Evidence map›Paper›PMID 41571607›Full record

Trial reportBritish journal of haematology2026

A comprehensive analysis of pirtobrutinib in Chinese patients with chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL): Results from the phase 3 study BRUIN CLL-321.

Shuhua Yi, Jiang Cao, Ru Feng, Keshu Zhou, Lihua Qiu, Fei Li, Hai Yan Yang, Hui Zhou, Wuhan Hui, Jie Cui and 5 more

Abstract readClinical Trial, Phase IIIRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in British journal of haematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. Review
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

15 authors.

Shuhua YiState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.
Jiang CaoDepartment of Hematology, The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.
Ru FengDepartment of Hematology, Nanfang Hospital of Southern Medical University, Guangzhou, China.
Keshu ZhouDepartment of Hematology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.
Lihua QiuDepartment of Lymphoma and National Key Laboratory of Druggability Evaluation and Systematic Translational Medicine, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Tianjin's Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, The Sino-US Center for Lymphoma and Leukemia Research, Tianjin, China.
Fei LiDepartment of Hematology, The First Affiliated Hospital of Nanchang University, Nanchang, China.
Hai Yan YangDepartment of Lymphoma, Zhejiang Cancer Hospital, Hangzhou, China.
Hui ZhouDepartment of Lymphoma & Hematology, Hunan Cancer Hospital, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.
Wuhan HuiDepartment of Hematology, Xuanwu Hospital, Capital Medical University, Beijing, China.
Jie CuiDepartment of Hematology, Gansu Provincial Cancer Hospital, Lanzhou, China.
He HuangDepartment of Medical Oncology, State Key Laboratory of Oncology in Southern China, Collaborative Innovation Center of Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China.
Jiankun ZhuEli Lilly and Company, Shanghai, China.
Xiuhui YeEli Lilly and Company, Shanghai, China.
Jeff SharmanWillamette Valley Cancer Institute and Research Center, US Oncology Research, Eugene, Oregon, USA.
Lugui QiuState Key Laboratory of Experimental Hematology, National Clinical Research Center for Blood Diseases, Haihe Laboratory of Cell Ecosystem, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Tianjin, China.

Funding

Eli Lilly and Company
6 · The paper itself

Abstract

BRUIN CLL-321 is the first prospective, randomized study conducted in covalent BTK inhibitor (cBTKi) pretreated chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL) patients. In this heavily pretreated population, pirtobrutinib significantly improved progression-free survival (PFS) compared to investigator's choice (IC) of idelalisib/rituximab (IdelaR) or bendamustine/rituximab (BendaR). This report presents results from Chinese patients enrolled in BRUIN CLL-321, who were randomized 1:1 to pirtobrutinib (200 mg once daily) or IC of BendaR (idelalisib is not approved in China). End-points included independent review committee (IRC)-assessed PFS, investigator (INV)-assessed PFS, overall survival (OS), event-free survival (EFS), time to next treatment (TTNT) and safety. Among 40 Chinese patients (pirtobrutinib n = 19; BendaR n = 21), IRC-assessed PFS favoured pirtobrutinib (stratified hazard ratio [HR] = 0.281; 95% confidence interval [CI], 0.070-1.125, nominal p = 0.0554), with median PFS not reached versus 10.6 months with BendaR; INV-assessed PFS supported these findings. TTNT (HR = 0.150; 95% CI, 0.031-0.728) and EFS (HR = 0.322; 95% CI, 0.094-1.101) were also improved. A trend towards OS benefit was observed (HR = 0.343; 95% CI, 0.031-3.787). Pirtobrutinib showed a favourable safety profile, with fewer grade ≥3 treatment-emergent adverse events (36.8% vs. 93.3%) and serious adverse events (15.8% vs. 46.7%). These findings support pirtobrutinib as a clinically active and tolerable option for cBTKi-pretreated Chinese CLL/SLL population.

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellProtein Kinase InhibitorsPyrimidinesAdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsChinaEast Asian PeopleFemaleHumansMaleMiddle AgedPyrazolesRituximabpirtobrutinibProtein Kinase InhibitorsPyrazolesPyrimidinesRituximabcBTKi‐pretreatedChinaCLL/SLLpirtobrutinib

Identifiers

PMID41571607
PMCPMC12995541

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

None linked

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.