GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma

Primary Objectives:
To estimate the percent of participants who achieve a best response of complete response by the end of the PRV combination therapy in the induction therapy phase in patients with previously untreated MCL.

开始日期2025-12-01

申办/合作机构

The University of Texas MD Anderson Cancer Center

NCT06763341

/ Not yet recruiting临床1期IIT

A Phase 1/1b Study of AOH1996 Alone or in Combination With the BCL-2 Inhibitor Venetoclax +/- Azacitidine in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This phase I trial tests safety, side effects, and best dose of AOH1996 alone or in combination with venetoclax with or without azacitidine for the treatment of patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or AML that has not responded to previous treatment (refractory). AOH1996 is in a class of medications called PCNA inhibitors. It inhibits cancer growth and induces deoxyribonucleic acid (DNA) damage. This may help keep cancer cells from growing and damage cancer cell DNA. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking BCL-2, a protein needed for cancer cell survival. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells in the bone marrow. Giving AOH1996 alone or in combination with venetoclax with or without azacitidine may be safe, tolerable and/or effective in treating patients with AML.

开始日期2025-08-16

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06644183

/ Not yet recruiting临床1/2期IIT

A Phase 1/2, Open Label, Study of Roginolisib (IOA-244), an Orally Bioavailable, Selective PI3Kδ Inhibitor in Patients With Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) in Combination With Venetoclax and Rituximab

This research study will test the safety and anticancer activity of the combination of three drugs (Roginolisib, Venetoclax, and Rituximab) for participants with relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
The names of the study drugs involved in this study are:
* Roginolisib (a novel type of PI3-kinase delta inhibitor)
* Venetoclax (a type of B-cell lymphoma 2 inhibitor)
* Rituximab (a type of monoclonal antibody)

开始日期2025-04-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

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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3,566

项与维奈克拉相关的文献（医药）

2025-12-31·Hematology

Identification of t(X;1)(q28;q21) generating a novel GATAD2B::MTCP1 gene fusion in CMML and its persistence during progression to AML

Article

作者: Chen, Yu ; Zhu, Yi-yan ; Liu, Yi-zi ; Hou, Chun-xiao ; Zhang, Zhi-yu ; Chen, Su-ning ; Wang, Qian ; Zhang, Feng-hong

OBJECTIVE:

Hematological malignancies often involve chromosomal translocations and fusion genes that drive disease progression. While MTCP1 is well-known in T-cell prolymphocytic leukemia (T-PLL), its role in myeloid neoplasms is less understood. This report presents the first identification of the t(X;1)(q28;q21) translocation leading to the GATAD2B::MTCP1 fusion in acute myeloid leukemia (AML) transformed from chronic myelomonocytic leukemia (CMML).

METHODS:

The karyotypes were described according to the International System for Human Cytogenetic Nomenclature 2009. We performed targeted next-generation sequencing (NGS) on a panel of 172 genes commonly mutated in hematological malignancies (Supplemental Table 1), using an Illumina platform. RNA sequencing was conducted on total RNA extracted from bone marrow, also using the Illumina platform. The GATAD2B::MTCP1 fusion gene was confirmed by reverse transcription-polymerase chain reaction (RT-PCR) and Sanger sequencing, with specific primers for the fusion transcript (GATAD2B-F: CCTCTTTTTTTCGACGCC; MTCP1-R: ACTGAGCACAACACTTACGC).

RESULTS:

The GATAD2B::MTCP1 fusion results from a breakpoint on 1q21 within GATAD2B exon 1 and Xq28 within MTCP1 exon 2. The patient with the GATAD2B::MTCP1 fusion exhibited disease progression from CMML to AML. Despite achieving initial remission with venetoclax-based therapy and allo-HSCT, the patient relapsed and died.

CONCLUSIONS:

We propose that the GATAD2B::MTCP1 fusion upregulates MTCP1 expression rather than generating a fusion protein, thereby contributing to transformation and relapse in AML. Further investigations are needed to elucidate the precise role of this fusion event in myeloid malignancies.

2025-12-01·Blood Research

Relative efficacy of systemic treatments for patients with relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis according to 17p deletion/TP53 mutations

Article

作者: Lim, Joo Han ; Kim, Jinchul ; Lee, Moon Hee ; Cho, Jinhyun

Abstract:

Purpose:

This network meta-analysis aimed to evaluate the relative efficacy of systemic treatments in patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL), focusing on key genetic mutations, specifically the 17p deletion and TP53 mutations.

Methods:

We conducted a systematic literature review to identify all publicly available randomized controlled trials (RCTs) using PubMed, EMBASE, the Cochrane database, and meeting abstracts published through December 2023. A Bayesian network meta-analysis was performed to estimate the hazard ratios (HRs) for progression-free survival (PFS) with 95% confidence intervals (CIs) and to determine the ranking of the included regimens.

Results:

Twelve trials involving 4,437 patients and 13 treatment options were included in the meta-analysis. Venetoclax plus rituximab and zanubrutinib emerged as the most effective treatments for the overall R/R CLL population, showing the lowest PFS HR (HR 0.62, 95% CI 0.32–1.20 and HR 0.65, 95% CI 0.49–0.86, respectively) versus ibrutinib, and were ranked as the best agent (surface under the cumulative ranking curve [SUCRA] value of both 90%, respectively) among the included drugs. In the 17p deletion/TP53 mutation subgroup, zanubrutinib demonstrated the most favorable efficacy (HR 0.52, 95% CI 0.31–0.88 versus ibrutinib) with the highest SUCRA value (97%). In patients without these mutations, venetoclax plus rituximab was the most effective (HR 0.49, 95% CI 0.26–0.94 versus ibrutinib) with a SUCRA value of 94%.

Conclusion:

Our findings highlight the superior efficacy of venetoclax plus rituximab and zanubrutinib for treating R/R CLL and confirm that the role of each regimen may vary depending on the clinically significant mutations.

2025-12-01·CANCER CHEMOTHERAPY AND PHARMACOLOGY

Pharmacokinetic analysis of crushed venetoclax tablets combined with azacitizine for recurrent pediatric acute myeloid leukemia (AML)

Article

作者: Yasu, Takeo ; Yuza, Yuki ; Makimoto, Atsushi ; Matsui, Motohiro

BACKGROUND:

The efficacy of a combination therapy consisting of venetoclax (VEN) and azacytidine (AZA) for newly diagnosed acute myeloid leukemia (AML) has been confirmed in elderly patients. However, the clinical data on VEN for pediatric AML are limited. A combination therapy consisting of crushed VEN tablets and AZA (VEN/AZA) was administered to two children with recurrent AML. The pharmacokinetics of VEN were then analysed.

CASE PRESENTATION:

[Patient 1] A 1-year-old, male patient who experienced an AML relapse following an allogeneic hematopoietic stem cell transplantation received three courses of VEN/AZA. At the initial dosage of VEN (8 mg/kg), the minimum plasma concentration (C_min) was only 0.44 µg/ml, which was far less than the optimal C_min of 1.2 µg/ml. Subsequent dose-escalation to 10 mg/kg only achieved C_min 0.42 µg/ml. [Patient 2] A 3-year-old, female patient in whom infantile acute lymphoblastic leukemia was originally diagnosed experienced a recurrence in the form of AML after lineage-switching. Three courses of VEN/AZA were administered with the same therapeutic drug monitoring as in Case 1. The C_min of VEN was 0.15 µg/ml at 8 mg/kg. Afterwards, voriconazole 16 mg/kg/day was begun for a concomitant fungal infection together with VEN 2 mg/kg. This combination finally achieved C_min 1.14 µg/ml probably through CYP3A4 inhibition by voriconazole. In terms of safety, only grade 4 hematological adverse events were observed in both patients. In terms of efficacy, patient 1 and patient 2 achieved stable disease status for two months and six months, respectively.

CONCLUSION:

Pediatric patients may scarcely achieve effective plasma concentration of VEN when crushed tablets are used at the same dosage as in adults.

1,218

项与维奈克拉相关的新闻（医药）

2025-01-19

·药明康德

疾病控制率达90%的创新疗法；靶点作用率达95%的PI3Kα共价抑制剂…… | 一周盘点

▎药明康德内容团队编辑本期看点 1. 多肽偶联药物（PDC）AVA6000在治疗唾液腺癌（SGC）患者的1a期临床试验中获得积极数据，疾病控制率（DCR）达90%。 2. 蛋白降解药物BHV-1400在首个人体临床试验中获得积极结果，在最低剂量下只需一次注射，就可在4小时内将致病抗体水平降低60%。 3. PI3Kα共价抑制剂TOS-358在一项1期临床试验中对PI3Kα的靶点作用率达到95%。药明康德内容团队整理 AVA6000：公布1期临床试验数据 Avacta Therapeutics公司宣布，其在研多肽偶联药物AVA6000在治疗唾液腺癌患者的1a期临床试验中获得积极数据。唾液腺癌是一种在转移性阶段尚无标准治疗方案的疾病。AVA6000是Avacta研发管线中的首个多肽偶联药物，由阿霉素（doxorubicin）与Avacta专有的pre|CISION多肽偶联而成，该多肽可在肿瘤微环境中由成纤维细胞激活蛋白-α（FAP）特异性切割。FAP在大多数实体瘤中，与健康组织相比表达水平显著升高。Avacta的多肽偶联药物利用这一特征在肿瘤微环境中特异性释放活性药物，从而降低系统暴露和毒性，为患者提供最佳治疗效果。此次公布的数据显示，AVA6000在唾液腺癌患者中实现了显著且具有临床意义的肿瘤缩小。在接受250 mg/m²及以上剂量治疗的10名唾液腺癌患者中，DCR达90%，5名患者肿瘤显著缩小，其中包括一例部分缓解（PR，肿瘤缩小45%）和四例轻微缓解（MR，肿瘤缩小10%-19.5%）。安全性方面，在每两周一次和每三周一次两个剂量组中，AVA6000的耐受性良好，与常规剂量阿霉素相比，其血液学和心脏毒性明显降低。目前尚未在任一剂量组中确定最大耐受剂量（MTD）。 BHV-1400：公布1期临床试验的初步数据 Biohaven公司公布了其蛋白降解药物管线中的双特异性分子BHV-1400的最新结果。BHV-1400是一款基于耶鲁大学（Yale University）的MoDE技术的双特异性分子，它的一端与半乳糖缺乏型IgA1（Gd-IgA1）抗体结合，另一端与肝细胞表面的去唾液酸糖蛋白受体（ASGPR）结合。ASGPR介导肝细胞通过内吞过程，将靶点蛋白吞入细胞内进行降解。IgA肾病是由于Gd-IgA1的过度生产造成的，BHV-1400通过降低血液循环和肾脏中的Gd-IgA1水平，有望从根源治疗IgA肾病。此次公布的初步数据显示，BHV-1400在首个人体临床试验中获得积极结果，在最低剂量下只需一次注射，就可在4小时内将致病抗体水平降低60%。在某些患者中，观察到在8小时内将Gd-IgA1水平降低70%。此外，Gd-IgA1水平的降低在单次注射后可维持数天。安全性方面，迄今为止，BHV-1400在1期临床试验中的安全性和耐受性良好，未发现具有临床意义的先天和适应性免疫力的变化，并且未观察到剂量限制性毒性。这项研究将继续提高BHV-1400的剂量，探索降低Gd-IgA1水平的范围。基于该研究的积极结果，该公司还计划直接启动关键性临床试验，评估BHV-1400治疗IgA肾病的疗效和安全性。 ▲BHV-1400快速降低Gd-IgA1水平（图片来源：Biohaven公司官网） TOS-358：公布1期临床试验数据 Totus Medicines公司公布了其在研PI3Kα共价抑制剂TOS-358的1期临床试验数据。TOS-358是一款具高度特异性、强效的PI3Kα抑制剂，可在临床前模型中实现近100%的PI3Kα抑制，诱导带有PI3Kα突变的异种移植实体瘤的细胞死亡，包含结直肠癌、肺癌、乳腺癌、卵巢癌、食管癌、头颈癌，且几乎没有观察到非靶向抑制。此次公布的研究结果表明，TOS-358在低至5 mg每日两次（BID）的剂量下具有泛突变临床活性，对PI3Kα的靶点作用率达到95%，且观察到未经确认的完全缓解（CR）。安全性方面，未报道3/4级毒性。值得注意的是，几名接受给药的患者现在已超过6个月未发生进展。在成功完成1期剂量递增研究后，该公司现在启动了一项扩展研究，针对乳腺癌、子宫内膜癌、尿路上皮癌和头颈癌。 ORIC-944：公布1b期联合治疗试验数据 ORIC Pharmaceuticals公司公布了其选择性PRC2别构抑制剂ORIC-944联用阿帕鲁胺治疗转移性去势抵抗性前列腺癌（mCRPC）的1b期临床试验数据。截至2024年12月10日的数据，6例患者中有3例达到确认的PSA50应答（即PSA水平降低50%），其中2例达到确认的PSA90应答。所有PSA应答均维持≥12周，其中包括一例在38周时仍然持续的、确认的PSA90应答。 Soquelitinib：公布1期临床试验的中期数据 Corvus Pharmaceuticals公司公布了其小分子白细胞介素-2诱导的T细胞激酶（ITK）抑制剂soquelitinib用于治疗中度至重度特应性皮炎的1期临床试验的新中期数据。ITK是一种主要表达于T细胞中的酶，在T细胞和自然杀伤（NK）细胞的免疫功能中起重要作用。通过抑制ITK，soquelitinib有望抑制自身免疫和炎症反应。此次公布的结果显示，与安慰剂相比，soquelitinib治疗组在研究者总体评估（IGA）评分为0/1（皮肤症状清除或几乎清除）和湿疹面积和严重度指数较基线减少75%（EASI 75）这些临床终点方面显示出良好的疗效特征。在soquelitinib组的19例患者中，26%的患者达到IGA 0/1，37%的患者达到EASI 75。在安慰剂组的7例患者中，没有人达到IGA 0/1，也没有人达到EASI 75。安全性方面，未观察到明显的安全问题，也未发现临床上显著的实验室检测异常。 ▲治疗第28天达到终点IGA 0/1、EASI 75的患者占比（图片来源：参考资料[4]） ISM5411：公布两项1期临床试验数据英矽智能（Insilico Medicine）公司宣布，其自主研发的候选药物ISM5411已完成在澳大利亚和中国开展的两项1期研究，并取得了积极的初步结果。ISM5411是一种潜在用于治疗炎症性肠病（IBD）的小分子抑制剂，靶向PHD1/2靶点且具有新颖的分子结构，该候选药物设计和优化得到了英矽智能生成化学平台Chemistry42的支持。此次公布的结果显示，在所有剂量组中ISM5411均表现出良好的安全性和耐受性，并初步验证了肠道限制性药代动力学（PK）特征。基于1期临床试验的积极结果，英矽智能预计将于2025年下半年启动一项评估ISM5411在活动性溃疡性结肠炎患者中的2期临床试验。 MBX 1416：公布1期临床试验数据 MBX Biosciences公司公布了在健康成年受试者中开展的MBX 1416单剂量递增和多剂量递增临床试验的积极结果。MBX 1416是一种长效胰高血糖素样肽1（GLP-1）受体拮抗剂，用于治疗减肥后的低血糖症（PBH）。MBX 1416采用MBX公司新颖、专有的精准内分泌肽（PEP）平台设计，旨在防止PBH患者发生严重低血糖，使他们能够过上更健康、更独立的生活。此次公布的结果显示，MBX 1416通常安全性和耐受性良好，并且具有良好的药代动力学特征，支持每周一次给药。基于这些结果，该公司计划于2025年下半年在PBH患者中启动一项2期研究，以进一步优化剂量。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料（可上下滑动查看） [1] Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers. Retrieved January 16, 2025, from https://www.globenewswire.com/news-release/2025/01/16/3010665/0/en/Avacta-Announces-Positive-New-Data-from-the-AVA6000-Phase-1-trial-Demonstrating-Clinically-Meaningful-Tumor-Shrinkage-in-Patients-with-Salivary-Gland-Cancers.html [2] Biohaven Highlights Portfolio Progress, Innovation, and Anticipated Milestones at the 43rd Annual J.P. Morgan Healthcare Conference; Reports Positive Degrader Data with Rapid, Deep, and Selective Lowering of Galactose-Deficient IgA1 with Next Generation Potential Therapy for IgA Nephropathy. Retrieved January 14, 2025, from https://www.prnewswire.com/news-releases/biohaven-highlights-portfolio-progress-innovation-and-anticipated-milestones-at-the-43rd-annual-jp-morgan-healthcare-conference-reports-positive-degrader-data-with-rapid-deep-and-selective-lowering-of-galactose-deficient-ig-302349336.html [3] Totus Medicines Announces Successful Completion of a Phase 1 Dose-Escalation Study and Initiation of an Expansion Trial Evaluating TOS-358, a Covalent PI3Ka Selective Therapy for the Treatment of Select Solid Tumors and Appoints Zelanna Goldberg as Chief Medical Officer. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007658/0/en/Totus-Medicines-Announces-Successful-Completion-of-a-Phase-1-Dose-Escalation-Study-and-Initiation-of-an-Expansion-Trial-Evaluating-TOS-358-a-Covalent-PI3Ka-Selective-Therapy-for-th.html [4] Corvus Pharmaceuticals Announces Data from Cohort 2 of Placebo-Controlled Phase 1 Clinical Trial of Soquelitinib for Atopic Dermatitis. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008374/0/en/Corvus-Pharmaceuticals-Announces-Data-from-Cohort-2-of-Placebo-Controlled-Phase-1-Clinical-Trial-of-Soquelitinib-for-Atopic-Dermatitis.html [5] ORIC® Pharmaceuticals Provides Early Phase 1b Combination Data for ORIC-944, Operational Highlights for 2024, and Anticipated Upcoming Milestones. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008495/0/en/ORIC-Pharmaceuticals-Provides-Early-Phase-1b-Combination-Data-for-ORIC-944-Operational-Highlights-for-2024-and-Anticipated-Upcoming-Milestones.html [6] 英矽智能公布炎症性肠病药物ISM5411两项I期临床试验的积极结果. Retrieved January 17, 2025, from https://www.prnasia.com/story/474986-1.shtml [7] MBX Biosciences Announces Positive Phase 1 Topline Results for MBX 1416 for the Treatment of Post-bariatric Hypoglycemia. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/07/3005223/0/en/MBX-Biosciences-Announces-Positive-Phase-1-Topline-Results-for-MBX-1416-for-the-Treatment-of-Post-bariatric-Hypoglycemia.html [8] Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007493/0/en/Mersana-Therapeutics-Announces-Positive-Initial-Clinical-Data-from-Phase-1-Clinical-Trial-of-Emiltatug-Ledadotin-XMT-1660-Initiation-of-Expansion-in-Triple-Negative-Breast-Cancer.html [9] Axcynsis Therapeutics Receives FDA Clearance for IND Application of AT03-65, a Differentiated CLDN6-Targeting ADC, Powered by AxcynDOT™ Technology. Retrieved January 17, 2025, from https://www.prnewswire.com/news-releases/axcynsis-therapeutics-receives-fda-clearance-for-ind-application-of-at03-65-a-differentiated-cldn6-targeting-adc-powered-by-axcyndot-technology-302350114.html [10] Ocugen, Inc. Announces Positive 2-Year Data Across Multiple Mutations from Phase 1/2 Clinical Trial of OCU400 —A Novel Modifier Gene Therapy for Retinitis Pigmentosa. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008252/0/en/Ocugen-Inc-Announces-Positive-2-Year-Data-Across-Multiple-Mutations-from-Phase-1-2-Clinical-Trial-of-OCU400-A-Novel-Modifier-Gene-Therapy-for-Retinitis-Pigmentosa.html [11] Verismo Therapeutics Announces First Patient Infused in Phase 1 CELESTIAL-301 Clinical Trial of SynKIR™-310. Retrieved January 17, 2025, from https://www.prnewswire.com/news-releases/verismo-therapeutics-announces-first-patient-infused-in-phase-1-celestial-301-clinical-trial-of-synkir-310-302347464.html [12] Caribou Biosciences Initiates the CB-010 GALLOP Phase 1 Trial in Lupus and Provides Outlook for Multiple Clinical Datasets in 2025. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008079/0/en/Caribou-Biosciences-Initiates-the-CB-010-GALLOP-Phase-1-Trial-in-Lupus-and-Provides-Outlook-for-Multiple-Clinical-Datasets-in-2025.html [13] Arcturus Therapeutics Announces Initiation of Phase 1 H5N1 Flu Vaccine Trial. Retrieved January 17, 2025, from https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-initiation-phase-1-h5n1-flu [14] Korro Bio Announces Dosing of First Participants in REWRITE Phase 1/2a Study of KRRO-110 for Alpha-1 Antitrypsin Deficiency and Provides Pipeline Update. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/13/3008445/0/en/Korro-Bio-Announces-Dosing-of-First-Participants-in-REWRITE-Phase-1-2a-Study-of-KRRO-110-for-Alpha-1-Antitrypsin-Deficiency-and-Provides-Pipeline-Update.html [15] NextCure Announces First Patient Dosed in the Phase 1 Study of LNCB74 (B7-H4 ADC) as Therapeutic for Treating Multiple Cancers. Retrieved January 17, 2025, from https://ir.nextcure.com/news-releases/news-release-details/nextcure-announces-first-patient-dosed-phase-1-study-lncb74-b7 [16] LAVA Doses First Patient in Phase 1 LAVA-1266 Study in Hematological Cancers. Retrieved January 17, 2025, from https://www.globenewswire.com/news-release/2025/01/10/3007674/0/en/LAVA-Doses-First-Patient-in-Phase-1-LAVA-1266-Study-in-Hematological-Cancers.html [17] Context Therapeutics Announces First Patient Dosed in the Phase 1 Clinical Trial of CTIM-76. Retrieved January 17, 2025, from https://www.globenewswire.com/de/news-release/2025/01/14/3009673/0/en/Context-Therapeutics-Announces-First-Patient-Dosed-in-the-Phase-1-Clinical-Trial-of-CTIM-76.html [18] Ocugen, Inc. Announces First Patient Dosed in Phase 1 Clinical Trial of OCU200—a Novel Integrin-Targeting Biologic for Diabetic Macular Edema. Retrieved January 17, 2025, from https://ir.ocugen.com/news-releases/news-release-details/ocugen-inc-announces-first-patient-dosed-phase-1-clinical-trial [19] ProMIS Neurosciences Initiates Phase 1b Clinical Trial (PRECISE-AD) in Alzheimer’s Disease. Retrieved January 17, 2025, from https://www.promisneurosciences.com/news-media/press-releases/detail/236/promis-neurosciences-initiates-phase-1b-clinical-trial [20] Aptose Announces First AML Patients Dosed with Tuspetinib Triplet Frontline Therapy in TUSCANY Trial. Retrieved January 17, 2025, from https://www.aptose.com/news-media/press-releases/detail/307/aptose-announces-first-aml-patients-dosed-with-tuspetinib [21] ORYZON announces first patient dosed in NCI-sponsored iadademstat in combination with venetoclax and azacitidine clinical trial in first line acute myeloid leukemia. Retrieved January 17, 2025, from https://www.oryzon.com/en/news-events/news/oryzon-announces-first-patient-dosed-nci-sponsored-iadademstat-combination [22] 한미약품-GC녹십자, ‘파브리병’ 국내 1/2상 IND 승인. Retrieved January 17, 2025, from https://www.biospectator.com/news/view/24043 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床1期多肽偶联药物

2025-01-16

·ioncology

2025 CASH丨邱少伟教授：2024年急性白血病进展综述

点击蓝字关注我们编者按急性白血病是一类严重威胁人类健康的血液系统恶性肿瘤，其治疗一直是医学领域的研究热点。2024年美国血液学会（ASH）年会上，急性白血病的诊疗研究取得了诸多重要进展，为临床实践带来了新的思路与希望。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）邱少伟教授在第五届中国血液学科发展大会（2025 CASH）上对急性髓系白血病（AML）和急性淋巴细胞白血病（ALL）的研究进展分别进行了详细阐述。《血液时讯》特整理成文，以飨读者。 01 AML研究进展（一）新型联合化疗方案崭露头角传统的“3+7”方案长期以来作为AML一线诱导治疗的标准，但仍有改进空间。在本次ASH会议中，众多新型联合方案成为研究焦点。山东大学齐鲁医院开展的研究（ASH P1521）探索了维奈克拉（VEN）联合伊达比星和阿糖胞苷用于初治AML患者的疗效。该研究纳入32例 18-60岁、ECOG 0-2分且先前未接受治疗的原发性AML患者。治疗方案为伊达比星（d1-3，12 mg/m²）、阿糖胞苷（d1-7，100 mg/m²）和口服维奈克拉（d4 100 mg、d5 200 mg、d6-11 400 mg）诱导治疗。结果显示，IAV方案在新诊断AML患者中具有显著的有效性和安全性，为AML一线治疗提供了新的有力选择。另一项针对老年适合强化疗的AML患者（Fit AML）的研究采用了VEN+克拉屈滨+低剂量阿糖胞苷（LDAC）交替VEN+阿扎胞苷（AZA）的治疗策略（ASH Oral56）。研究纳入141例初治老年AML患者，关键纳入标准包括年龄≥50岁或＜50岁不适合标准诱导化疗、ECOG 0-2分且肝肾功能充分。结果显示，复合完全缓解（CRc）率达到86%，44%的患者接受了CR1移植。该方案为老年AML患者的治疗提供了新的有效途径，并凸显了分子遗传学特征在治疗决策和预后判断中的重要性。一项关于艾伏尼布（IVO）+VEN±AZA治疗IDH1突变血液恶性肿瘤的Ib/II期研究2024年更新了研究数据（ASH Oral219）。这项研究的主要纳入标准是年龄大于等于18岁，患有IDH1 R132突变的复发/难治性（R/R）AML，新诊断的高风险骨髓增生异常综合征和/或骨髓增殖性肿瘤，ECOG PS评分≤2，以及具备足够的心脏、肝脏和肾脏功能。主要排除标准则是先前暴露于VEN或IVO的患者。在这项研究中，主要终点为安全性，以及5周期内的客观缓解率（ORR）。结果显示，MDS/MPN、新诊断的AML（ND-AML）及R/R AML的CRc率分别为100%、94%和83%，整体人群的中位OS尚未达到，中位无事件生存期（EFS）为50.4个月，中位缓解持续时间（mDOR）为43.4个月。不同类型IDH1突变髓系肿瘤，接受IVO+VEN±AZA方案的疗效有所差异。（二）靶向药物治疗成果显著近年来，随着对AML发病机制的深入理解，靶向药物的研发与联合应用成为研究热点。 FLT3-ITD和FLT3-TKD突变在AML中较为常见，影响患者预后。研究表明，三联疗法去甲基化药物（HMA）+VEN+FLT3i在新诊断不适合强化疗FLT3突变AML患者中可获得持久缓解和令人鼓舞的OS（ASH Oral220）。其中，可评估应答者中，81%获得流式MRD阴性（灵敏度 10-4）。FLT3-ITD突变患者中位OS为28.1个月，2年OS率为57%；FLT3-TKD突变患者中位OS为39.3个月，2年OS率为76%。年龄、NPM1突变状态、ELN风险分层或是否接受造血干细胞移植（SCT）对 OS均无显著影响，但RAS通路突变与较差的OS相关。这提示在AML治疗中，针对FLT3突变的靶向治疗联合其他药物具有重要临床意义，同时RAS通路可能成为未来研究的重要靶点以改善不良预后患者的生存状况。 2024 ASH上，Menin抑制剂在复发/难治性（R/R）AML治疗中取得重要进展。多种Menin抑制剂如Revumenib、Bleximenib、Enzomenib、Ziftomenib、BN104等在不同阶段的临床试验中展现出一定疗效。在AUGMENT-101 II期研究中（ASH Oral221），Revumenib针对所有R/R KMT2A急性白血病患者，ORR达63.9%，CR+CRh率为22.7%，且在不同KMT2A易位类型患者中均有一定响应。在另一项研究中（ASH Oral216），Revumenib(SNDX-5613）与地西他滨/Cedazuridine（ASTX727）和维奈克拉的全口服组合（SAVE）用于R/R AML，ORR高达82%，CR/CRh率为48%，且在 KMT2A、NPM1突变及NUP98重排等不同亚组患者中均有一定的缓解率，同时MRD阴性率在可评估患者中也达到65%。 Ziftomenib联合强化诱导（7+3）治疗新诊断的NPM1-m或KMT2A-r AML患者的KOMET-007研究1a期中期结果显示，该方案在所有剂量水平上耐受性良好，临床活性强大，NPM1突变和KMT2A重排患者的CRc率分别高达100%和83%，MRD阴性率在不同剂量组也表现较好，均≥75%，且较高剂量的Ziftomenib未影响中性粒细胞和血小板的恢复时间（ASH Oral214）。这些结果表明Menin抑制剂在R/R AML及特定基因突变AML治疗中具有巨大潜力，有望为改善患者预后带来新希望。（三）移植策略研究新突破在AML治疗中，造血干细胞移植是重要策略之一。ASAP研究对R/R AML患者移植前是否需要挽救性化疗进行了探讨（ASH Oral776）。该研究将281例患者按1:1随机分为两组：诱导缓解组（RIST）接受3 g/m²阿糖胞苷（＞60岁患者为 1g/m²），d1-3每天两次，d3-5接受10 mg/m²米托蒽醌（HAM），序贯allo-HSCT；疾病控制组（DISC）在预处理和allo-HSCT之前进行疾病控制，推荐等待观察（w&w），但允许低剂量阿糖胞苷（LDAC）和单剂量米托蒽醌用于疾病控制。主要终点为移植后56天CR率。结果显示，两组的治疗成功率、无病生存期（DFS）和OS均无统计学差异，但诱导缓解组住院天数更多，不良事件数也更多。这一研究结果对R/R AML患者的移植策略选择具有重要指导意义，提示缓解深度并不改善R/R AML移植患者OS，AML疾病特征是唯一影响因素。 02 ALL研究进展（一）Ph +ALL诱导治疗新方案费城染色体阳性（Ph+）ALL是ALL中的特殊亚型，预后较差。本次 ASH会议上报道了两种新的诱导治疗方案。一项单中心、II期研究评估了达沙替尼+奥加伊妥珠单抗在新诊断 Ph+ALL患者中的疗效与安全性（ASH P1432）。研究纳入19例年龄≥18岁、新诊断的Ph+ALL患者，治疗方案包括达沙替尼（140 mg/d 或根据情况调整）和奥加伊妥珠单抗联合化疗，并设定了详细的疗程和剂量方案。结果显示，所有患者中疗程2结束时完全分子学反应（CMR）率为63%，疗程3结束时CMR率高达89.4%；第二个周期结束后MRD阴性率为68%，疗程3结束后提升至89.5%，其中方案1的7位患者在第2疗程结束后100%实现MRD阴性。中位随访1.1年期间未观察到患者复发。安全性方面，常见3-4级不良事件（发生率≥10%）包括COVID-19、呼吸困难、贫血和疲乏等。此外，在IKZF1异常及IKZF1 plus人群中该方案获益显著，IKZF1异常患者疗程3结束时CMR率达100%。这表明达沙替尼+奥加伊妥珠单抗方案在Ph+ALL诱导治疗中疗效显著，尤其对特定基因异常患者效果更佳，且安全性总体可控。另一项单臂、II期研究评估了贝林妥欧单抗+达沙替尼一线治疗新诊断 Ph+ALL患者的疗效与安全性。研究纳入63例患者，采用贝林妥欧单抗（28 μg/d）和达沙替尼（140 mg/d）联合治疗。主要研究终点为诱导治疗2个周期后分子学反应（CMR+PNQ），次要研究终点包括MRD水平降低、DFS和OS等。结果显示，该方案在IKZF1突变Ph+ALL患者中分子学反应率较低，IKZF1 plus患者中仅有1例达到分子学反应（9%，1/11），低于IKZF1缺失组和无IKZF1缺失组（27%，9/33）；中位随访18个月时，IKZF1 plus患者的总体生存率低于无IKZF1缺失患者和IKZF1缺失患者，分别为2%、100%和93%。该研究提示贝林妥欧单抗+达沙替尼联合方案在IKZF1异常患者中的疗效有待进一步优化，为后续研究提供了参考方向。（二）Ph阴性B-ALL治疗进展老年费城染色体阴性B细胞急性淋巴细胞白血病（Ph-B-ALL）患者由于年龄和疾病特点，治疗面临诸多挑战。美国MD安德森癌症中心的一项开放标签、单中心I期研究对Mini-hyper-CVD+奥加伊妥珠单抗（InO）±贝林妥欧单抗在≥60岁Ph-B-ALL患者中的疗效与安全性进行了长达10年的随访（ASH P1441）。更新数据显示，入组时未达到CR的77例患者中有76例（99%）达到最佳缓解CR/CRi；81例可评估患者中有93%患者达到MRD阴性。经过121个月的中位随访，mPFS为46.6个月，mOS为61.6个月，5年PFS率、OS率及持续缓解期（CRD）率分别为48.1%、50.1%和79.4%。分次加入InO的方案，中位PFS为61.6个月，3年PFS率高达65%，较未调整之前有显著提升。在数据截止日期时，33例患者（39.8%）存活。该研究表明，Mini-hyper-CVD+奥加伊妥珠单抗±贝林妥欧单抗方案对老年Ph-B-ALL患者有效且耐受性良好，能带来长期生存获益，为老年患者的治疗提供了重要参考方案。此外，还有研究探索了更低剂量化疗联合奥加伊妥珠单抗+贝林妥欧单抗在老年Ph-ALL患者中的应用（ASH P1442），结果显示CR/CRi率为92%，MRD阴性率为100%，1年PFS率为55.4%，1年OS率为73.8%，且安全性良好，3级不良事件发生率较低。这些研究为老年Ph-ALL患者的治疗提供了更多选择，有助于根据患者的具体情况制定个性化治疗方案。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）则开展了一项单臂、Ⅱ期研究（ASH P4199），旨在评估奥加伊妥珠单抗用于首次CR缓解但MRD阳性Ph-B-ALL患者的有效性，并评估MRD水平从基线到奥加伊妥珠单抗给药后的变化。关键入组标准包括年龄≥18岁，首次缓解（CR1）的Ph-B-ALL患者，未达MRD阴性或MRD阳性复发，ECOG评分为0-2分，主要器官功能正常，且无活动性或其他恶性肿瘤且预期生存期≤12个月。所有患者疗程1均接受InO（0.5 mg/m² D1，D8，D15）治疗。若经流式细胞术检测到MRD阳性，则继续接受疗程2的治疗。研究终点为第一个周期内MRD阴性率。根据研究设计完成奥加伊妥珠单抗治疗的患者，其MRD阴性率为100%。此外，8位患者在完成奥加伊妥珠单抗治疗后进行了异基因造血干细胞移植，没有肝静脉闭塞病（VOD）。截至2024年7月，共有15例患者处于缓解期，2例出现复发。因此，在B-ALL患者达到缓解的早期阶段使用奥加伊妥珠单抗作为巩固治疗，即使接受1个疗程的治疗，也可实现较高的MRD阴性率，且安全性良好，并未增加移植后发生VOD的风险。（三）R/R B-ALL治疗新成果在复发/难治性B细胞急性淋巴细胞白血病（R/R B-ALL）治疗方面，一项美国多中心II期研究评估了Mini-Hyper-CVD联合奥加伊妥珠单抗±贝林妥欧单抗的疗效（ASH P2811）。研究纳入133例CD22阳性、R/R B-ALL患者，根据奥加伊妥珠单抗的不同给药方式分为三种不同队列。结果显示，总体人群的ORR为86%，CR率60%，其中D-D队列ORR高达 100%；第1周期后和总体治疗后的MRD阴性率分别为53%、85%，D-D队列分别为74%和95%。中位随访40个月，总人群中位OS为21个月，3年OS率为45%；中位无复发生存期（RFS）为19个月，3年RFS率为44%。安全性方面，共在10例患者中观察到SOS。该研究表明，Mini-Hyper-CVD联合奥加伊妥珠单抗±贝林妥欧单抗方案可为R/R B-ALL 患者带来更高深度缓解及MRD转阴率，且显著改善患者的生存预后，同时通过调整药物剂量和给药方式可降低VOD等严重不良反应的发生风险。 03 总结与展望 2024年ASH会议在急性白血病治疗领域呈现出诸多重要进展。在AML方面，新型联合化疗方案如IAV方案和针对老年患者的VEN+克拉屈滨+LDAC交替VEN+AZA方案显著提高了缓解率和患者生存预后；靶向药物联合治疗尤其是Menin抑制剂的研究成果为R/R AML及特定基因突变AML患者带来新希望；造血干细胞移植策略的研究也为临床决策提供了更精准的依据。在ALL领域，针对Ph+ALL的达沙替尼+奥加伊妥珠单抗等方案在诱导治疗中取得良好疗效，老年Ph-B-ALL和R/R B-ALL的治疗也有新的突破，为不同类型和年龄段的患者提供了更多有效的治疗选择。然而，目前仍存在一些挑战。例如，部分靶向药物可能存在耐药性问题，联合治疗方案的最佳组合和剂量仍需进一步优化，不同治疗方案在不同种族和个体差异较大的患者中的普适性也有待进一步研究。未来，随着对白血病发病机制的深入探索、新型药物的研发以及临床研究的不断开展，有望进一步提高急性白血病的治愈率。邱少伟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）白血病诊疗中心病区主任华中科技大学同济医学院本科北京协和医学院医学博士美国阿拉巴马大学伯明翰分校访问学者北京协和医学院硕士生导师天津市青年科技优秀人才以第一作者或通讯作者在Blood(2023), Leukemia(2022,2024), Cancer research(2024), J Clin Invest(2019), Cancer Communications(2023), Blood Cancer journal(2024)等杂志发表SCI论文研究领域为急性白血病发病耐药机制及免疫靶向治疗担任中国抗癌协会血液肿瘤专业委员会青年委员会委员，中国抗癌协会血液肿瘤专业委员会委员，天津市抗癌协会血液肿瘤专业委员会委员等主持国家自然基金、天津市自然基金、临床科研基金等；参与科技部重点研发计划、医科院创新工程等基金。（来源：《肿瘤瞭望–血液时讯》编辑部）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。

临床结果临床2期

2025-01-15

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Aptevo\'s Peter Pavlik, PhD, Chairing Session on \"Bi and Multispecific Biologics\" at Cambridge Healthcare Institute\'s Pep Talk 2025

Also giving an in-session talk titled \"Modular Multispecific Biotherapeutics: Rapid Therapeutic Design with the ADAPTIR® Platform,\" showcasing Aptevo\'s drug engineering and rational drug design expertise SEATTLE, WA / ACCESSWIRE / January 15, 2025 / Aptevo Therapeutics (\"Aptevo\") (NASDAQ:APVO) today announced that Peter Pavlik, PhD, Senior Director of Protein Engineering, will chair a session titled \"Bi and Multispecific Biologics\" and present a talk,\"Modular Multispecific Biotherapeutics: Rapid Therapeutic Design with the ADAPTIR® Platform,\" at the Cambridge Healthcare Institute\'s Pep Talk conference today.DetailsSession Title: Bi and Multispecific BiologicsTalk Title: Modular Multispecific Biotherapeutics: Rapid Therapeutic Design with the ADAPTIR™ Platform (talk being given as part of this session)Session Chair and Talk Presenter: Peter Pavlik, PhDDate/Time: Wednesday, January 15th from 3:15-5:20 US Pacific time.About Dr. PavlikPeter Pavlik, PhD, serves as the Senior Director of Protein Engineering at Aptevo Therapeutics. In his career at Aptevo and previously MedImmune/AstraZeneca and Los Alamos National Labs, he has implemented novel technologies to streamline discovery of binding domains and their incorporation into stable and efficacious biotherapeutics. Dr. Pavlik has oversight over all processes currently used at Aptevo, which are optimized to multiple areas of drug development from target validation to antibody discovery to IND and to clinic. Dr. Pavlik has a unique understanding of the biopharma industry from the large and small company perspectives.About Aptevo TherapeuticsAptevo Therapeutics Inc. (NASDAQ:APVO) is a clinical-stage biotechnology company focused on developing novel bispecific immunotherapies for the treatment of cancer. The company has two clinical candidates. Mipletamig is currently being evaluated in RAINIER, a Phase 1b/2 trial for the treatment of frontline acute myeloid leukemia in combination with standard of care venetoclax + azacitidine. Mipletamig has orphan status for AML according to the Orphan Drug Act. ALG.APV-527, a bispecific conditional 4-1BB agonist, only active upon simultaneous binding to 4-1BB and 5T4, is being co-developed with Alligator Bioscience and is being evaluated in a Phase 1 clinical trial for the treatment of multiple solid tumor types likely to express 5T4. The Company has three pre-clinical candidates with different mechanisms of action designed to target a range of solid tumors. All pipeline candidates were created from two proprietary platforms, ADAPTIR® and ADAPTIR-FLEX®. The Aptevo mission is to improve treatment outcomes and transform the lives of cancer patients. For more information, please visit www.aptevotherapeutics.com.Safe Harbor StatementThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical fact, including, without limitation, Aptevo\'s expectations regarding the effectiveness of its ADAPTIR® and ADAPTIR-FLEX® platform technologies and whether such technologies will accelerate drug discovery and development, statements related to the performance of Aptevo\'s drug candidates in the clinic and whether such performance will translate into improved patient outcomes, statements related to the progress of and enthusiasm for Aptevo\'s preclinical and clinical programs, statements related to Aptevo\'s ability to generate stockholder value, whether Aptevo will continue to have momentum in its business in the future, and any other statements containing the words \"may,\" \"believes,\" \"expects,\" \"potential,\" \"designed,\" \"engineered,\" \"innovative,\" \"initiate,\" \"allow,\" \"promise,\" \"plans,\" \"will\" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on Aptevo\'s current intentions, beliefs, and expectations regarding future events. Aptevo cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from Aptevo\'s expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement.There are several important factors that could cause Aptevo\'s actual results to differ materially from those indicated by such forward-looking statements, including a deterioration in Aptevo\'s business or prospects; further assessment of preliminary or interim data or different results from later clinical trials; adverse events and unanticipated problems, adverse developments in clinical development, including unexpected safety issues observed during a clinical trial; adverse developments in the U.S. or global capital markets, credit markets or economies generally; and changes in regulatory, social, macroeconomic, and political conditions. For instance, actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the uncertainties inherent in the initiation, enrollment and maintenance of patients in clinical trials, uncertainties inherent in the results of preliminary or interim data and preclinical and clinical studies being predictive of the results of later-stage clinical trials, the availability and timing of data from ongoing clinical trials, the trial design includes combination therapies that may make it difficult to accurately ascertain the benefits of mipletamig, expectations for the timing and steps required in the regulatory review process, expectations for regulatory approvals, the impact of competitive products, our ability to enter into agreements with strategic partners or raise funds on acceptable terms or at all and other matters that could affect the availability or commercial potential of the Company\'s product candidates, business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises such as the novel coronavirus (referred to as COVID-19), geopolitical risks, including the current war between Russia and Ukraine as well as the war between Israel and Hamas, and macroeconomic conditions such as rising inflation and interests rates, increased market volatility and decreased consumer confidence. These risks are not exhaustive, Aptevo faces known and unknown risks. Additional risks and factors that may affect results are set forth in Aptevo\'s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and its subsequent reports on Form 10-Q and current reports on Form 8-K. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Aptevo\'s expectations in any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, Aptevo does not assume any obligation to update any forward-looking statement to reflect new information, events, or circumstances.Aptevo TherapeuticsMiriam Weber MillerEmail: [email protected] or [email protected]Phone: 206-859-6629SOURCE: Aptevo TherapeuticsRelated Documents:

免疫疗法临床1期孤儿药

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
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	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	波多黎各	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
复发性急性髓细胞白血病	临床3期	美国	AbbVie, Inc.	2022-10-01
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	日本	Genentech, Inc.	2022-10-01

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临床结果

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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


NCT04477486 (CTgov)	临床2期	套细胞淋巴瘤	13	Ibrutinib+Venetoclax	淵選遞齋範窪獵窪艱膚(醖願簾繭繭鹹鏇醖積顧) = 選夢齋簾糧醖鑰觸繭壓構夢衊築糧觸選願鬱製 (鹹範淵築鏇繭膚獵網醖, 範憲構獵觸願夢窪繭齋 ~ 艱網醖鹹醖顧顧窪醖膚)	-	2025-01-14
ASH2024 人工标引	临床1期	非霍奇金淋巴瘤	13	Loncastuximab tesirine + Venetoclax	鏇襯積顧觸襯願窪構窪(艱鏇構壓觸積蓋餘簾襯) = 觸獵鏇鹹醖鹽壓淵醖網夢網淵蓋鹹構艱積衊衊 (遞顧積積鹽願窪蓋艱膚 ) 更多	积极	2024-12-09
ASH2024 人工标引	N/A	慢性淋巴细胞白血病一线	-	Venetoclax + obinutuzumab (VO)	選餘廠衊範鑰築鬱選願(鑰願醖繭廠齋憲繭繭夢) = 窪願遞齋網顧膚廠壓網範網獵選鑰鏇齋鑰壓繭 (餘憲顧觸襯選窪糧壓醖 ) 更多	积极	2024-12-09
				Bruton tyrosine kinase inhibitor (BTKi)	選餘廠衊範鑰築鬱選願(鑰願醖繭廠齋憲繭繭夢) = 顧觸製艱齋獵網餘憲襯範網獵選鑰鏇齋鑰壓繭 (餘憲顧觸襯選窪糧壓醖 ) 更多
NCT03836261 (AMPLIFY, ASH2024) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib + Venetoclax	鹹獵繭遞糧鏇鹹鏇範製(衊膚遞衊膚蓋積衊糧選) = 膚獵獵憲鏇餘觸鹹膚齋壓鏇鹽積襯繭簾構糧衊 (築壓積願齋鑰艱繭鏇蓋 ) 更多	积极	2024-12-09
				Acalabrutinib + Venetoclax + Obinutuzumab	鹹獵繭遞糧鏇鹹鏇範製(衊膚遞衊膚蓋積衊糧選) = 糧蓋襯壓夢糧膚製獵鹽壓鏇鹽積襯繭簾構糧衊 (築壓積願齋鑰艱繭鏇蓋 ) 更多
NCT03709758 (ASH2024) 人工标引	临床1期	急性髓性白血病一线	44	Venetoclax + Daunorubicin + Cytarabine	齋廠顧鏇鏇鬱鬱蓋齋製(網鹽觸襯鹽鹽網窪顧壓) = 100 mg/d venetoclax was the MTD for pts treated with consol ara-C at 3 gm/m2. 鬱鬱醖壓襯築夢衊獵選 (築廠觸獵膚醖壓遞簾窪 ) 更多	积极	2024-12-09
NCT05996406 (ASH2024) 人工标引	临床2期	免疫球蛋白轻链淀粉样变性一线 t(11;14)	29	Venetoclax + Dexamethasone	鹽鏇觸鬱糧簾簾淵憲鬱(蓋壓簾獵醖顧襯淵夢遞) = 網鹹繭鏇範襯遞艱觸簾願範鬱夢鑰顧憲蓋夢淵 (壓衊顧觸鹽築鬱廠襯範 ) 更多	积极	2024-12-09
ASH2024 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	選夢選窪願製構範鑰憲(衊築選壓鹹鑰壓餘淵糧) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) 窪鏇獵簾製獵鹹艱繭觸 (壓齋衊鹹醖窪鏇廠襯鬱 ) 更多	积极	2024-12-09
				Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide
ASH2024	N/A	急性髓性白血病	-	Navitoclax/Venetoclax/Decitabine Combination	鹽範繭鬱衊夢簾膚淵製(築遞願鹹鹹鬱鬱鹽網積) = 構淵選窪構憲鏇鬱築膚遞膚網構選鬱艱蓋鏇製 (獵鑰顧艱觸醖簾獵構繭 )	-	2024-12-09
ASH2024	N/A	急性髓性白血病	-	FLAG-IDA+VEN or CLIA+VEN	顧壓遞糧選選顧願壓遞(簾齋夢獵遞網獵襯餘壓) = 鏇築製鏇窪鏇顧醖網廠襯壓衊夢醖窪觸構襯襯 (積淵築積製獵鹽襯積衊, 13 ~ 27) 更多	-	2024-12-09
				cladribine, low-dose cytarabine +VEN	顧壓遞糧選選顧願壓遞(簾齋夢獵遞網獵襯餘壓) = 鹽餘廠簾鑰選構鹽齋顧襯壓衊夢醖窪觸構襯襯 (積淵築積製獵鹽襯積衊, 16 ~ 35) 更多
ASH2024	N/A	-	-	Venetoclax-Azacitidine	願觸鑰憲襯糧構醖夢遞(範鏇鏇鬱蓋簾鹽構餘艱) = 遞淵顧簾鹹選遞鬱繭構積遞獵醖鑰繭衊淵願壓 (夢艱鬱齋選憲範顧製鏇 ) 更多	-	2024-12-09
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