Evidence map›Paper›PMID 41084078›Full record

Trial reportClinical epigenetics2025

Phase II study of dual epigenetic targeting with chidamide and azacitidine in patients with high-risk acute myeloid leukemia after allo-HSCT.

Ya-Xue Wu, Chao-Ling Wan, Kai-Wen Tan, Yang Zhang, Yan-Ming Zhang, Hao Zhang, De-Pei Wu, Su-Ning Chen, Ying Wang, Xiao Ma and 7 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical epigenetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
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.

Ya-Xue Wu *Soochow Hopes Hematology Hospital, Suzhou, China.
Chao-Ling Wan *The First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Kai-Wen Tan *The First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Yang Zhang *Canglang Hospital of Suzhou, Suzhou, China.
Yan-Ming Zhang *Huai'an Second People's Hospital, Huai'an, China.
Hao ZhangAffiliated Hospital of Jining Medical University, Jining, China.
De-Pei WuThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Su-Ning ChenThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Ying WangThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Xiao MaThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Hai-Ping DaiThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Chong-Sheng QianThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Shan-Shan JiangSoochow Hopes Hematology Hospital, Suzhou, China.
Hai-Yan BaoThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China.
Xiao-Hui HuThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China. hxh27@163.com.
Zheng LiThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China. lzheng@suda.edu.cn.
Sheng-Li XueThe First Affiliated Hospital of Soochow University, Suzhou, 215000, China. slxue@suda.edu.cn.

Funding

Boxi Leading Talent Program Grant No. 02622Innovative and Applied Scientific Research Project of Professional Ability of Clinical Specialists (RCLX2315016);the National Key R&D Program of China 2022YFC2502703Jiangsu Province "333" Project, Boxi Clinical Research Project Grant No. BXLC008Jiangsu Province Natural Science Foundation of China No. BK20221235National Natural Science Foundation of China Nos. 82470224,82270165Su Zhou Industrial Park He He Yuan Da Blood Innovation Research Institute H221084
6 · The paper itself

Abstract

backgroundAllogeneic hematopoietic stem cell transplantation (allo-HSCT) is potentially the only curative option for high-risk acute myeloid leukemia (AML) patients. However, disease relapse remains the principal cause of treatment failure of these patients, and outcomes of salvage treatments are poor. This research seeks to evaluate the efficacy and safety of a dual epigenetic targeting maintenance therapy with chidamide and azacitidine (AZA) in patients with high-risk AML post-allo-HSCT.

methodsThis multicenter, open-label, phase 2 prospective clinical trial (ChiCTR2300067593) recruited and followed up 48 patients diagnosed with high-risk AML post-allo-HSCT from 3 hospitals in China from November 2021 to March 2024. Chidamide (5 mg) was administered orally once daily for 5 days, combined with AZA (75 mg/m

resultsThe 2-year cumulative incidence of relapse (CIR) was 8.4% (95% CI 4.4-12.4%), 2-year relapse-free survival (RFS) was 91.6% (95% CI 87.6-95.6%), and overall survival (OS) was 97.9% (95% CI 95.8-100%). At the end of the follow-up period, 4 patients relapsed, of which 1 patient died of leukemia recurrence; the other three patients underwent second allo-HSCT and are still alive in remission. The most common adverse events (AEs) were hematological toxicity. No grade > 3 AEs were noted. Graft-versus-host disease (GVHD) occurred in 29.2% (14/48) of patients. Six cases (6/48, 12.5%) were complicated with infection. No treatment-related mortality occurred.

conclusionsDual epigenetic targeting maintenance treatment with CHI-AZA has an acceptable toxicity profile and might potentially be effective to prevent relapse in high-risk AML patients after allo-HSCT.

trial registrationClinicalTrials.gov, ChiCTR2300067593. Registered January 12, 2013.

Indexed as

AminopyridinesAzacitidineBenzamidesEpigenesis, GeneticHematopoietic Stem Cell TransplantationLeukemia, Myeloid, AcuteAdolescentAdultAgedChinaFemaleHumansMaleMiddle AgedProspective StudiesTransplantation, HomologousAminopyridinesAzacitidineBenzamidesN-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamideAcute myeloid leukemiaAllogeneic hematopoietic stem cell transplantationAzacytidineChidamideMaintenance therapy

Identifiers

PMID41084078
PMCPMC12519874

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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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.