Evidence map›Paper›PMID 32393328›Full record

Trial reportJournal of hematology & oncology2020

Treatment of relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with the BTK inhibitor zanubrutinib: phase 2, single-arm, multicenter study.

Wei Xu, Shenmiao Yang, Keshu Zhou, Ling Pan, Zengjun Li, Jianfeng Zhou, Sujun Gao, Daobin Zhou, Jianda Hu, Ru Feng and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of hematology & oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03206918 (A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase), which is not on this map. Cited by 72 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
72citing papers in PubMed, 3 pooled it
12.3field-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.

NCT03206918 phase2completednot on this map

A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate Safety and Efficacy of BGB-3111, a Bruton's Tyrosine Kinase (BTK) Inhibitor in Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

TypeinterventionalSponsorBeiGeneRan2017 to 2020Enrolled91ConditionsRelapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic LymphomaArmsZanubrutinib
3 · Its place in the literature

Who cites it

72 citing papers in PubMed, 3 syntheses or guidelines pooled it, 129 citations in OpenAlex.

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12 more citing papers are in PubMed but not listed here.

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 at 13 institutions in 1 country.

Wei XuDepartment of Hematology, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China.
Shenmiao YangPeking University Peoples Hospital, Peking University Institute of Hematology, Beijing, China.
Keshu ZhouHenan Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.
Ling PanWest China Hospital of Sichuan University, Chengdu, China.
Zengjun LiBlood Disease Hospital, Chinese Academy of Medical Science, Tianjin, China.
Jianfeng ZhouTongji Hospital, Tongji Medical College, Wuhan, China.
Sujun GaoThe First Hospital of Jilin University, Changchun, China.
Daobin ZhouPeking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.
Jianda HuFujian Institute of Hematology, Fujian Provincial Key Laboratory of Hematology, Fujian Medical University Union Hospital, Fuzhou, China.
Ru FengNanfang Hospital of Southern Medical University, Guangzhou, China.
Haiwen HuangThe 1st Hospital of Soochow University, Suzhou, China.
Meng JiBeiGene (Beijing) Co., Ltd., Beijing, China.
Haiyi GuoBeiGene (Beijing) Co., Ltd., Beijing, China.
Jane HuangBeiGene (Beijing) Co., Ltd., Beijing, China.
William NovotnyBeiGene (Beijing) Co., Ltd., Beijing, China.
Shibao FengBeiGene (Beijing) Co., Ltd., Beijing, China.
Jianyong LiDepartment of Hematology, Jiangsu Province Hospital, Collaborative Innovation Center for Cancer Personalized Medicine, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Nanjing, 210029, Jiangsu, China. lijianyonglm@126.com.ORCID 0000-0002-9931-4055
BeiGene (China) · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFujian Medical University · CNInstitute of Hematology & Blood Diseases Hospital · CNJiangsu Cancer Hospital · CNJiangsu Province Hospital · CNJilin University · CNNanfang Hospital · CNPeking University · CNSichuan University · CNSoochow University · CNTongji Hospital · CNZhengzhou University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBruton tyrosine kinase (BTK) inhibitors have demonstrated a high degree of efficacy in the treatment of B cell malignancies characterized by constitutive B cell receptor activation, including chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

methodsThe efficacy and safety of zanubrutinib, an investigational highly selective BTK inhibitor, was evaluated in this single-arm, phase 2 study of Chinese patients with relapsed/refractory CLL/SLL. The primary endpoint was overall response rate as assessed by an independent review committee.

resultsOf the 91 evaluable patients, 77 (84.6%) achieved a response, with three (3.3%), 54 (59.3%), and 20 (22%) patients achieving a complete response, partial response, and partial response with lymphocytosis, respectively, after a median follow-up of 15.1 months. The estimated 12-month event-free rate for duration of response was 92.9%. The most commonly reported grade ≥ 3 adverse events (AEs) were neutropenia (44%), thrombocytopenia (15.4%), lung infection/pneumonia (13.2%), upper respiratory tract infection (9.9%), and anemia (8.8%). The 12-month overall survival rate was 96%. Eight (9.0%) patients discontinued zanubrutinib due to AEs, and seven (8.0%) patients required at least one dose reduction.

conclusionTreatment of patients with relapsed/refractory CLL/SLL with zanubrutinib was generally well tolerated and resulted in a high overall response rate, thereby conferring a favorable benefit-risk profile.

trial registrationProspectively registered in China public registry (CTR20160890) on December 7, 2016: http://www.chinadrugtrials.org.cn/. Retrospectively registered in ClinicalTrials.gov (NCT03206918) on July 2, 2017.

Indexed as

AdultAgammaglobulinaemia Tyrosine KinaseAgedAged, 80 and overAntineoplastic AgentsChinaFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedNeoplasm Recurrence, LocalPiperidinesProtein Kinase InhibitorsPyrazolesPyrimidinesAgammaglobulinaemia Tyrosine KinaseAntineoplastic AgentsBTK protein, humanPiperidinesProtein Kinase InhibitorsPyrazolesPyrimidineszanubrutinibBruton’s tyrosine kinaseChronic lymphocytic leukemiaClinical trialRelapsed/refractoryZanubrutinib

Identifiers

PMID32393328
PMCPMC7216400
OpenAlexW3026096286

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.