Evidence map›Paper›PMID 37120593›Full record

Trial reportJournal of hematology & oncology2023

Venetoclax Combined with Azacitidine and Homoharringtonine in Relapsed/Refractory AML: A Multicenter, Phase 2 Trial.

Hua Jin, Yu Zhang, Sijian Yu, Xin Du, Na Xu, Ruoyang Shao, Dongjun Lin, Yanqiu Chen, Jie Xiao, Zhiqiang Sun and 14 more

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of hematology & oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 2 pooled it
19.2field-weighted citation impact, top 1% 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.

NCT04424147 phase2completednot on this map

Efficacy and Safety of HVA Regimens as Salvage Treatment in Relapsed/Refractory (rr) Acute Myeloid Leukemia (AML)

TypeinterventionalSponsorNanfang Hospital, Southern Medical UniversityRan2020 to 2022Enrolled96ConditionsRefractory Acute Myeloid Leukemia, Relapsed Acute Erythroid Leukemia, Salvage Treatment, HVA RegimenArmsHVA Regimens as Salvage Treatment
NCT06483906 phase2recruitingnot on this mapstarted 2024, after this paper: background citation

Efficacy and Safety of Venetoclax and Azacitidine Combined With Low-Intensity Homoharringtonine Chemotherapy Followed by Allogeneic Hematopoietic Stem Cell Transplantation in Intermediate/High-Risk Newly Diagnosed Acute Myeloid Leukemia

TypeinterventionalSponsorShanghai General Hospital, Shanghai Jiao Tong University School of MedicineRan2024 to 2028Enrolled56ConditionsAcute Myeloid LeukemiaArmsVenetoclax, Azacitidine and Homoharringtonine
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 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

24 authors at 9 institutions in 1 country.

Hua Jin *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Yu Zhang *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Sijian Yu *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xin Du *Department of Hematology and Shenzhen Bone Marrow Transplantation Public Service Platform, Shenzhen Second People's Hospital, The First Affiliated Hospital of Shenzhen University, Shenzhen, China.
Na Xu *Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Ruoyang ShaoDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Dongjun LinDepartment of Hematology, The Seventh Affiliated Hospital of Sun Yat-Sen University, Shenzhen, China.
Yanqiu ChenDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Jie XiaoDepartment of Hematology, Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China.
Zhiqiang SunDepartment of Hematology, Shenzhen Hospital, Southern Medical University, Shenzhen, China.
Lan DengDepartment of Hematology, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Xinquan LiangDepartment of Hematology, The First People's Hospital of Chenzhou, Chenzhou, China.
Hongyu ZhangDepartment of Hematology, Peking University Shenzhen Hospital, Shenzhen, China.
Ziwen GuoDepartment of Hematology, Zhongshan City People's Hospital, Zhongshan, China.
Min DaiDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Pengcheng ShiDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Fen HuangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Zhiping FanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Zhao YinDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Li XuanDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Ren LinDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Xuejie JiangDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
Guopan YuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. yugpp@163.com.
Qifa LiuDepartment of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, China. liuqifa628@163.com.
Southern Medical University · CNNanfang Hospital · CNSun Yat-sen University · CNChenzhou First People's Hospital · CNPeking University Shenzhen Hospital · CNShanghai Jiao Tong University · CNShenzhen Second People's Hospital · CNSouthern Medical University Shenzhen Hospital · CNZhongshan People's Hospital · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRelapsed or refractory acute myeloid leukemia (R/R AML) has a dismal prognosis. The aim of this study was to investigate the activity and tolerability of venetoclax combined with azacitidine plus homoharringtonine (VAH) regimen for R/R AML.

methodsThis phase 2 trial was done at ten hospitals in China. Eligible patients were R/R AML (aged 18-65 years) with an Eastern Cooperative Oncology Group performance status of 0-2. Patients received venetoclax (100 mg on day 1, 200 mg on day 2, and 400 mg on days 3-14) and azacitidine (75 mg/m

resultsBetween May 27, 2020, and June 16, 2021, we enrolled 96 patients with R/R AML, including 37 primary refractory AML and 59 relapsed AML (16 relapsed after chemotherapy and 43 after allo-HSCT). The CRc rate was 70.8% (95% CI 60.8-79.2). In the patients with CRc, measurable residual disease (MRD)-negative was attained in 58.8% of CRc patients. Accordingly, overall response rate (ORR, CRc plus partial remission (PR)) was 78.1% (95% CI 68.6-85.4). At a median follow-up of 14.7 months (95% CI 6.6-22.8) for all patients, median overall survival (OS) was 22.1 months (95% CI 12.7-Not estimated), and event-free survival (EFS) was 14.3 months (95% CI 7.0-Not estimated). The 1-year OS was 61.5% (95% CI 51.0-70.4), and EFS was 51.0% (95% CI 40.7-60.5). The most common grade 3-4 adverse events were febrile neutropenia (37.4%), sepsis (11.4%), and pneumonia (21.9%).

conclusionsVAH is a promising and well-tolerated regimen in R/R AML, with high CRc and encouraging survival. Further randomized studies are needed to be explored. Trial registration clinicaltrials.gov identifier: NCT04424147.

Indexed as

AzacitidineLeukemia, Myeloid, AcuteAntineoplastic Combined Chemotherapy ProtocolsBridged Bicyclo Compounds, HeterocyclicHomoharringtonineHumansSulfonamidesAzacitidineBridged Bicyclo Compounds, HeterocyclicHomoharringtonineSulfonamidesvenetoclaxAcute myeloid leukemiaAzacitidineHomoharringtonineRefractoryRelapsedVenetoclax

Identifiers

PMID37120593
PMCPMC10149010
OpenAlexW4367394974

What OpenQuestion holds

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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.