دورية أكاديمية
أعرض في EDS

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

التفاصيل البيبلوغرافية
العنوان: Mini-dose methotrexate combined with methylprednisolone for the initial treatment of acute GVHD: a multicentre, randomized trial.
المؤلفون: Wang Y; 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., Liu QF; Department of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China., Wu DP; Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China., Xu ZL; 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., Han TT; 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., Sun YQ; 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.; Department of Hematology, Beijing Ludaopei Hematology Hospital, Beijing, China., Huang F; Department of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China., Fan ZP; Department of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China., Xu N; Department of Hematology, Nanfang Hospital Affiliated to Southern Medical University, Guangzhou, China., Chen F; Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China., Zhao Y; Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Soochow, China., Kong Y; 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., Mo XD; 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., Xu LP; 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., Zhang XH; 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., Liu KY; 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.; Department of Hematology, Beijing Ludaopei Hematology Hospital, Beijing, China., Huang XJ; 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. huangxiaojun@bjmu.edu.cn.; Peking-Tsinghua Center for Life Sciences, Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, China. huangxiaojun@bjmu.edu.cn.; State Key Laboratory of Natural and Biomimetic Drugs, Peking University, Beijing, China. huangxiaojun@bjmu.edu.cn.
المصدر: BMC medicine [BMC Med] 2024 Apr 25; Vol. 22 (1), pp. 176. Date of Electronic Publication: 2024 Apr 25.
نوع المنشور: Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't; Clinical Trial, Phase III
اللغة: English
بيانات الدورية: Publisher: BioMed Central Country of Publication: England NLM ID: 101190723 Publication Model: Electronic Cited Medium: Internet ISSN: 1741-7015 (Electronic) Linking ISSN: 17417015 NLM ISO Abbreviation: BMC Med Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BioMed Central, 2003-
مواضيع طبية MeSH: Graft vs Host Disease*/drug therapy , Methotrexate*/administration & dosage , Methotrexate*/therapeutic use , Methylprednisolone*/therapeutic use , Methylprednisolone*/administration & dosage , Hematopoietic Stem Cell Transplantation*/adverse effects, Humans ; Female ; Male ; Middle Aged ; Adult ; Young Adult ; Treatment Outcome ; Drug Therapy, Combination ; Aged ; Adolescent ; Acute Disease
مستخلص: Background: There 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).
Methods: We 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 2 MTX on Days 1, 3, or 8 and then combined with corticosteroids or corticosteroids alone weekly.
Results: The 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.
Conclusions: In 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 Registration: The trial was registered with clinicaltrials.gov (NCT04960644).
(© 2024. The Author(s).)
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معلومات مُعتمدة: 82270227 National Natural Science Foundation of China; 82070189 National Natural Science Foundation of China; 82100227 National Natural Science Foundation of China; 82293630 National Natural Science Foundation of China; 81930004 National Natural Science Foundation of China; 2023YFC2508905 Key Technologies Research and Development Program; 2022YFA1103300 Key Technologies Research and Development Program; 71003Y3035 Peking University Medicine Fund for world's leading discipline or discipline cluster development
فهرسة مساهمة: Keywords: Acute; GVHD; Methotrexate; Mini-dose
سلسلة جزيئية: ClinicalTrials.gov NCT04960644
المشرفين على المادة: YL5FZ2Y5U1 (Methotrexate)
X4W7ZR7023 (Methylprednisolone)
تواريخ الأحداث: Date Created: 20240425 Date Completed: 20240426 Latest Revision: 20240509
رمز التحديث: 20240509
مُعرف محوري في PubMed: PMC11044329
DOI: 10.1186/s12916-024-03395-y
PMID: 38664766
قاعدة البيانات: MEDLINE
الوصف
تدمد:1741-7015
DOI:10.1186/s12916-024-03395-y