 81% for the control group (p = .005). Among patients with mild aGVHD, the Day 10 ORR was 100% for the MTX group and 86% for the control group (p = .001). The 1-year estimated failure-free survival was 69% for the MTX group and 41% for the control group (p = .002). There were no differences in treatment-related adverse events between the two groups.

conclusionsIn conclusion, mini-dose MTX combined with corticosteroids can significantly improve the ORR in patients with aGVHD and is well tolerated, although it did not achieve the prespecified 20% improvement with the addition of MTX.

trial registrationThe trial was registered with clinicaltrials.gov (NCT04960644).

Indexed as

Graft vs Host DiseaseHematopoietic Stem Cell TransplantationMethotrexateMethylprednisoloneAcute DiseaseAdolescentAdultAgedDrug Therapy, CombinationFemaleHumansMaleMiddle AgedTreatment OutcomeYoung AdultMethotrexateMethylprednisoloneAcuteGVHDMethotrexateMini-dose

Identifiers

PMID38664766
PMCPMC11044329
OpenAlexW4395455595

What Socratic holds

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LicenceCC BY
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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 Socratic graph.