奈拉滨(Nelarabine) - 药物靶点：POLA1_在研适应症：T细胞急性淋巴细胞白血病/淋巴瘤，前体T淋巴细胞白血病淋巴瘤，复发性T淋巴母细胞淋巴瘤_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Arranon、Atriance、506-U78

+ [19]

靶点

POLA1

作用方式

抑制剂

作用机制

POLA1抑制剂(DNA聚合酶α亚基抑制剂)

治疗领域

肿瘤免疫系统疾病血液及淋巴系统疾病+ [1]

在研适应症

T细胞急性淋巴细胞白血病/淋巴瘤前体T淋巴细胞白血病淋巴瘤复发性T淋巴母细胞淋巴瘤+ [3]

非在研适应症

成人T细胞白血病/淋巴瘤间变性大细胞淋巴瘤CD30-Positive recurrent or refractory Cutaneous T-Cell Lymphoma+ [16]

原研机构

GSK Plc

在研机构

正大天晴药业集团股份有限公司

正大天晴药业集团南京顺欣制药有限公司Sandoz Pharmaceuticals DD (Belarus)

+ [4]

非在研机构

Novartis AG

GSK Plc

National Institutes of Health

最高研发阶段批准上市

首次获批日期

美国 (2005-10-28),

前体T淋巴细胞白血病淋巴瘤

最高研发阶段(中国)临床3期

特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (美国)、孤儿药 (澳大利亚)

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结构/序列

分子式C11H15N5O5

InChIKeyIXOXBSCIXZEQEQ-UHTZMRCNSA-N

CAS号121032-29-9

关联

30

项与奈拉滨相关的临床试验

NCT06390319

/ Recruiting临床2期IIT

SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.
Primary Objective
* To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.
* To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.
Secondary Objectives
* To assess the event free and overall survival of patients treated with this therapy.
* To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.

开始日期2024-12-27

申办/合作机构

St. Jude Children's Research Hospital, Inc.

[+1]

NCT06210750

/ Withdrawn临床2期IIT

A Randomized Phase 2 Trial to Evaluate the Efficacy of BCL-2 Inhibitor Therapy With Chemotherapy Compared to Chemotherapy Alone in Adult Patients With Newly Diagnosed T-Cell ALL and T-Cell Lymphoblastic Lymphoma

This phase II trial tests the safety and effectiveness of giving chemotherapy with or without venetoclax and/or navitoclax for the treatment of patients with newly diagnosed T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL). Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Venetoclax and navitoclax are in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. They may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving chemotherapy with or without venetoclax and/or navitoclax may be effective treatments for patients with newly diagnosed T-ALL or T-LBL.

开始日期2024-08-09

申办/合作机构

National Cancer Institute

CTR20240655

/ Recruiting临床3期

奈拉滨注射液治疗儿童和成人难治或复发的T淋巴母细胞白血病（T-ALL）和T淋巴母细胞淋巴瘤（T-LBL）患者的有效性及安全性研究

评估儿童和成人难治或复发的T-ALL和T-LBL患者，接受奈拉滨注射液治疗后IRC评估的2周期内的复合完全缓解率（CCR）。

开始日期2024-05-07

申办/合作机构

正大天晴药业集团南京顺欣制药有限公司

100 项与奈拉滨相关的临床结果

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100 项与奈拉滨相关的转化医学

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100 项与奈拉滨相关的专利（医药）

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521

项与奈拉滨相关的文献（医药）

2025-03-04·Expert Review of Clinical Pharmacology

Therapeutic drug monitoring in acute lymphoblastic leukemia–a deep dive into pharmacokinetics, -dynamics, and -genetics of antileukemic drugs

Review

作者: Rank, Cecilie Utke ; Kielsen, Katrine ; Schmiegelow, Kjeld ; Raja, Raheel ; Elitzur, Sarah ; Buhl Rasmussen, Anna S. ; Uhlving, Hilde Hylland ; Brigitha, Leiah J. ; Pontoppidan, Peter ; van der Sluis, Inge M. ; Dalhoff, Kim ; Toksvang, Linea N. ; Als-Nielsen, Bodil ; Brivio, Erica ; Andres-Jensen, Liv

INTRODUCTION:

Therapeutic drug monitoring (TDM) is important to optimize drug exposure and minimize toxicity for the individual patient.

AREAS COVERED:

This narrative review covers the pharmacokinetics (PK), -dynamics (PD) and -genetics of classic chemotherapeutic drugs used in frontline therapy for acute lymphoblastic leukemia (ALL), including anthracyclines, asparaginase, busulfan, cyclophosphamide, cytarabine, glucocorticoids, methotrexate, nelarabine, thiopurines, tyrosine kinase inhibitors, and vincristine. Furthermore, novel immunotherapies including blinatumomab, inotuzumab ozogamicin, and chimeric antigen receptor T-cells that are rapidly moving into frontline therapy are addressed. This review focuses on TDM already used in clinical practice as well as the unused potential and feasibility of TDM. Finally, important factors affecting PK/PD such as obesity and transition to adolescence and young adulthood are discussed.

EXPERT OPINION:

Investigation of TDM as standard of care for antileukemic agents is highly warranted to personalize curative yet toxic anticancer regimens within frontline ALL treatment. Some of the drugs have been used in ALL treatment regimens for decades, but a wide range of new compounds are being introduced, some like blinatumomab reaching standard-of-care designation. Not least, optimized drug efficacy and reduction of the risk of serious toxicities may render TDM implementation cost-effective.

2025-03-01·LEUKEMIA

Nelarabine in T-cell acute lymphoblastic leukemia: intracellular metabolism and molecular mode-of-action

Review

作者: Rudd, Sean G ; Hormann, Femke M

Abstract:

T-cell acute lymphoblastic leukemia (T-ALL) patients often have a poor 5-year event-free survival. The only T-ALL specific drug in clinical practice is nelarabine. A prodrug of the deoxyguanosine analog ara-G, nelarabine is a rationally designed agent selective for the treatment of T-cell malignancies. Originally approved for relapsed/refractory T-ALL, it is increasingly used in T-ALL therapy and is currently being evaluated in upfront treatment. Whilst the clinical use of nelarabine has been the topic of multiple review articles, a thorough overview of the preclinical data detailing the molecular underpinnings of its anti-leukemic activity is lacking, which is critical to inform mechanism-based use. Thus, in the present article we conducted a semi-systematic review of the literature and critically evaluated the preclinical knowledge on the molecular pharmacology of nelarabine. Whilst early studies identified ara-G triphosphate to be the principal active metabolite and nuclear DNA synthesis to be a key target, many fundamental questions remain that could inform upon future use of this therapy. These include the nature of nelarabine-induced DNA lesions and their repair, together with additional cellular targets of ara-G metabolites and their role in efficacy and toxicity. A critical avenue of research in need of development is investigation of nelarabine combination therapies, both in the context of current T-ALL chemotherapy regimens and with emerging anti-leukemic agents, and we highlight some areas to pursue. Altogether, we discuss what we can learn from the preclinical literature as a whole and present our view for future research regarding nelarabine treatment in T-ALL.

2025-02-24·Journal of Chemical Information and Modeling

Vertex-Edge-Weighted Molecular Graphs: A Study on Topological Indices and Their Relevance to Physicochemical Properties of Drugs Used in Cancer Treatment

Article

作者: Birgin, Kahraman ; Sorgun, Sezer

Quantitative structure-property relationship (QSPR) analysis plays a crucial role in predicting physicochemical properties and biological activities of pharmaceutical compounds, aiding in drug design and optimization. This study focuses on leveraging QSPR within the framework of vertex and edge-weighted (VEW) molecular graphs, exploring their significance in drug research. By examining 48 drugs used in the treatment of various cancers and their physicochemical properties, previous studies serve as a foundation for our research. Introducing a novel methodology for computing vertex and edge weights, we highlight the importance of considering atomic properties and interbond dynamics. Statistical analysis, employing linear regression models, reveals enhanced correlations between topological indices and the physicochemical properties of drugs. Comparison with previous studies on unweighted molecular graphs highlights the enhancements achieved with our approach.

30

项与奈拉滨相关的新闻（医药）

2025-03-17

·FiercePharma

Dr. Reddy’s, Sun Pharma and Zydus issue US recalls, citing failed specs and labeling issues

Multiple drugmakers have had to yank their products in the U.S. this year over manufacturing and quality concerns. A trio of drugmakers have issued separate recalls in the U.S. thanks to string of production flubs, including failed impurity and dissolution specifications and incorrect labelling of infusion bags.The companies behind the product pulls are Dr. Reddy’s Laboratories, Sun Pharma and Zydus Pharmaceuticals, all three of which hail from India. The drugmakers are recalling seizure treatments, painkillers and a chemotherapy drug, respectively, according to the FDA’s online enforcement report, which the regulator uses to catalogue recalls. In the case of Dr. Reddy’s, the company unveiled a voluntary recall on March 13 for one lot of 1,000 mg/100 ml single-dose levetiracetam infusion bags that had been shipped out across the U.S. in early November. The infusion bags from the suspect batch were incorrectly labeled as 500 mg/100 ml levetiracetam in 0.82% sodium chloride injection, while the aluminum overwrap packaging correctly identifies the product as levetiracetam in 0.75% sodium chloride injection 1,000 mg/100 ml, Dr. Reddy’s explained in its recall notice.Levetiracetam is typically used to treat certain types of seizures when patients are unable to take an oral medication. Although Dr. Reddy’s says there have so far been no reported safety events related to the product pull, patients receiving higher-than-expected doses of the drug by rapid intravenous infusion are at risk of “immediate and serious side effects,” including liver injury, respiratory depression and coma, the company explained. Sun Pharma, for its part, is recalling nearly 10,000 100 mg bottles of morphine sulfate extended-release tablets after the products failed to meet FDA dissolution specifications. The painkillers are part of lot AD16615, which was set to expire in July. The morphine sulfate tablets at issue were distributed nationwide, according to the FDA’s enforcement report.Sun initiated the Class II recall on Feb. 6. The tablets were manufactured by the Indian drugmaker’s subsidiary Ohm Laboratories in New Brunswick, New Jersey.Lastly, Zydus Pharmaceuticals initiated two separate Class II recalls on Feb. 13 covering a whopping 38,871 vials of the chemotherapy injection nelarabine, which were manufactured at the company’s Ahmedabad, India, production facility.The drugmaker issued the recall due to failed impurity and degradation specifications, the FDA’s enforcement report notes.The far-reaching product pull accounts for more than 20 lots of the chemotherapy med, which were set to expire as early as last month or as late as July 2026, depending on the specific batch. Multiple drugmakers have had to yank their products in the U.S. this year, with one recent recall yielding significant interest for its scope and treatment type.Earlier this month, Glenmark Pharma revealed it was recalling some 1.48 million bottles of the generic attention-deficit/hyperactivity disorder (ADHD) drug atomoxetine after detecting unacceptable levels of a possible carcinogen in the product.Atomoxetine—previously sold by Eli Lilly under the brand name Strattera—is a selective norepinephrine reuptake inhibitor (sNRI) independent of the stimulant-based offerings that make up the bulk of ADHD treatment.

上市批准

2024-12-06

·学术经纬

Cancer Discovery｜儿童急性T淋巴细胞白血病的临床特征与高危突变

撰文 | 尹彤责编 | 周叶斌急性T淋巴细胞白血病（T-ALL）是儿童最常见的血液系统肿瘤之一。其中γδ T-ALL是一个较少研究的亚型，其肿瘤细胞表面表达由γ链和δ链组成的T细胞受体（TCR），约占全部T-ALL病例的10%。既往研究提示，该亚型可能面临更差的治疗效果和更高的复发风险。由于缺乏大规模针对γδ T-ALL的研究，其临床特征和发病机制仍不清楚。虽然近年来通过基因组学研究取得了一些进展，但这些研究纳入的γδ T-ALL病例较少，且缺乏对非编码区等基因组特征的分析，因此亟需进行更全面、深入的研究。近日，以圣裘德儿童研究医院 Charles G. Mullighan 和 Hiroto Inaba 团队牵头的多国联合团队在 Cancer Discovery 发表了题为 Biologic and Clinical Analysis of Childhood Gamma Delta T-ALL Identifies LMO2/STAG2 Rearrangements as Extremely High Risk 的文章。该研究基于200例γδ T-ALL的临床和基因组数据，揭示了发病年龄<3岁、诱导治疗后MRD≥1%和STAG2/LMO2突变是儿童γδ T-ALL的高危因素，进而筛选了针对此类患者有效的治疗策略。本研究纳入了由13项临床研究组成的多国合作组的200例25岁以下的γδ T-ALL患者，以及1,067例根据治疗方案匹配的非γδ T-ALL对照病例。研究发现，γδ T-ALL患者总体上表现出较差的预后，诊断年龄更小，且治疗后的应答更差，表现为在诱导治疗和巩固治疗后都有更高的微小残留病变（measurable residual disease，MRD）水平，需要进行造血干细胞移植的比例更高，且原发病或治疗副作用造成的死亡率更高。诊断年龄小于3岁的γδ T-ALL患者，其5年无事件生存率（event-free survival，EFS）仅为33%，总生存率（overall survival，OS）仅为49%，显著低于诊断年龄≥3岁的γδ T-ALL患者或非γδ T-ALL患者。此外，诱导治疗结束时（end of induction，EOI），MRD≥1%的患者在所有年龄段的生存率均显著低于MRD<1%的患者。这些数据表明诊断年龄 <3岁和 EOI 时 MRD≥1% 是提示 γδ T-ALL 患儿不良预后的高危因素，因此这些高风险患者可能需要优化的治疗方案。此外，研究发现，γδ T-ALL患者的复发主要局限于骨髓（骨髓复发率高达91.3%），而非γδ T-ALL患者中枢神经系统复发更常见。研究设计和患者临床结局：（A）研究方案，（B）γδ T-ALL患者与非γδ T-ALL患者的生存率对比，（C/D）γδ T-ALL患者中诊断年龄和EOI时MRD水平对生存率的影响结合全基因组测序（whole genome sequencing，WGS）、RNA测序和HiChIP等技术，研究者对γδ T-ALL患者的基因变异进行了分型，并解析了突变导致的疾病机制。γδ T-ALL患者与非γδ T-ALL患者相比具有独特的基因型分布。STAG2/LMO2双突变是γδ T-ALL患者特征性变异之一，所有纳入研究的该亚型γδ T-ALL患儿的诊断年龄都小于3岁，且与其他类型患者相比生存期显著较短。进一步研究表明STAG2/LMO2双突变患者中最常见的变异类型是LMO2::STAG2重排，导致STAG2失活和LMO2过度激活。STAG2是黏着复合物（cohesin complex）的重要组分，参与染色质空间折叠以形成拓扑相关结构域（topologically associating domain，TAD），进而通过增强子-启动子相互作用调控基因正常表达。通过构建STAG2缺失和过表达的细胞模型，并进行RNA-seq和H3K27ac ChIP-seq分析，研究者证明了STAG2失活将导致TAD结构异常，严重破坏T细胞分化相关基因表达，导致白血病的发生。此外，研究还发现了其他γδ T-ALL特异性基因分型，如LMO2-γδ样、超二倍体T-ALL伴重现性染色体增加、TLX3重排和PICALM::MLLT10融合等，这些亚型γδ T-ALL患者具有各自不同的临床特征。 γδ T-ALL基因分型和临床特征：（A）参考所有T-ALL基因组数据对γδ T-ALL进行基因分型，（B）不同基因型在γδ T-ALL与非γδ T-ALL患者中的分布，（D）γδ T-ALL患者不同基因型与诊断年龄的关系，（E）不同基因型γδ T-ALL患者的生存曲线最后，研究者通过高通量药物筛选探索了潜在的治疗策略。PARP抑制剂talazoparib和组蛋白去乙酰化酶抑制剂vorinostat是对STAG2/LMO2 γδT-ALL细胞具有显著杀伤作用的药物，其中PARP抑制剂靶向STAG2失活造成的DNA复制缺陷，使双链DNA断裂积累并诱导细胞死亡。在患者来源的异种移植模型（PDX）中，talazoparib 和 vorinostat 都可以有效地抵抗肿瘤生长。其他有效的药物包括nelarabine和L-门冬酰胺酶等，这些药物都已经被用于T-ALL或其他肿瘤的临床研究或治疗。此发现为高风险的γδ T-ALL患儿提供了一种潜在的精准治疗策略。针对talazoparib（Tal）和vorinostat（Vor）的临床前试验表明两种药物均能够显著抑制PDX肿瘤细胞的生长总之，本研究首次全面探讨了儿童γδ T-ALL的临床特征和基因分型，并揭示了高危突变的致病机制及潜在的治疗策略。研究明确了诊断年龄和MRD水平对患者预后的关键作用，并揭示了高危患儿STAG2失活对染色质结构和基因表达具有深远影响。更重要的是，本研究提出了 PARP 抑制剂等可做为靶向 STAG2/LMO2 亚型的潜在治疗策略，这些成果加深了对儿童γδ T-ALL的认识，也为未来γδ T-ALL患儿的风险分层和个体化治疗开发提供了重要参考。撰文责编制作排版 | Sheila 校对 | uu 延伸阅读儿童T细胞急性淋巴细胞白血病的多组学分析竺晓凡/张英驰团队揭示儿童T-ALL癌细胞克隆演化模式及耐药新机制 *本文由深圳市拾玉儿童公益基金会“儿童肿瘤前沿”团队编译或约稿，文中图表均源引自文献原文。本文著作权归文章作者所有，欢迎个人转发分享，未经允许禁止转载，作者拥有所有法定权利，违者必究。如需转载，请留言或联系shiyu@curekids.cn。本文旨在分享儿童肿瘤科研前沿成果，不是治疗方案推荐。如需获得疾病治疗方案指导，请前往正规医院就诊。 ▼滑动查看更多▼ 原文摘要（Abstract） Acute lymphoblastic leukemia expressing the gamma delta T-cell receptor (γδ T-ALL) is a poorly understood disease. We studied 200 children with γδ T-ALL from 13 clinical study groups to understand the clinical and genetic features of this disease. We found age and genetic drivers were significantly associated with outcome. γδ T-ALL diagnosed in children under 3 years of age was extremely high-risk and enriched for genetic alterations that result in both LMO2 activation and STAG2 inactivation. Mechanistically, using patient samples and isogenic cell lines, we show that inactivation of STAG2 profoundly perturbs chromatin organization by altering enhancer-promoter looping, resulting in deregulation of gene expression associated with T-cell differentiation. High-throughput drug screening identified a vulnerability in DNA repair pathways arising from STAG2 inactivation, which can be targeted by poly(ADP-ribose) polymerase inhibition. These data provide a diagnostic framework for classification and risk stratification of pediatric γδ T-ALL. Significance: Patients with acute lymphoblastic leukemia expressing the gamma delta T-cell receptor under 3 years old or measurable residual disease ≥1% at end of induction showed dismal outcomes and should be classified as having high-risk disease. The STAG2/LMO2 subtype was enriched in this very young age group. STAG2 inactivation may perturb chromatin conformation and cell differentiation and confer vulnerability to poly(ADP-ribose) polymerase inhibition. DOI: 10.1158/2159-8290.CD-23-1452 👇点击此处，直达原文

细胞疗法临床结果免疫疗法临床研究信使RNA

2024-06-28

·BioSpace

Shorla Oncology Announces FDA Approval for TEPYLUTE, A Novel Formulation to Treat Breast and Ovarian Cancer

TEPYLUTE is a ready-to-dilute formulation of thiotepa that reduces preparation time and enables accurate dosing CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application (NDA) for TEPYLUTE, a ready-to-dilute formulation to treat breast and ovarian cancer in an easier to prepare, injectable product that enables dosing accuracy.1 ‘’This approval fulfills an unmet need by addressing the shortcomings and handling complexities of the current lyophilized powder formulation,” said Sharon Cunningham, Chief Executive Officer and Co-Founder of Shorla Oncology. “We have taken a vital oncology drug and made it easier for oncology clinics and hospitals to use, while also reducing medical personnel exposure to a hazardous drug.” TEPYLUTE, formerly SH-105, is the third FDA-approved drug for Shorla, and a significant milestone for the company as it seeks approval for several cancer-fighting drugs for the U.S. market. “The approval of TEPYLUTE represents an important milestone for Shorla as our first in-house developed NDA,” said Orlaith Ryan, Chief Technical Officer and Co-Founder of Shorla Oncology. TEPYLUTE is a liquid form of a well-established, standard of care oncology drug, thiotepa. The new formulation eliminates the need for complex and time-consuming reconstitution. It provides consistent dosing accuracy and allows for “just in time” preparation.2 “Among TEPYLUTE’s many benefits, it removes the necessity to reconstitute which can introduce additional risks of drug preparation errors,” emphasized Rayna Herman, Chief Commercial Officer. “We look forward to providing an update on our launch plans for TEPYLUTE in the near future.” The American Cancer Society estimates that more than 300,000 women will be diagnosed with breast cancer in the U.S in 2024.3 About 19,680 women will be diagnosed with ovarian cancer in the United States.4 Shorla Oncology is currently marketing two products with a robust pipeline including SH-201, the first palatable oral liquid treatment for certain forms of leukemia and other cancers. In April, the company announced the FDA had accepted SH-201 for an NDA review with an expected action date of November 30, 2024. About Shorla Oncology Shorla Oncology is a privately- held, U.S. and Ireland- based commercial stage specialty pharmaceutical company established by Sharon Cunningham and Orlaith Ryan. The company has an advanced pipeline of innovative oncology drugs for orphan and pediatric cancers. Shorla is focused on indications where existing treatments are limited, in shortage or the drug applications are inadequate for the target population. The company’s growing portfolio brings accessible, affordable and life-saving treatments to patients, delivering a major contribution to patient care. Shorla currently markets two products, Nelarabine for the treatment of T-cell Leukemia and JYLAMVO for the treatment of acute lymphoblastic leukemia and other indications. For further information, please visit ________________________ 1 Carausu M, Carton M, Darlix A, Pasquier D, Leheurteur M, Debled M, Mouret-Reynier MA, Goncalves A, Dalenc F, Verret B, Campone M. Breast cancer patients treated with intrathecal therapy for leptomeningeal metastases in a large real-life database. ESMO Open 6: 100150. 1 Reinhardt H, Otte P, Eggleton AG, Ruch M, Wöhrl S, Ajayi S, Duyster J, Jung M, Hug MJ, Engelhardt M. Avoiding chemotherapy prescribing errors: analysis and innovative strategies. Cancer. 2019 May 1;125(9):1547-57. 2 TEPYLUTE Prescribing information and data on Shorla Oncology. 3 Breast Cancer Statistics | How Common Is Breast Cancer? | American Cancer Society, Accessed June 27, 2024 4 Ovarian Cancer Statistics | How Common is Ovarian Cancer | American Cancer Society, Accessed June 27, 2024

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100 项与奈拉滨相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D05134	奈拉滨	L01BB07	DB01280

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
T细胞急性淋巴细胞白血病/淋巴瘤	日本	Sandoz Pharmaceuticals AG	2007-10-19
前体T淋巴细胞白血病淋巴瘤	美国	Sandoz, Inc.	2005-10-28

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
复发性T淋巴母细胞淋巴瘤	临床3期	中国	正大天晴药业集团股份有限公司	2024-05-01
难治性 T 急性淋巴细胞白血病	临床3期	中国	正大天晴药业集团股份有限公司	2024-05-01
T细胞急性淋巴细胞白血病复发	临床2期	美国	Novartis AG	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	美国	GSK Plc	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	澳大利亚	Novartis AG	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	澳大利亚	GSK Plc	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	奥地利	Novartis AG	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	奥地利	GSK Plc	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	加拿大	GSK Plc	2010-06-01
T细胞急性淋巴细胞白血病复发	临床2期	加拿大	Novartis AG	2010-06-01

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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


NCT02619630 (GRAALL-2014/T, ASH2023)	临床2期	前体T淋巴细胞白血病淋巴瘤巩固	325	Nelarabine	醖齋獵繭製淵鹽繭鬱餘(繭壓鏇繭遞餘鹹壓鹽簾) = 鹹顧餘繭憲範繭網繭餘製壓夢夢窪鬱網鏇遞窪 (壓觸醖壓餘網夢廠糧膚, 20 ~ 37) 更多	-	2023-12-11
ASH2023	N/A	前体T淋巴细胞白血病淋巴瘤	133	Nelarabine (NEL)	糧繭構築餘範鬱淵淵簾(鑰願築壓鬱構顧鹹觸範) = 窪夢蓋願簾夢淵簾窪顧繭遞膚壓顧壓壓艱醖餘 (範繭製製鹽餘鑰鑰窪築 )	-	2023-12-11
				Pegylated Asparginase (PEG)	糧繭構築餘範鬱淵淵簾(鑰願築壓鬱構顧鹹觸範) = 鬱糧窪簾衊鹽遞廠餘夢繭遞膚壓顧壓壓艱醖餘 (範繭製製鹽餘鑰鑰窪築 )
NCT02763384 (CTgov)	临床2期	难治性 T 急性淋巴细胞白血病 \| 淋巴母细胞淋巴瘤	12	BL-8040+Nelarabine	憲選鹹淵遞憲範簾蓋鏇 = 遞願鹹觸遞壓餘膚簾蓋遞鏇醖醖繭鹽顧襯襯齋 (齋獵齋窪選構遞遞製鹽, 膚鑰願鑰淵構夢網鑰範 ~ 獵鏇願繭衊夢艱壓夢淵) 更多	-	2023-10-31
NCT01094860 (Pubmed)	临床1期	肿瘤	-	Nelarabine	網簾鹹艱壓鹽網顧餘夢(鹹醖積網壓築窪鹽蓋選) = 顧繭醖製艱簾築蓋鬱鏇構觸鹽鏇範窪遞鹽鹹壓 (齋網憲積艱鑰夢繭廠蓋 ) 更多	-	2022-11-29
EHA2022	N/A	T细胞急性淋巴细胞白血病/淋巴瘤	120	HyperCVAD + Nelarabine	築繭窪餘顧積夢願衊齋(鏇齋獵鬱製齋鹽淵鹹範) = elevated liver enzymes in 25 pts (21%) 餘築鏇醖製鏇鹽遞餘襯 (觸遞醖憲膚繭選齋獵鑰 ) 更多	-	2022-05-12
				HyperCVAD + Nelarabine + PEGylated Asparaginase
NCT00501826 (ASH 12020 \| ASH 22020) 人工标引	临床2期	前体T淋巴细胞白血病淋巴瘤 \| 复发性T淋巴母细胞淋巴瘤一线	96	Peg-Asparaginase+Nelarabine	膚艱鹹築艱鏇選構艱齋(願簾鹹網網繭衊襯選襯) = 鹹顧醖願積淵顧願廠壓願製窪構壓糧醖觸顧顧 (襯構蓋窪選齋網憲壓繭 ) 更多	积极	2020-11-05
				Peg-Asparaginase+Nelarabine (T-ALL)	鏇簾夢顧艱壓觸鏇觸顧(願餘範觸觸願網簾選顧) = 艱繭鏇壓鑰願簾繭醖願網醖淵夢獵願壓襯淵壓 (構廠鹽壓顧觸夢選艱壓 )
NCT00408005 (AALL0434, Pubmed \| J Urol \| J Clin Oncol) 人工标引	临床3期	前体T淋巴细胞白血病淋巴瘤	659	Berlin-Frankfurt-Muenster +Nelarabine	廠壓網窪廠窪築獵構廠(糧顧簾壓蓋遞鏇憲願餘) = 繭鏇選窪窪糧鬱遞鹽齋鹽選艱醖壓選淵餘蓋艱 (鹹鬱夢齋膚願築糧構簾, 2.4)	优效	2020-10-01
				Berlin-Frankfurt-Muenster	廠壓網窪廠窪築獵構廠(糧顧簾壓蓋遞鏇憲願餘) = 積醖蓋膚選網積淵積構鹽選艱醖壓選淵餘蓋艱 (鹹鬱夢齋膚願築糧構簾, 2.7)
NCT00981799 (CTgov)	临床1/2期	复发性T淋巴母细胞淋巴瘤 \| T细胞急性淋巴细胞白血病复发	23	Etoposide+cyclophosphamide+Filgrastim+Nelarabine+Methotrexate (Nelarabine Dose Level 1)	遞簾壓糧築願遞齋蓋廠 = 網觸網築鬱夢製鹹鹹醖淵鏇蓋鏇襯鬱鑰鑰餘鏇 (遞獵衊襯遞鹹壓蓋廠窪, 遞鏇膚淵鹽夢築範鏇衊 ~ 襯範廠廠淵築鬱繭鑰艱) 更多	-	2020-10-01
				Etoposide+cyclophosphamide+Filgrastim+Nelarabine+Methotrexate (Nelarabine Dose Level 2)	遞簾壓糧築願遞齋蓋廠 = 築製觸醖窪繭顧觸築繭淵鏇蓋鏇襯鬱鑰鑰餘鏇 (遞獵衊襯遞鹹壓蓋廠窪, 積鏇餘窪顧鏇鑰願製構 ~ 鬱廠築範衊餘繭網願觸) 更多
EHA2019	临床4期	T细胞急性淋巴细胞白血病/淋巴瘤	118	Nelarabine	鏇願獵鏇齋願蓋齋蓋壓(鑰積獵夢齋遞鑰築網鏇) = 鏇膚糧顧淵壓築築鹽鑰鑰積糧膚醖廠獵觸鑰製 (觸遞夢淵鏇鹹顧鑰齋鏇 ) 更多	-	2019-06-16
EHA2019	N/A	前体T淋巴细胞白血病淋巴瘤	9	Nelarabine	鬱艱餘簾憲積窪網積觸(遞觸鹽觸鬱蓋糧齋壓淵) = 鹽蓋蓋淵膚夢衊鏇艱顧築齋繭顧糧築窪窪範遞 (願選顧繭艱膚鏇齋鹹遞 ) 更多	-	2019-05-16