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更新于：2025-05-07

Chronic Lymphocytic Leukemia

慢性淋巴细胞白血病

更新于：2025-05-07

基本信息

别名

B Cell CLL、B Cell Chronic Lymphocytic Leukemia、B Cell Leukemia, Chronic

+ [248]

简介

A chronic leukemia characterized by abnormal B-lymphocytes and often generalized lymphadenopathy. In patients presenting predominately with blood and bone marrow involvement it is called chronic lymphocytic leukemia (CLL); in those predominately with enlarged lymph nodes it is called small lymphocytic lymphoma. These terms represent spectrums of the same disease.

关联

626

项与慢性淋巴细胞白血病相关的药物

Obecabatagene autoleucel

欧贝妥基奥仑赛

靶点

CD19

作用机制

CD19调节剂 [+2]

在研机构

Autolus Ltd. [+2]

原研机构

University College London

在研适应症

前体B细胞急性淋巴细胞白血病 [+12]

非在研适应症

复发性弥漫性大B细胞淋巴瘤

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-11-08

Odronextamab

奥德罗奈昔单抗

靶点

CD20 x CD3

作用机制

CD20抑制剂 [+3]

在研机构

Regeneron Pharmaceuticals, Inc. [+2]

原研机构

Regeneron Pharmaceuticals, Inc.

在研适应症

复发性弥漫性大B细胞淋巴瘤 [+16]

非在研适应症-

最高研发阶段批准上市

首次获批国家/地区

欧盟 [+3]

首次获批日期2024-08-22

Givinostat Hydrochloride

吉维诺司他

靶点

HDACs

作用机制

HDAC抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期2024-03-21

1,906

项与慢性淋巴细胞白血病相关的临床试验

NCT06859008

/ Not yet recruiting临床1期IIT

Feasibility of Treating Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma With Zanubrutinib in Combination With the BCL2 Inhibitor, Sonrotoclax, Focusing on Access for Underrepresented Ethnic/Racial Minorities

This phase I trial tests zanubrutinib in combination with sonrotoclax for treating underrepresented ethnic and racial minorities with B-cell non-Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Many racial and ethnic minorities face additional treatment challenges which may lead to poorer outcomes, however, there are fewer racial and ethnic minorities participating in clinical trials. Zanubrutinib, a type of tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Sonrotoclax works by blocking a protein called B-cell lymphoma-2 (Bcl-2). This protein helps certain types of blood cancer cells to survive and grow. When sonrotoclax blocks Bcl-2, it slows down or stops the growth of cancer cells and causes them to die. Zanubrutinib and sonrotoclax have been shown to be an effective treatment for B-cell cancers. Giving zanubrutinib in combination with sonrotoclax may be effective in treating ethnic and racial minorities with relapsed or refractory B-cell non-Hodgkin lymphoma.

开始日期2026-02-07

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06778122

/ Not yet recruitingN/AIIT

A Series of N-of-1 Randomised, Adaptive, Blinded, Placebo-Controlled Trials of Overnight In-Bedroom Air Filtration As Adjuvant Treatment in Reducing Inflammatory Biomarkers Among Survivors of Adult-Onset Cancer with Elevated C-Reactive Protein

The BREATHS trial aims to investigate whether overnight in-bedroom air filtration reduces inflammation and cardiac biomarkers in adult survivors of cancer who are at high risk for cardiovascular complications.
The study consists of individualized experiments (N-of-1 trials) conducted in the home settings of adults residing in densely populated urban areas with the most severe air quality levels in Valencia, Spain, where fine particulate matter (PM2.5) and nitrogen dioxide levels exceed the limits set by the World Health Organization (WHO) and EU Directive.
Participants will be exposed to 3 treatment sets (blinded phase), each consisting of a 14-day period of filtered air using a portable air filtration unit ("true-HyperHepa) and a 14-day period of unfiltered air (using the same portable unit with "sham filters"). The intervention will be administered nightly for a minimum of 7 consecutive hours and will last between 4 and 12 weeks for each participant, contingent upon the demonstration of clinical benefit, defined by a reduction in the levels of the blood biomarker C-reactive protein. An unblinded phase will be implemented for participants who do not experience a clinically meaningful change in CRP. During this phase, they will undergo a 14-day period without treatment, followed by 14-day period of both nightly and daily filtered air therapy.
The primary endpoint of this study is defined as the change in blood concentrations of CRP. The secondary endpoints include the changes in levels of three other noninvasive blood biomarkers associated with inflammation and cardiovascular health, and blood pressure.
Both indoor and outdoor fine particulate matter (PM2.5) exposure concentrations will be continuously monitored in the study.

开始日期2025-09-01

申办/合作机构

University College London

NCT06735664

/ Not yet recruiting临床1期IIT

A Phase I Study of Covalent BTK Inhibitor Zanubrutinib in Combination With a CD3-CD20 Bispecific Antibody Odronextamab in Patients With Richter's Transformation

This phase I trial tests the safety and side effects of zanubrutinib in combination with odronextamab and how well it works in treating patients with Richter's transformation. Zanubrutinib, a tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Odronextamab is a bispecific monoclonal antibody that can bind to two different antigens at the same time. Odronextamab binds to CD20 found on B-cells (a type of white blood cell) and on many B-cell cancers and to CD3 on T-cells (also a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving zanubrutinib in combination with odronextamab may be safe, tolerable and/or effective in treating patients with Richter's transformation.

开始日期2025-08-14

申办/合作机构

City of Hope National Medical Center

[+1]

100 项与慢性淋巴细胞白血病相关的临床结果

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100 项与慢性淋巴细胞白血病相关的转化医学

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0 项与慢性淋巴细胞白血病相关的专利（医药）

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31,373

项与慢性淋巴细胞白血病相关的文献（医药）

2025-12-31·Hematology

Clinical trial participation, clinical care, and patient outcomes by practice setting: a real-world database analysis of patients with Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma

Article

作者: Winfree, Katherine ; Bruno, Debora S. ; Khanal, Manoj ; Escalon, Maricer P. ; Li, Xiaohong ; Hess, Lisa M.

OBJECTIVEThis study was designed to compare treatment patterns, clinical trial participation, and clinical outcomes among patients with small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL) or Mantle cell lymphoma (MCL) by site of care.METHODSA nationwide electronic health record (EHR)-derived de-identified database was utilized for this study. Eligible patients were diagnosed with either CLL or MCL from 2013-2022 who received systemic therapy for their disease. Overall survival (OS) was analyzed using Kaplan Meier method, censoring patients without events at last observation in the database. Cox proportional hazards regression model was used to adjust for baseline covariates.RESULTSA total of 6,372 patients with CLL and 3,411 with MCL met eligibility criteria for this analysis; 13.9% and 22.2%, respectively, were treated in academic settings. Academic settings were associated with higher patient volume and were more likely to treat MCL with CAR-T, enroll patients with CLL or MCL to clinical trials, and care for patients who were younger, White, and for CLL with higher rates of del(17p) mutations (all p < 0.01). Survival was significantly longer among patients treated in academic vs community settings (median OS not reached vs 80.5 months for CLL; 95.6 vs 68.7 months for MCL from start of first-line therapy).DISCUSSIONPatients who received care in academic settings differed from those treated in the community; care in academic settings was associated with significantly longer OS and higher trial participation. Further research is warranted to better understand the factors that may contribute to the observed outcomes.

2025-12-01·Cancer Chemotherapy and Pharmacology

Evaluation of Bruton’s Tyrosine Kinase (BTK) inhibition with alternative doses of ibrutinib in subjects with Chronic Lymphocytic Leukemia (CLL)

Article

作者: Srinivasan, Srimathi ; Haddish-Berhane, Nahor ; Ouerdani, Aziz ; Treijtel, Nicoline ; Perez Ruixo, Juan José ; Valenzuela, Belén ; Smith, Emma ; Desphande, Sanjay

AbstractPurposeTo evaluate alternative ibrutinib dosing regimens that maintain Bruton’s tyrosine kinase (BTK) receptor occupancy over the entire dosing interval for CLL patients using a model-based approach.MethodsIbrutinib inhibits B-cell proliferation via irreversible binding of BTK. As IC50 is not an appropriate parameter to describe the potency of the inhibition in the presence of a covalent binding inhibitor. A BTK covalent binding model was developed using kinact/KI as key parameter to account for covalent binding. The ibrutinib-BTK covalent binding model was used to describe the effect of daily doses of 140, 280, 420 and 560 mg on the proportion of subjects with more than 90% BTK inhibition at steady state trough concentrations. Predictive performance of the model was assessed using the available ibrutinib BTK inhibition data following QD dosing. Model-based predictions were used to identify the minimum ibrutinib QD dose that provides more than 90% inhibition in more than 90% of the subjects.ResultsThe covalent binding model was able to describe the data and predicted that ibrutinib QD dose reduced from 420 mg to 280 mg or 140 mg may inhibit de novo synthetized BTK efficiently in a CLL population.ConclusionUsing a model-based approach showed that reducing the ibrutinib dosing regimen to 280 mg QD or even 140 mg in case of adverse events could maintain BTK inhibition over the entire dosing interval.

2025-12-01·Journal of Hematopathology

The t(18;22)/IGL::BCL2 translocation defines a unique CLL subtype: association with early treatment initiation

Review

作者: Yang, Shaobin ; Liu, Enbin ; Li, Huilan ; Yao, Jingya ; Hou, Xiaoju ; Lin, Yani ; Chen, Long ; Tian, Xin

The most prevalent BCL2 fusion in B-cell lymphoma involves the IGH gene, attributable to the t(14;18)(q32;q21) translocation; this chromosomal abnormality is predominantly observed in follicular lymphoma (FL) and serves as one of its diagnostic hallmarks. In contrast, the fusion of BCL2 with IGL via the t(18;22)(q21;q11) translocation occurs less frequently. To investigate the clinicopathological characteristics associated with t(18;22)/IGL::BCL2, we conducted an analysis of five cases of B-cell lymphoma exhibiting the t(18;22) translocation. These patients underwent comprehensive diagnostic assessments, including pathological examination, flow cytometry, karyotyping, fluorescence in situ hybridization (FISH) testing, and genome-wide mutation analysis. Simultaneously, we conducted a literature review. All five patients in the study were male and diagnosed with chronic lymphocytic leukemia (CLL). Two patients exhibited an isolated t(18;22) chromosomal abnormality, while the remaining three presented with an additional +12 abnormality. Genetic rearrangements involving BCL2 and IGL were observed in all patients. Immunophenotypic analysis revealed no significant differences between classical CLL and cases with the t(18;22)/IGL::BCL2 translocation. Genetic testing conducted on three patients confirmed the presence of IGHV mutations. Of the three patients for whom treatment information was available, one demonstrated treatment indications at the initial diagnosis, one demonstrated treatment indications 14 months later, both of them did not respond to the Bruton's tyrosine kinase (BTK) inhibitor, and another one did not meet criteria for treatment. A comprehensive literature review identified 51 cases of the t(18;22)(q21;q11) translocation, primarily associated with CLL diagnoses. Detailed clinical trajectories were available for seven patients, among whom four required treatments at initial diagnosis, and two exhibited resistance to BTK inhibitors. Based on our case series and literature review, these cases appeared to have shorter time to first treatment (TTFT); however, more studies are needed. The t(18;22) chromosomal translocation, resulting in IGL::BCL2 fusion, is an infrequent occurrence predominantly observed in cases of CLL. This genetic anomaly frequently coexists with trisomy 12. Preliminary data suggest that these cases may have a shorter TTFT, though larger cohorts are needed for validation.

3,043

项与慢性淋巴细胞白血病相关的新闻（医药）

2025-05-05

·药通社

第二十一家被驳回，该品种原研即将上市！

统计每周药品获批、上市申请、临床申请及审批情况（2025.4.26-2025.5.2）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。本周工作日只有四天，无新药获批上市，但有几款新药的上市申请被受理。百济神州申报的索托克拉片的上市申请获得受理。该上市申请已经被CDE正式纳入优先审评，适用于治疗既往接受过治疗的慢性淋巴细胞白血病（CLL）/ 小淋巴细胞淋巴瘤（SLL）成人患者。公开资料显示，索托克拉片（sonrotoclax）是百济神州在研的新一代BCL2抑制剂。诺华（Novartis）申报的镥[177Lu] 特昔维匹肽注射液一项新适应症上市申请获得受理。诺华（Novartis）申报的镥[177Lu] 特昔维匹肽注射液一项新适应症上市申请获得受理。一致性评价过评仅5个品种，无首家过评，驳回倒是很多，30日发放12个品种的通知件，多个知名品种均被驳回。乙酰半胱氨酸注射液，驳回已经是第二十一家了。该品种过评真是一波三折，不过好消息是乙酰半胱氨酸注射液的原研进度可喜，Zambon已于4月24日完成了资料补充，离获批不远了。企业可以等原研获批之后，再来仿制。扫码加入药通社交流群！1、仿制药一致性评价过评&驳回情况2、仿制药一致性评价申报情况3、新药申请上市情况（含申请进口和申请增加适应症）4、批准临床(默示许可)5、申请临床情况投稿/企业合作/内容沟通：华籍美人（Ww_150525）*添加请注明备注及来意

一致性评价上市批准优先审批临床研究

2025-05-05

·药时代

3718.5亿美元！全球50款最畅销的重磅药物泽布替尼已具上榜实力可排第49名

正文共： 2046字 3图预计阅读时间： 6分钟（图片来源：Pharma Dive）不久前，全球知名媒体Pharma Dive基于2024年年度销售额数据更新了全球Top50重磅药物名单，药时代团队对这份名单进行了较为系统、细致的梳理和有趣的分析。目前里面没有中国公司的产品，本来我们相信，用不了多久，中国公司的产品将榜上有名。可分析之后发现，原来中国公司已经具备上榜的实力了！现在开始逐步分享，希望对广大中国企业和朋友们有点滴参考价值。欢迎批评指正！多谢！销售额合计3718.5亿美元，平均每款74.37亿美元既然上面提到目前排行榜上没有中国药企及其产品，那么就要知道标准是什么，目前的差距有多大。50款重磅药物2024年的年度销售额合计3718.5亿美元，所以平均每款74.37亿美元，中位数59.15亿美元。全球年度销售额排行榜的最高是来自默沙东的新晋药王Keytruda（K药），为294.8亿美元，最低的是来自艾伯维的治疗慢性淋巴细胞白血病的小分子BCL-2抑制剂唯可来（维奈克拉），为25.8亿美元。所以，这份排行榜的门槛就是25.8亿美元。现在，我们基于搜索到的信息来看看中国药企的实力和上榜的可能性。百济神州研发的针对套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病（CLL）等一系列适应症的BTK抑制剂泽布替尼（Zanubrutinib，商品名：Brukinsa）是首个在美国获批的中国抗癌药，凭借优于伊布替尼的疗效数据快速放量。根据2024年百济神州全年业绩公告，其核心产品泽布替尼（商品名百悦泽）的全球销售额为‌26.44亿美元‌（约合人民币188.59亿元），同比增长105%，占公司总营收的69.3%。如果采用26.44亿美元这个数据，那么百济神州的泽布替尼不仅可以上榜，而且可以位居第49名，取代阿斯利康的C5补体蛋白产品舒立瑞，因为后者2024年的销售额是25.9亿美元，这也意味着，艾伯维的唯可来（维奈克拉）将被挤出TOP50排行榜。百济神州的另一款重磅产品，治疗非小细胞肺癌、霍奇金淋巴瘤的PD-1抑制剂替雷利珠单抗（Tislelizumab，商品名：百泽安）通过与诺华合作拓展欧美市场，2024年全球销售额约6.21亿美元。另一款来自中国的PD-1抑制剂则是信达生物的信迪利单抗（Sintilimab，商品名：达伯舒）。信达负责大中华区市场，海外授权礼来共同开发，虽然美国上市受阻，但东南亚市场增长。2024年全球销售额：约5.26亿美元。有实力冲击排行榜的后备军包括：恒瑞医药的PD-1抑制剂卡瑞利珠单抗（Camrelizumab，商品名：艾瑞卡）获批的适应症主要包括肝癌、食管癌，面临的挑战包括国内集采降价压力，海外布局取得新进展很关键。复星医药的复必泰（mRNA新冠疫苗，与BioNTech合作），2024年全球销售额因疫情需求减少较2023年下降，市场主要在中国港澳台及东南亚地区。恒瑞医药的吡咯替尼（Pyrotinib，商品名：艾瑞妮），针对HER2阳性乳腺癌，是中国首个原创HER2靶向药，东南亚市场表现亮眼。康方生物的卡度尼利单抗（PD-1/CTLA-4双抗，AK104），作为全球首个PD-1/CTLA-4双抗，定价优势显著。信达生物的PCSK9抑制剂信必乐（IBI306），中国首个自主研发的PCSK9抑制剂，2023年8月获批上市，主打适应症高胆固醇血症，定价更低（年治疗费用约2万元人民币，仅为进口药的1/3）。中国新药全球化的挑战与机遇“不出海，就出局。要上榜，先出海！”现在，中国制药界已经达成以上共识。中国创新药全球化面临专利布局、市场竞争和政策环境的多重考验，加速海外临床和商业化进程仍是关键挑战；在PD-1、GLP-1、ADC、TCE等拥挤赛道中，差异化布局成为突破口。国内集采政策倒逼药企转向创新与国际化，而欧美市场之外其它国家和地区的准入则是下一步发展的核心。药时代将持续跟踪报道，欢迎广大朋友们关注、批评指正！参考资料：Pharma Dive官网38笔！596亿美元！跨国药企2025年重磅交易达成，中国公司贡献很大关税阴云下，大型药企并购热情不减，哪些中国药企可能被收购？2024年制药行业并购TOP1028.4亿美元！4月中国创新药出海汇总其它公开资料图片来源：微信订阅号AI38笔！596亿美元！跨国药企2025年重磅交易达成，中国公司贡献很大2025-05-02【直击现场】「星起点」宣讲会直播：50万资金+专家辅导，寻找下一个代谢病创新药突破者！2025-04-30百济神州索托克拉冲刺上市，引领BCL2抑制剂新纪元！2025-04-30版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!

财报上市批准医药出海

2025-05-05

·Pharmaceutical Technology

Chinese regulator grants priority review for InnoCare’s solid tumour treatment

The therapy is intended for individuals suffering from advanced solid tumours with neurotrophic tyrosine receptor kinase fusion genes. Credit: Chay_Tee/Shutterstock. China National Medical Products Administration’s (NMPA) Center for Drug Evaluation (CDE) has granted priority review for InnoCare Pharma’s zurletrectinib (ICP-723) for advanced solid tumours harbouring neurotrophic tyrosine receptor kinase (NTRK) fusion genes. Previously, the CDE had accepted the new drug application (NDA) for the pan-tropomyosin receptor kinase (TRK) inhibitor, which demonstrated better safety and efficacy in a registration clinical trial. InnoCare Pharma CEO, chairman, and co-founder Dr Jisong Cui said: “I am very pleased that zurletrectinib has been included in the priority review. As a new broad-spectrum anticancer drug, zurletrectinib has demonstrated outstanding efficacy and safety. “We look forward to bringing better treatment options to patients with solid tumours as soon as possible.” In January last year, the company dosed the first paediatric subject with zurletrectinib at the Sun Yat-sen University Cancer Center in China, launching clinical research for children aged 2 to 12 years. This milestone followed good efficacy and safety results in adults and adolescents aged 12 to 18 years. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Last month, the NMPA approved the company’s Bruton’s tyrosine kinase (BTK) inhibitor orelabrutinib as a first-line treatment for chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The therapy is now approved for three indications: relapsed and refractory (R/R) CLL/SLL, R/R marginal zone lymphoma (R/R MZL) and R/R mantle cell lymphoma (R/R MCL). The company’s portfolio includes various new drug products at clinical, preclinical research and development, and commercialisation stages. It operates out of branches in China, Hong Kong, and the US.

优先审批上市批准申请上市