Evidence map›Paper›PMID 31401973›Full record

Trial reportBMC medicine2019

Two dose levels of rabbit antithymocyte globulin as graft-versus-host disease prophylaxis in haploidentical stem cell transplantation: a multicenter randomized study.

Ren Lin, Yu Wang, Fen Huang, Zhiping Fan, Shen Zhang, Ting Yang, Yajing Xu, Na Xu, Li Xuan, Jieyu Ye and 3 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC medicine, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01883180 (Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis), which is not on this map. Cited by 49 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 2 pooled it
7.0field-weighted citation impact, top 2% 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.

NCT01883180 phase4completednot on this map

Dose Study of Antithymocyteglobulin in Haploidentical Hematopoietic Stem Cell Transplantation for Acute Graft-versus-host Disease Prophylaxis

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2013 to 2018Enrolled412ConditionsHematopoietic Stem Cell Transplantation, Antithymocyte Globulin, Viral InfectionArmsATG
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 2 syntheses or guidelines pooled it, 77 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

13 authors at 6 institutions in 1 country.

Ren LinDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yu WangDepartment of Hematology, Peking University People's Hospital, Peking University Institute of Hematology, Beijing, China.
Fen HuangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Zhiping FanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Shen ZhangDepartment of Hematology, Peking University People's Hospital, Peking University Institute of Hematology, Beijing, China.
Ting YangDepartment of Hematology, Fujian Institute of Hematology, Fujian Medical University Union Hospital, Fuzhou, China.
Yajing XuDepartment of Hematology, Xiangya Hospital, Central South University, Changsha, China.
Na XuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Li XuanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jieyu YeDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jing SunDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xiaojun HuangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. huangxiaojun@bjmu.edu.cn.
Qifa LiuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. liuqifa628@163.com.
Southern Medical University · CNNanfang Hospital · CNPeking University · CNFujian Medical University · CNPeking University People's Hospital · CNXiangya Hospital Central South University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe optimal dose of rabbit antithymocyte globulin (ATG, ImtixSangstat) minimizing infections without increasing graft-versus-host disease (GVHD) is unknown in T cell-replete, G-CSF-primed haploidentical hematopoietic stem cell transplantation (haplo-HSCT).

methodsFour hundred and eight patients were enrolled in this multicenter study to evaluate the effect of 7.5 mg/kg and 10.0 mg/kg rabbit ATG on viral infections and GVHD prophylaxis after haplo-HSCT. The primary endpoint was EBV DNAemia within 1 year posttransplantation.

resultsThe 1-year incidence of EBV DNAemia was 20.7% (95% confidence interval, 15.4-26.5) and 40.0% (33.3-46.6) in the 7.5 mg/kg and 10.0 mg/kg groups, respectively (P < 0.001). The 100-day cumulative incidence of grade II to IV aGVHD was 27.1% (21.1-33.4) and 25.4% (19.6-31.5) in the 7.5 mg/kg and 10.0 mg/kg ATG groups, respectively (P = 0.548). The 2-year incidence of chronic GVHD was 34.6% (27.8-41.4) and 36.2% (29.1-43.2) in the 7.5 mg and 10.0 mg groups (P = 0.814). The 1-year incidence of CMV DNAemia was 73.4% (67.2-79.4) and 83.4% (77.5-87.9) in the 7.5 mg/kg and 10.0 mg/kg groups (P = 0.038). The 3-year overall survival posttransplantation was 69.5% (63.2-75.8) and 63.5% (56.2-70.8), and the disease-free survival was 62.2% (55.3-69.1) and 60.3% (53.0-67.6) in the 7.5 mg/kg and 10.0 mg/kg groups, respectively (OS: P = 0.308; DFS: P = 0.660). The counts of EBV- and CMV-specific cytotoxic T cells (CTLs) were higher in the 7.5 mg/kg group than in the 10.0 mg/kg group early posttransplantation.

conclusionsCompared with 10.0 mg/kg, 7.5 mg/kg ATG for GVHD prophylaxis was associated with reduced EBV and CMV infections without increased incidence of GVHD in haplo-HSCT, probably by affecting EBV- and CMV-specific CTLs.

trial registrationclinicaltrials.gov, NCT01883180 . Registered 14 June 2013.

Indexed as

AdolescentAdultAntilymphocyte SerumCytomegalovirus InfectionsDisease-Free SurvivalDose-Response Relationship, DrugEpstein-Barr Virus InfectionsFemaleGraft vs Host DiseaseHematopoietic Stem Cell TransplantationHumansImmunosuppressive AgentsMaleMiddle AgedPostoperative ComplicationsAntilymphocyte SerumImmunosuppressive AgentsthymoglobulinAntithymocyte globulinCMVEBVGraft-versus-host diseaseHaploidentical hematopoietic stem cell transplantation

Identifiers

PMID31401973
PMCPMC6689871
OpenAlexW2967100498

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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.