Evidence map›Paper›PMID 39748491›Full record

Trial reportCancer2025

Liposomal mitoxantrone monotherapy in patients with relapsed or refractory mature T-cell and natural killer-cell neoplasms: A phase 2, multicenter, open-label, single-arm trial.

Yan Gao, Yunhong Huang, Qingyuan Zhang, Haiyan Yang, Yufu Li, Yan Li, Min Zhou, Runxiang Yang, Bing Xu, Lihong Liu and 21 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03776279 (Single-arm, Open and Multi-center Phase II Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
–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.

NCT03776279 phase2unknown statusnot on this map

Single-arm, Open and Multi-center Phase II Study of Liposome-entrapped Mitoxantrone Hydrochloride Injection in Relapsed/Refractory Peripheral T-cell Lymphoma and NK/T-cell Lymphoma

TypeinterventionalSponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.Ran2018 to 2020Enrolled106ConditionsRelapsed or Refractory Peripheral T-cell and NK/T-cell LymphomaArmsMitoxantrone Hydrochloride Liposome Injection
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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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

31 authors.

Yan GaoState Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.ORCID https://orcid.org/0000-0002-1268-2999
Yunhong HuangThe Affiliated Cancer Hospital of Guizhou Medical University, Guiyang, China.
Qingyuan ZhangHarbin Medical University Cancer Hospital, Harbin, China.
Haiyan YangZhejiang Cancer Hospital, Hangzhou, China.
Yufu LiHenan Tumor Hospital, Zhengzhou, China.
Yan LiThe First Hospital of China Medical University, Shenyang, China.
Min ZhouTumor Hospital affiliated to Guangzhou Medical University, Guangzhou, China.
Runxiang YangYunnan Cancer Hospital, Kunming, China.
Bing XuThe First Affiliated Hospital of Xiamen University, Xiamen, China.
Lihong LiuFourth Hospital of Hebei Medical University, Shijiazhuang, China.
Yu YangFujian Provincial Cancer Hospital, Fuzhou, China.
Zhigang PengFirst Affiliated Hospital of Guangxi Medical University, Nanning, China.
Ding YuHubei Cancer Hospital, Wuhan, China.
Hui ZhouHunan Cancer Hospital, Changsha, China.
Rongyan ZhangThe First Affiliated Hospital of Nanchang University, Nanchang, China.
Huilai ZhangTianjin Medical University, Cancer Institute & Hospital, Tianjin, China.
Junyuan QiChinese Academy of Medical Sciences Institute of Hematology and Blood Diseases Hospital, Tianjin, China.
Yaming XiFirst Hospital Affiliated to Lanzhou University, Lanzhou, China.
Xiaojing XingLiaoning Cancer Hospital & Institute, Shenyang, China.
Zhao WangBeijing Friendship Hospital, Capital Medical University, Beijing, China.
Hongmei JingPeking University Third Hospital, Beijing, China.
Yuerong ShuangJiangxi Cancer Hospital, Nanchang, China.
Xiaohong ZhangSecond Hospital Affiliated to Zhejiang University Medical College, Hangzhou, China.
Liping MaSun Yat-sen Memorial Hospital of Sun Yat-sen University, Guangzhou, China.
Hongyan JinWuhan Puren Hospital, Wuhan, China.
Li'e LinHainan General Hospital, Haikou, China.
Chunlei LiCSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Company, Ltd, Shijiazhuang, China.
Jianfei XueCSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Company, Ltd, Shijiazhuang, China.
Yanping LiuCSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Company, Ltd, Shijiazhuang, China.
Jing YuanCSPC ZhongQi Pharmaceutical Technology (Shijiazhuang) Company, Ltd, Shijiazhuang, China.
Huiqiang HuangState Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.

Funding

China's National Key R&D Program 2017YFA0205600CSPC ZhongQi Pharmaceutical Technology Co., Ltd
6 · The paper itself

Abstract

introductionThe prognosis of relapsed or refractory mature T- and natural killer (NK)-cell lymphoma remains dismal. Novel agents are urgently needed to improve the outcomes for this population.

methodsIn this phase 2, multicenter, open-label, single-arm study (NCT03776279), the authors report the efficacy and safety of liposomal mitoxantrone (Lipo-MIT) monotherapy in patients with relapsed or refractory mature T- and NK-cell lymphoma. Lipo-MIT was administered intravenously at 20 mg/m

resultsFrom April 26, 2018, to August 10, 2022, 108 eligible patients were enrolled and treated at 26 study centers in China. The ORRs were 41.7% (95% confidence interval [CI], 32.3-51.5%) per IRC and 46.3% (95% CI, 36.7%-56.2%) per investigators; 25 (23.1%) and 15 (13.9%) patients, respectively, achieved complete response. With a median follow-up of 29.5 months, median PFS per IRC was 8.5 months (95% CI, 6.0-11.9); median OS was 23.3 months (95% CI, 12.0-not evaluable); median DoR per IRC was not reached. The most frequent treatment-emergent adverse events were decreased white blood cell count (75, 69.4%), decreased neutrophil count (73, 67.6%), and decreased platelet count (47, 43.5%).

conclusionsLipo-MIT monotherapy showed robust and durable antitumor activity with a manageable safety profile, representing a new therapeutic option in relapsed or refractory mature T- and NK-cell lymphoma.

Indexed as

MitoxantroneAdultAgedFemaleHumansLiposomesLymphoma, Extranodal NK-T-CellLymphoma, T-CellMaleMiddle AgedNeoplasm Recurrence, LocalYoung AdultLiposomesMitoxantroneliposomal mitoxantronemature T‐ and NK‐cell neoplasmsmonotherapy

Identifiers

PMID39748491
PMCPMC11695808

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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.