ITCC-104: HEM-iSMART International Proof of Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory HEMatological Malignancies in Children, Sub-Protocol E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies

HEM-iSMART is a master protocol which investigates multiple investigational medicinal products in children, adolescents and young adults (AYA) with relapsed/refractory (R/R) ALL and LBL. Sub-protocol E is a phase I/II trial evaluating the safety and efficacy of capivasertib + venetocolax in combination with dexamethasone in children and AYA with R/R ped ALL/LBL whose tumor present with alterations of the PAM pathway, or lacking any mutations.

开始日期2026-10-01

申办/合作机构

Princess Maxima Centre For Pediatric Oncology

[+2]

NCT07311746

/ Not yet recruiting临床1/2期IIT

Phase Ib/II Trial of Cladribine/Ruxolitinib/Venetoclax in Patients With Relapsed/Refractory T-cell Prolymphocytic Leukemia

The goal of this clinical research study is to learn if the combination of ruxolitinib with cladribine and venetoclax can help to control the disease in patients with R/R T-PLL.

开始日期2026-06-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT07153497

/ Not yet recruiting临床2期IIT

A Randomized Phase 2 Trial of Olutasidenib-Based Therapies in Patients With Newly Diagnosed IDH1-Mutant Myeloid Malignancies: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment substudy tests the addition of olutasidenib to usual treatment in patients with higher-risk myelodysplastic syndrome (MDS) or patients with acute myeloid leukemia (AML) with a mutation in the IDH1 gene. Olutasidenib blocks the protein made by the mutated IDH1 gene. Blocking this protein may help keep cancer cells from growing. For patients with MDS, olutasidenib will be added to decitabine-cedazuridine (also called ASTX727). Decitabine is in a class of medications called hypomethylating agents and is the standard treatment for MDS. It works by helping the bone marrow produce normal blood cells and by killing abnormal cells in the bone marrow. The cedazuridine makes it possible to take the decitabine by mouth. Adding olutasidenib to the usual treatment for MDS (ASTX727) may increase the likelihood of going into remission. For patients with AML, olutasidenib and ASTX727 will be combined with venetoclax, a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. Venetoclax may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Adding olutasidenib to the usual treatment for AML (ASTX727 and venetoclax) may increase the likelihood of going into remission. For low risk MDS, the substudy tests whether giving olutasidenib alone helps improve blood counts.

开始日期2026-05-27

申办/合作机构

National Cancer Institute

100 项与维奈克拉相关的临床结果

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100 项与维奈克拉相关的转化医学

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100 项与维奈克拉相关的专利（医药）

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4,643

项与维奈克拉相关的文献（医药）

2026-02-01·COMPUTATIONAL BIOLOGY AND CHEMISTRY

GC/MS analysis and computational evaluation of C. cinerea EO constituents for colorectal cancer: Molecular docking, dynamics, and quantum chemical insights into Cis-Verbenyl acetate

Article

作者: Bekkar, Yahia ; Bouraoui, Rania ; Neghmouche Nacer, Salah ; Lanez, Touhami ; Bourougaa, Lotfi ; Lanez, Elhafnaoui ; Garzoli, Stefania ; Larbi Benamor, Mohammed ; Samah, Bouchagra

The essential oil of Cotula cinerea was subjected to gas chromatography-mass spectrometry (GC-MS) analysis, leading to the identification of 31 chemical constituents. The major compounds were selected for comprehensive computational investigations to explore their potential anti-colorectal cancer activity. Among the identified constituents, cis-verbenyl acetate (CVA) exhibited the most favorable binding affinities across a panel of fifteen protein targets implicated in colorectal cancer. Notably, Tankyrase1 (PDB ID: 4OA7) and Tankyrase2 (PDB ID: 4UFU) emerged as the most promising targets, with docking scores of -9.49 and -8.46 kcal/mol, respectively. Molecular dynamics simulations conducted over 300 nanoseconds demonstrated the structural stability and sustained interactions of the CVA-protein complexes, characterized by low root mean square deviation (RMSD) values and limited conformational fluctuations. These findings were corroborated by molecular mechanics Poisson-Boltzmann surface area (MM-PBSA) calculations, which revealed highly favorable binding free energies, particularly in the CVA- TNKS2 complex (ΔGtotal = -45.64 kcal/mol). In silico ADMET profiling indicated high oral bioavailability and low predicted toxicity for CVA compared to native ligands. Furthermore, density functional theory (DFT) analysis provided insight into the electronic properties of CVA, revealing a stable electronic configuration, suitable frontier molecular orbital energies, and a well-distributed electrostatic potential surface. Thermodynamic evaluations supported its chemical stability, showing a consistent increase in entropy, enthalpy, and heat capacity with rising temperature. Collectively, these computational findings suggest that CVA is a thermodynamically stable, pharmacokinetically favorable, and potentially bioactive compound with dual-target affinity against colorectal cancer-related proteins, meriting further experimental validation.

2026-02-01·BIOORGANIC CHEMISTRY

Zinc(II)–berberine-based complexes targeting mitochondria exhibit enhanced antiproliferative activity as single drugs or in combination with ABT-199

Article

作者: Liang, Hong ; Wu, Run-Chun ; Qin, Aimiao ; Qin, Qi-Pin ; Wang, Zhen-Feng ; Zhang, Shu-Hua ; Huang, Xiao-Qiong ; Tan, Min-Xiong

Myeloid cell leukemia-1 (Mcl-1), a protein mainly located in mitochondria, exhibits antiapoptotic activity, promoting tumor growth. Herein, we designed an innovative strategy for targeting mitochondria to inhibit Mcl-1 expression effectively. To this end, we synthesized a novel berberine-based ligand, BerT. We also synthesized and comprehensively characterized its corresponding Zn(II) complexes, including [Zn(BerT)(H₂O)Cl₂] (BerT1), [Zn(BerT)(ppe)Cl]Cl (BerT2), [Zn(BerT)(ipq)Cl]Cl (BerT3), [Zn(BerT)(phe)Cl]Cl (BerT4), [Zn(BerT)(bph)Cl]Cl (BerT5), [Zn(BerT)(dph)Cl]Cl (BerT6), [Zn(BerT)(pha)Cl]Cl (BerT7) and [Zn(BerT)(mph)Cl]Cl (BerT8) [ppe = 1,2-bis(diphenylphosphino)ethane, ipq = 2-(1H-imidazo[4,5-f][1,10]phenanthrolin-2-yl)quinolin-8-ol, phe = 1,10-phenanthroline, bph = bathophenanthroline, dph = 4,7-dichloro-1,10-phenanthroline, pha = 1,10-phenanthrolin-5-amine and mph = 5,6-dimethyl-1,10-phenanthroline]. In human breast MDA-MB-231cancer cells, compounds BerT1-BerT8 exhibited potent cancer growth inhibitory capability ranging (IC₅₀ = 0.52-1.97 μM), as compared to cisplatin (IC₅₀ = 10.04 ± 0.61 μM). BerT1 and BerT3 exhibited intrinsic green fluorescence, indicating their potential utility in mitochondrial imaging applications. To the best of our knowledge, BerT1 and BerT3 are the first Zn(II)-berberine-based complexes that target mitochondria. They can selectively bind to Mcl-1 with high affinity, exhibiting enhanced anticancer efficacy in MDA-MB-231 tumor cells. These two complexes also caused Bax/Bak-dependent apoptosis in MDA-MB-231 cells and acted synergistically with ABT-199 to kill ABT-199 resistant cells in multiple tumor models. BerT3 was effective and tolerable as a single probe or in combination with ABT-199 in MDA-MB-231 BALB/c mouse models. Thus, we conclude that Zn(II)-berberine-based derivatives have potential for the non‑platinum drugs development aimed at treating cancer tissue.

2026-02-01·MYCOPATHOLOGIA

Concurrent Administration of Triazoles with Chemotherapeutic and/or Immunosuppressant Agents Known to Have Moderate-to-Severe Drug-Drug Interactions in Patients with Hematologic Malignancies Hospitalized for Invasive Aspergillosis

Article

作者: Walsh, Thomas J ; Coleman, Craig I ; Johnson, Melissa D ; Alexander, Barbara D ; Lovelace, Belinda

Abstract:

Background:

Triazoles are widely used for treatment and prevention of invasive aspergillosis (IA) but can cause serious drug-drug interactions (DDIs) with chemotherapeutic (CT) and immunosuppressant (IS) agents via CYP3A4 inhibition. The frequency of triazole-CT or IS concurrent administration in hematologic malignancies (HM) patients newly admitted with IA is largely unknown.

Methods:

We studied US IQVIA claims including adults with ≥ 1 claim for an inpatient stay with a diagnosis code for IA from October 1, 2015-November 30, 2022 and evidence of systemic antifungal therapy for ≥ 3 days during the hospitalization. The cohort was limited to patients with ≥ 1 HM diagnosis code within 6 months prior to IA admission. Utilization of triazoles with CT and/or ISs known to have moderate-to-severe pharmacokinetic (PK) interactions was described.

Results:

Triazoles, predominantly isavuconazole (61.0%) and voriconazole (53.6%), were administered in 97.2% of 317 patients with IA. Of these, 241 (78.2%) received an interacting CT and/or IS. Potentially interacting agents administered with a triazole included corticosteroids (70.8%), calcineurin or mammalian target of rapamycin (mTOR) inhibitors (25.0%) (84.4% tacrolimus), alkylating agents (14.0%) (76.7% cyclophosphamide), venetoclax (9.7%), anthracyclines (6.2%), and vincristine (5.8%).

Conclusions:

Concurrent administration of triazole with potential PK interactions with CT or IS agents occurred in most HM patients admitted for IA. Choosing alternative antifungals, therapeutic drug monitoring of triazoles or selective ISs, and dosage adjustment of CT/IS agents may mitigate the risk of adverse DDIs. New antifungal agents without serious DDIs with CT and/or IS agents are needed for treatment of IA to reduce the risk of serious adverse events.

1,996

项与维奈克拉相关的新闻（医药）

2026-01-18

·ioncology

【研究聚焦】AML合并骨髓纤维化：不可忽视的影响

点击蓝字关注我们引言聚焦BMT前沿·解码移植突破 —— 中国医学科学院血液病医院（中国医学科学院血液学研究所）造血干细胞移植中心系列研究亮相国际造血干细胞移植领域高影响力期刊《Bone Marrow Transplantation》在造血干细胞移植这场与生命赛跑的征途中，精准治疗和科学创新正不断刷新患者的“治愈希望”。作为中国年移植量最大、技术最全面的移植中心之一，中国医学科学院血液病医院（中国医学科学院血液学研究所）造血干细胞移植中心长期致力于推动移植技术升级、疗效优化与安全可及。在急性髓系白血病（AML）的治疗中，很多人关注的是化疗方案、移植机会和基因突变，却常常忽略了另一个重要的“变量”——骨髓纤维化（BMF）。简单理解，骨髓纤维化，就是骨髓这片“造血土壤”里，多长出了一些“纤维杂草”，环境变得不那么理想了。值得注意的是，急性髓系白血病（AML）合并骨髓纤维化（BMF），不是原发性骨髓纤维化（PMF）进展为急性白血病，两者机制和临床意义完全不同。那么，AML合并BMF会带来什么影响呢？中国医学科学院血液病医院（中国医学科学院血液学研究所）造血干细胞移植团队研究发现，这个看似病理报告中的“小细节”，其实可能决定患者移植后的复发风险和长期生存。我们的研究中国医学科学院血液病医院（中国医学科学院血液学研究所）造血干细胞移植团队，依托NICHE前瞻队列，分析了2014–2023年 532例初诊并接受异基因移植的AML患者。根据欧洲标准，患者分为三组： · BMF-0：无纤维化 · BMF-1：轻度纤维化 · BMF-2-3：中重度纤维化研究发现（1）预后差异明显 · BMF-2-3组的总体生存和无病生存显著降低； · 复发风险显著增加； · 多因素分析表明：中重度BMF是移植前完全缓解患者移植后复发的独立危险因素。（2）基因特征各不相同 · BMF-2-3患者更常见 U2AF1、TP53、ETV6 等高危突变； · BMF-0患者则更常见 CEBPA 突变，往往预示预后更好。这意味着纤维化不仅是“形态学改变”，还和基因背景紧密相关。（3）恢复速度减慢 · BMF-2-3患者移植后，中性粒细胞、血小板和B、NK等免疫细胞恢复都比较慢； · 换句话说，这类患者需要更多时间“蓄力”，医生也需要更长时间的支持和监测。国际对比有意思的是，在我们的报道后，来自MD Anderson的化疗队列研究在JHO杂志上也报道：AML合并重度骨髓纤维化的患者，接受不同强度的化疗缓解率更低、生存期更短。值得一提的是，他们发现在MF 0-1的AML患者中，含维奈托克的治疗方案的CR/CRi率84.1%，显著高于不含维奈托克的治疗方案（63%，P=0.010）。但加用维奈托克对AML合并MF 2-3的CR/CRi率没有任何影响（50%对46.7%，P=0.914），这可能提示骨髓纤维化可能是介导维奈克拉耐药的因素之一。因此，中重度BMF在不同人群中都被验证为一个不利因素。总结 · 骨髓纤维化不是“附带的小发现”，而是会真正影响AML患者移植结局的重要因素。 · 它关联遗传学特征、移植后复发风险、造血和免疫恢复速度。 · 未来AML风险分层评估里，BMF分级值得列入常规考量。一句话总结 AML伴随的骨髓纤维化，就像土壤里的“硬结块”，可能让移植之路更坎坷。认识它、评估它，才能更好地帮助患者走向长期生存。姜尔烈教授中国医学科学院血液病医院（中国医学科学院血液学研究所）干细胞移植中心主任出诊时间：海光寺院区周三上午；团泊院区周二上午医学博士、主任医师、博士生（后）导师中国初级卫生保健基金会造血干细胞移植专委会主任委员 CSCO白血病专委会主任委员中国血液病专科联盟白血病自体移植协作组组长中华医学会血液学分会造血干细胞应用学组副组长中国抗癌协会血液肿瘤专业委员会常务委员，造血干细胞移植与细胞治疗学组副组长 CSCO自体造血干细胞移植工作组副组长天津市抗癌协会常务理事天津市血液与再生医学学会副理事长《中华血液学杂志》、《白血病·淋巴瘤》等杂志编委张海啸博士生中国医学科学院血液病医院（中国医学科学院血液学研究所） 2024届博士,导师为姜尔烈教授主要研究方向：血液肿瘤和造血干细胞移植发表论文20余篇，其中以第一/通讯作者在Journal of Hematology &Oncology、 Experimental Hematology &Oncology 、American Journal of Hematology、Cellular and Molecular Life Sciences、Bone Marrow Transplantation 等杂志发表文章9篇，累计影响因子超过90分。撰稿：张海啸编辑：邓韩校对：颜洁张海啸审核：颜洁曹易耕姜尔烈来源：中国医学科学院血液病医院（中国医学科学院血液学研究所）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床研究ASH会议临床结果申请上市

2026-01-17

·GlobeNewswire-Health Care

SELLAS Life Sciences Enters Agreement with IMPACT-AML to Expand SLS009 Clinical Program into Europe

Supports capital-efficient expansion of the SLS009 clinical program into frontline AML, enabling broader U.S. and European patient enrollment U.S. enrollment evaluating SLS009 in combination with AZA/VEN in newly diagnosed AML with high-risk features is planned for Q1 2026, with European enrollment anticipated in Q2 2026 Jan. 14, 2026 -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that it has entered into an agreement with IMPACT-AML, a European collaborative initiative dedicated to advancing innovative treatments for patients with acute myeloid leukemia (AML). Under the agreement, the IMPACT-AML network will conduct a clinical study evaluating SLS009, a highly selective CDK9 inhibitor, enabling access to multiple European clinical sites and patients. IMPACT-AML is a pan-European project and builds an inclusive clinical network (STREAM platform) that connects patients, clinicians, and researchers to test novel AML therapies and improve patient outcomes (https://impactaml.eu/). It is part of the prestigious EU Mission Cancer program and a top-tier scientific cluster. The IMPACT-AML project is led by a consortium of major research and clinical institutions in Europe, including IRST (IRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori”), the University of Bologna, IIS LA FE (Health Research Institute Hospital La Fe), several European AML collaborative groups, and supranational organizations under the umbrella of the European Leukemia Net (ELN), as well as various university hospitals across Europe. By leveraging IMPACT-AML’s existing infrastructure and expertise, SELLAS expects to expand European patient access to SLS009 in a highly cost-efficient manner while supporting broader participation across the clinical program. “This is a highly meaningful milestone for SELLAS and for the SLS009 program,” said Angelos Stergiou, M.D., Sc.D., President and Chief Executive Officer of SELLAS. “Gaining access to the IMPACT-AML framework represents strong external validation of SLS009 and reflects the growing recognition of SLS009’s potential in addressing critical unmet needs in AML. Importantly, this collaboration allows us to efficiently expand our clinical program into Europe by leveraging an established infrastructure, significantly improving capital efficiency while supporting broader and faster patient enrollment as we advance the program into frontline AML.”The collaboration is expected to support the continued execution of the SLS009 clinical program as SELLAS advances into frontline AML. The study in Europe is planned to enroll approximately 40 patients to evaluate SLS009 in combination with azacitidine and venetoclax (AZA/VEN) in patients with newly diagnosed AML with high-risk features. Enrollment in the first part of the trial for newly diagnosed patients is expected to begin at U.S. sites in Q1 2026, followed by initiation at European sites in Q2 2026, subject to regulatory and site readiness. “IMPACT-AML is committed to accelerating access to promising new therapeutic approaches for patients with AML who face limited treatment options,” said IMPACT-AML Scientific Coordinator, Dr. Giovanni Martinelli. “We are pleased to collaborate with SELLAS and support the evaluation of SLS009 within our European network, consistent with our mission to facilitate efficient, high-quality clinical research in AML.” SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. The content above comes from the network. if any infringement, please contact us to modify.

临床研究

2026-01-17

·医脉通血液科

精准突破，指导实践：《利沙托克拉治疗血液系统恶性肿瘤临床应用指导原则（2025年版）》重磅发布

慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）是一种常见的B细胞恶性血液肿瘤。2025年7月，全新一代BCL-2抑制剂利沙托克拉正式获得中国国家药品监督管理局（NMPA）批准，用于既往经过至少包含布鲁顿酪氨酸激酶（BTK）抑制剂在内的一种系统治疗的成年CLL/SLL患者。作为我国首个原创的全新一代BCL-2抑制剂，利沙托克拉实现了通过第1天至第5天的剂量递增，第6天即可达到最佳治疗剂量，为CLL／SLL患者带来了新的有效治疗选择，方便患者用药和医生临床管理。此外，利沙托克拉给药后可快速达到最佳峰浓度，开启细胞凋亡通路；半衰期仅5h，没有药物药物相互作用，药物不会在体内蓄积，在获得更好疗效的同时，降低了肿瘤溶解综合征（TLS）和骨髓抑制等不良反应的发生率1。利沙托克拉的上市，为患者提供了治疗新选择，也标志着中国创新药研发领域取得了又一重要进展。为进一步提升该药物规范应用，由CSCO白血病专家委员会牵头制定的《利沙托克拉治疗血液系统恶性肿瘤临床应用指导原则（2025年版）》1，在1月16日召开的CSCO白血病、淋巴瘤及骨髓瘤专家委员会工作会议暨2026年CSCO血液肿瘤学术大会上正式发布。本文特邀指导原则通讯作者哈尔滨血液病肿瘤研究所马军教授，深度解读指导原则的亮点及临床转化价值，并剖析利沙托克拉为血液系统恶性肿瘤患者带来的生存获益。马军教授CSCO现场照片指导原则发布仪式照片创新驱动，优势凸显：利沙托克拉优化BCL-2抑制剂诊疗路径利沙托克拉作为全新一代BCL-2抑制剂，其结构增强了利沙托克拉的靶点亲和力和抗肿瘤活性，使其具有更理想的药代动力学特点。首先，利沙托克拉实现了通过第1天至第5天的剂量递增，第6天即可达到最佳治疗剂量，简化了临床管理流程，提升了治疗依从性和便捷性；其次，由于药物在体内无蓄积，且无药物药物相互作用，使得利沙托克拉与BTK抑制剂、CD20单抗等联合用药无需导入期，优化给药方案从而快速获得疾病缓解；利沙托克拉抗肿瘤效应由Cmax驱动，一旦达到触发浓度，抗凋亡通路就会开启，不依赖长半衰期。从而实现更低的TLS风险及可控的骨髓抑制，为长期治疗管理奠定了良好安全性基础1。从关键循证到全面规范，指导原则奠定精准实践基石本指导原则的核心内容，建立在关键性临床研究的数据基础之上。在针对复发/难治性CLL/SLL（R/R CLL/SLL）的关键Ⅱ期研究中，所有患者均经BTK抑制剂治疗失败，其中45.5%免疫化疗治疗失败，复杂核型（CK）患者占总人群的42.9%，del(17p)/TP53突变合并CK或高危复杂核型（high CK）患者占比近30%，在72例可评估的患者中，利沙托克拉单药治疗独立审查委员会评估的客观缓解率（ORR）达到62.5%，中位缓解持续时间（DOR）为27.66个月，中位无进展生存期（PFS）为22.21个月。尤为关键的是，在整个研究期间，未报告任何临床或实验室确诊的TLS事件，这一数据印证了其良好的安全性管理优势。在探索联合治疗策略的研究中，利沙托克拉展现出良好协同潜力。利沙托克拉联合阿可替尼治疗R/R CLL/SLL患者，ORR高达96.9%。更值得注意的是，在经维奈克拉治疗后复发难治的患者中，该联合方案仍取得了92.9%的ORR，展现出克服耐药潜力1。然而，创新疗法的广泛应用亟需规范指引。本次发布的指导原则，系统性地阐述了从药物作用机制、临床研究证据、具体用法用量、不良反应管理到特殊人群用药的全维度应用原则，旨在将坚实的循证医学证据转化为标准化、可推广的临床实践，为CLL/SLL乃至更广泛的血液肿瘤治疗贡献了高质量的“中国标准”。在用法用量上，指导原则明确规范了从20mg起始的标准化5日剂量递增路径，及后续600mg标准治疗剂量。在临床管理上，提供了基于TLS危险度的TLS预防和管理措施，包括水化、降尿酸治疗和血生化监测频率的具体建议。在不良反应处理上，不仅列出了常见的血液学及非血液学不良反应，更给出了清晰的剂量调整原则（如首次减量至400mg，再次减量至200mg）和支持治疗建议，帮助医生积极干预，推动治疗连续性。同时，指导原则也明确了肝肾功能不全患者、老年人群等特殊群体的用药注意事项，充分体现了个体化治疗的理念。此外，指导原则以前瞻性的视野，系统梳理了利沙托克拉在更广泛血液系统恶性肿瘤中的探索性应用证据。在急性髓系白血病（AML）治疗领域，针对不适合强化疗的老年或虚弱患者，利沙托克拉联合阿扎胞苷可以带来64.1%-72.7%的ORR，为这部分预后极差的患者带来了新的生存希望。在经维奈克拉治疗的R/R AML患者中，利沙托克拉联合AZA治疗的ORR为31.8%，CR+CRi率22.8%，在治疗后缓解的患者中，超半数存在TP53突变。表明利沙托克拉联合治疗具有克服维奈克拉耐药的潜力。在较高危的骨髓增生异常综合征（HR-MDS）患者中，联合疗法同样取得了鼓舞人心的疗效，初诊的HR-MDS患者CR率高达40%。有望为AML及HR-MDS临床治疗带来更多选择。此外，在多发性骨髓瘤（MM）、华氏巨球蛋白血症（WM）等疾病的早期研究中，利沙托克拉也显示出良好的应用潜力。目前，利沙托克拉在AML和MDS的全球多中心Ⅲ期注册研究已全面展开，未来研究成果有望进一步拓展其治疗版图。专家点评马军教授《利沙托克拉治疗血液系统恶性肿瘤临床应用指导原则（2025年版）》在2026年CSCO血液肿瘤学术大会期间发布，具有明确的临床指导意义。这标志着首个中国原研BCL-2抑制剂的临床应用，已从研究证据阶段进入规范化实践阶段。本指导原则的核心价值在于“衔接证据与临床”。它系统总结了利沙托克拉在CLL/SLL患者中的疗效与安全性数据，为其在该人群中的应用提供了明确依据。值得注意的是，利沙托克拉独特的5天快速剂量递增方案、良好的安全性，尤其是低TLS发生率，切实解决了临床应用中诸如：住院监测周期长、联合用药受限、安全性管理等痛点，提升了患者疗效和生活质量。此外，利沙托克拉在AML、MDS等领域的早期积极数据，则为我们打开了全新的探索空间，提供了有效的临床治疗选择。归根结底，任何前沿治疗方案的最终价值，都体现在规范的应用和患者获益中。我们期待全国同道能以本指导原则为蓝本，在临床实践中积累更丰富的真实世界经验，共同推动我国血液肿瘤诊疗水平的提升。马军教授主任医师，教授，博士生导师哈尔滨血液病肿瘤研究所所长中国临床肿瘤学会（CSCO）监事会监事长亚洲临床肿瘤学会副主席中国临床肿瘤学会白血病专家委员会常务委员国家卫生健康委能力建设与继续教育中心肿瘤学科专家组组长白血病·淋巴瘤杂志总编辑参考文献： 1. 中国临床肿瘤学会（CSCO）白血病专家委员会. 利沙托克拉治疗血液系统恶性肿瘤临床应用指导原则（2025年版）［J］. 白血病·淋巴瘤，2025，34（12）：714⁃722. 扫码查看《利沙托克拉治疗血液系统恶性肿瘤临床应用指导原则（2025年版）》编辑：Nunu 审校：Irena 排版：Cole 执行：Cole 本平台旨在为医疗卫生专业人士传递更多医学信息。本平台发布的内容，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。如该等信息被用于了解医学信息以外的目的，本平台不承担相关责任。本平台对发布的内容，并不代表同意其描述和观点。若涉及版权问题，烦请权利人与我们联系，我们将尽快处理。戳“阅读原文”，查看更多内容

CSCO会议临床2期临床1期临床结果临床终止

100 项与维奈克拉相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10679	维奈克拉	L01XX52	DB11581

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
复发性套细胞淋巴瘤	日本	AbbVie LLC	2025-03-27
难治性套细胞淋巴瘤	日本	AbbVie LLC	2025-03-27
难治性慢性淋巴细胞白血病	日本	AbbVie LLC	2019-09-20
复发性慢性淋巴细胞白血病	日本	AbbVie LLC	2019-09-20
小淋巴细胞淋巴瘤	美国	AbbVie, Inc.	2018-06-08
成人急性髓性白血病	欧盟	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	冰岛	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2016-12-04
成人急性髓性白血病	挪威	AbbVie Deutschland GmbH & Co. KG	2016-12-04
急性髓性白血病	加拿大	AbbVie AS	2016-10-31
慢性淋巴细胞白血病	美国	AbbVie, Inc.	2016-04-11

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肿瘤溶解综合征	临床3期	美国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	澳大利亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	法国	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	希腊	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	塞尔维亚	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	西班牙	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	中国台湾	AbbVie, Inc.	2024-08-05
肿瘤溶解综合征	临床3期	英国	AbbVie, Inc.	2024-08-05
复发性急性髓细胞白血病	临床3期	美国	Genentech, Inc.	2022-10-01
复发性急性髓细胞白血病	临床3期	美国	AbbVie, Inc.	2022-10-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05799079 (CTgov)	临床2期	复发性急性髓细胞白血病 \| 复发性急性白血病	1	DEC-C+Venetoclax	鬱齋願膚鑰襯築觸襯積 = 築蓋製鹹壓製願繭網顧鹽網繭淵選廠鹹齋窪鹹 (餘衊憲憲鏇製憲構夢願, 憲願製衊範製築夢廠窪 ~ 艱鑰鬱淵繭鬱範醖選遞) 更多	-	2026-01-09
ASH2025	N/A	前体T淋巴细胞白血病淋巴瘤	12	HDAC inhibitor, azacytidine, venetoclax and dexamethasone	築願觸顧窪糧鹽積獵襯(廠鑰蓋製選構鹹鏇壓積) = All patients had at least one adverse event, and the most commonly reported ≥3 grade hematological adverse events included neutropenia (50%), thrombocytopenia (41.7%) and anemia (25%). The incidence of liver function damage and kidney function damage is small, which are 16.7% and 8.3% respectively. The main gastrointestinal adverse events were nausea and vomiting (83.3%). A total of 5 patients developed pneumonia (41.7%), among which 1 patient in ETP group developed ≥3 grade pneumonia and ≥3 grade sepsis; no adverse events of cardiovascular system were reported. 鬱憲蓋餘鹹範齋選鑰鹽 (蓋鬱鹽遞遞憲鹹壓膚範 ) 更多	积极	2025-12-06
ASH2025	N/A	慢性淋巴细胞白血病	112	Venetoclax 100 mg + Ketoconazole 200 mg	網壓鹹餘廠鏇壓積選製(艱鑰築淵築範願廠餘範) = 範蓋築願鬱蓋艱餘築蓋構齋繭艱鑰鏇網願齋構 (積餘廠願醖鑰遞構積鹽 ) 更多	积极	2025-12-06
				Venetoclax 400 mg	網壓鹹餘廠鏇壓積選製(艱鑰築淵築範願廠餘範) = 衊齋鏇糧築願衊糧選鏇構齋繭艱鑰鏇網願齋構 (積餘廠願醖鑰遞構積鹽 ) 更多
ASH2025	N/A	急性髓性白血病	230	VEN-based group	願簾觸遞遞醖齋願衊顧(範築選憲齋艱鬱醖膚淵) = 觸夢艱襯積簾憲鬱壓繭蓋願簾窪鏇齋觸範繭製 (淵蓋鏇齋選積選網顧夢 ) 更多	积极	2025-12-06
				conventional chemotherapy group	願簾觸遞遞醖齋願衊顧(範築選憲齋艱鬱醖膚淵) = 餘構鏇選衊鬱鑰觸積鹽蓋願簾窪鏇齋觸範繭製 (淵蓋鏇齋選積選網顧夢 ) 更多
ASH2025	临床1/2期	急性髓性白血病一线 CD123-positive	49	Pivekimab sunirine+Venetoclax+Azacitidine	構衊構積範壓襯鏇醖鹹(網艱糧淵襯簾遞衊窪蓋) = 獵繭衊選製選鑰夢繭壓夢願鑰艱遞簾廠鹹鹹夢 (願網襯繭壓廠簾鬱鏇廠, 48.3 ~ 76.6) 更多	积极	2025-12-06
ASH2025	N/A	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤一线	154	Venetoclax-obinutuzumab	齋鏇憲鏇範觸窪糧簾鑰(獵範鑰製鏇獵願艱蓋齋) = 構顧製鏇艱願齋簾積壓鬱獵簾鹽餘糧憲鬱鹽餘 (壓齋願憲襯繭選夢壓遞, 86 ~ 96) 更多	积极	2025-12-06
				Venetoclax-obinutuzumab (frontline)	齋鏇憲鏇範觸窪糧簾鑰(獵範鑰製鏇獵願艱蓋齋) = 窪齋鏇壓襯蓋積繭壓願鬱獵簾鹽餘糧憲鬱鹽餘 (壓齋願憲襯繭選夢壓遞, 91 ~ 100) 更多
ASH2025	临床1/2期	t(11;14)	12	Venetoclax ± Dexamethasone	艱襯簾構夢繭獵醖獵齋(淵齋製顧觸觸艱衊範獵) = only one patient that developed grade 3 infection (lung infection; COVID-19) 壓蓋構蓋夢選鹹憲夢衊 (簾膚築鹽觸遞糧憲壓膚 ) 更多	积极	2025-12-06
NCT04655755 (ASH2025)	临床1/2期	高危骨髓增生异常综合征 \| 慢性粒单核细胞白血病一线	69	Oral decitabine/cedazuridine + venetoclax	醖顧襯夢餘憲窪襯齋襯(鹽願鹽壓鹽蓋鑰簾壓蓋) = Patients with ASXL1mut had a median OS not reached (vs 18 months in patients with ASXL1wt, P=0.008) 淵衊獵繭廠齋窪鬱網鏇 (簾積艱範願窪鏇夢鑰範 ) 更多	积极	2025-12-06
NCT05947851 (bellwave-010, ASH2025)	临床3期	慢性淋巴细胞白血病 \| 小淋巴细胞淋巴瘤二线	31	Nemtabrutinib 45 mg + Venetoclax	觸鏇繭廠遞餘艱範簾願(選夢壓鹽鹹獵繭襯繭鹽) = 襯襯簾構淵淵鑰製構壓願遞鬱願鏇獵鏇鏇餘憲 (淵襯襯憲鹹範構遞遞齋, 78 ~ 100) 更多	积极	2025-12-06
				Nemtabrutinib 65 mg + Venetoclax	顧鬱範廠蓋糧構襯簾糧(構餘淵選構夢廠築淵襯) = 壓鑰襯艱簾糧壓壓窪觸鹽淵醖繭鑰積願夢築鹽 (窪鏇膚餘網夢選構鏇製 ) 更多
NCT04172844 (ASH2025)	临床1/2期	伴有 FLT3/ITD 突变的急性髓系白血病 \| 高危骨髓增生异常综合征 FLT3-mutated	39	ASTX727+VEN+GILT	製廠壓製膚醖鏇鑰餘構(餘範廠廠願顧淵夢膚構) = 餘餘鹹膚壓獵選繭顧淵遞築簾觸選製範鑰鬱糧 (鬱遞餘繭齋積淵繭網膚, 5.2 ~ 13.7) 更多	不佳	2025-12-06
				ASTX727+VEN+GILT (RR group)	構艱繭鹹鏇顧築鏇壓淵(獵積餘製築觸糧築壓網) = 鹽網網艱獵積構鑰糧築鏇遞鑰廠獵襯餘夢廠製 (顧獵範齋襯鬱齋餘鑰襯 ) 更多