Phase II Study of Cytarabine + Daunorubicin (7 + 3) + Gemtuzumab Ozogamicin vs. Cytarabine + Daunorubicin (7 + 3) + Venetoclax for the Treatment of Newly Diagnosed Core Binding Factor Acute Myeloid Leukemia (CBF-AML) in Younger Adults: A MyeloMATCH Substudy

This phase II MyeloMATCH treatment trial compares the effect of venetoclax to gemtuzumab ozogamicin, when given with cytarabine and daunorubicin ("7+3" regimen), for the treatment of patients with core binding factor acute myeloid leukemia (CBF-AML). 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. Gemtuzumab ozogamicin is a monoclonal antibody, called gemtuzumab, linked to an antitumor antibiotic drug, called ozogamicin. Gemtuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD33 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as cytarabine and daunorubicin 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. Giving venetoclax with cytarabine and daunorubicin may have fewer side effects and be as effective or better than the combination with gemtuzumab ozogamicin in treating patients with core binding factor AML.

开始日期2025-11-20

申办/合作机构

National Cancer Institute

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]

NCT06520098

/ Not yet recruiting临床2期IIT

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax.
The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

开始日期2025-07-01

申办/合作机构

VA Office of Research and Development

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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4,948

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.

2025-12-31·CANCER BIOLOGY & THERAPY

Targeting the IKZF1/BCL-2 axis as a novel therapeutic strategy for treating acute T-cell lymphoblastic leukemia

Article

作者: Li, Jun ; Ye, Chunmei ; Li, Hui ; Li, Juan

OBJECTIVES:

Acute T-cell lymphoblastic leukemia (T-ALL) is a severe hematologic malignancy with limited treatment options and poor long-term survival. This study explores the role of IKZF1 in regulating BCL-2 expression in T-ALL.

METHODS:

CUT&Tag and CUT&Run assays were employed to assess IKZF1 binding to the BCL-2 promoter. IKZF1 overexpression and knockdown experiments were performed in T-ALL cell lines. The effects of CX-4945 and venetoclax, alone and in combination, were evaluated in vitro and in vivo T-ALL models.

RESULTS:

CUT&Tag sequencing identified IKZF1 binding to the BCL-2 promoter, establishing it as a transcriptional repressor. Functional assays demonstrated that IKZF1 overexpression reduced BCL-2 mRNA levels and increased repressive histone marks at the BCL-2 promoter, while IKZF1 knockdown led to elevated BCL-2 expression. CX-4945, a CK2 inhibitor, could reduced BCL-2 levels in T-ALL cells. Notably, knockdown of IKZF1 partially rescued the CX-4945-induced repression of BCL-2. These results underscore the CK2-IKZF1 signaling axis as a key regulator of BCL-2 expression. In vitro, CX-4945 enhanced the cytotoxicity of venetoclax, with the combination showing significant synergistic effects and increased apoptosis in T-ALL cell lines. In vivo studies with cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models demonstrated that CX-4945 and venetoclax combined therapy provided superior therapeutic efficacy, reducing tumor burden and prolonging survival compared to single-agent treatments.

CONCLUSIONS:

IKZF1 represses BCL-2 in T-ALL, and targeting the CK2-IKZF1 axis with CX-4945 and venetoclax offers a promising therapeutic strategy, showing enhanced efficacy and potential as a novel treatment approach for T-ALL.

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.

1,364

项与维奈克拉相关的新闻（医药）

2025-04-08

·PRNewswire

TIBSOVO's Continued Success Solidifies Its Position as a Leader in IDH1 Mutant Space | DelveInsight

With its ability to specifically inhibit the mutant IDH1 enzyme, TIBSOVO addresses an unmet need in personalized cancer treatment, offering new hope for patients with limited options. As clinical evidence continues to support its efficacy and safety, TIBSOVO is positioned for strong growth in the oncology market, especially with expanding indications and global market penetration. LAS VEGAS, April 8, 2025 /PRNewswire/ -- DelveInsight's " TIBSOVO Market Size, Forecast, and Market Insight Report" highlights the details around TIBSOVO, the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of TIBSOVO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Servier's TIBSOVO (ivosidenib) Overview TIBSOVO (ivosidenib) is a small molecule developed by Servier, acts as an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is indicated for patients with a susceptible IDH1 mutation, which is identified through an FDA-approved test. Currently, TIBSOVO is approved for the treatment of newly diagnosed acute myeloid leukemia (AML), relapsed or refractory AML, relapsed or refractory myelodysplastic syndromes (MDS), and locally advanced or metastatic cholangiocarcinoma. According to Servier's pipeline, TIBSOVO is also being actively investigated for a range of additional indications, with key areas of exploration including solid tumors and hematological malignancies. Learn more about TIBSOVO projected market size for AML, cholangiocarcinoma, and MDS @ TIBSOVO Market Potential The oncology market has experienced significant growth in recent years, driven by advances in cancer research, the development of targeted therapies, and the increasing global prevalence of cancer. As the second-leading cause of death worldwide, cancer continues to pose a major public health challenge, creating a substantial demand for innovative treatments. The market is marked by a shift toward personalized medicine, where therapies are tailored to an individual's genetic profile, allowing for more effective and less toxic treatments. Immunotherapies, such as checkpoint inhibitors, CAR-T cell therapies, and oncolytic virus therapies, are at the forefront of these advancements, offering new hope to patients with previously untreatable cancers. Moreover, the oncology market is expanding due to the growing adoption of precision oncology and molecular diagnostics, which enable earlier and more accurate detection of cancer. This has led to increased investments in research and development, especially in areas like liquid biopsies, companion diagnostics, and next-generation sequencing. The demand for more effective and accessible cancer treatments is fueling innovation in both the pharmaceutical and biotechnology sectors, with numerous new drugs and therapies entering clinical trials and moving toward commercialization. As a result, the oncology market is poised to continue growing, with significant opportunities for breakthrough therapies in immuno-oncology, targeted treatments, and gene therapies. DelveInsight has expertise in the oncology market with an experienced team handling the oncology domain proficiently. DelveInsight has released a series of epidemiology-based market reports on Acute Myeloid Leukemia, Cholangiocarcinoma, and Myelodysplastic Syndrome. These reports include a comprehensive understanding of current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Gain deeper insights into these diseases with a customized report tailored to your needs. Connect with us today—our experts are ready to assist you! Emerging Competitors of TIBSOVO TIBSOVO faces significant competition in the newly diagnosed AML market from several alternative treatments. Oral therapies like VENCLEXTA (venetoclax), which inhibits BCL-2, and DAURISMO (glasdegib), which targets the hedgehog pathway, present strong contenders. Additionally, emerging therapies such as Lisaftoclax (Ascentage Pharma), another BCL-2 inhibitor, and gilteritinib (Astellas), a kinase inhibitor, are expected to further challenge TIBSOVO in the newly diagnosed AML space. In the R/R AML market, TIBSOVO competes with several therapies, including XOSPATA (gilteritinib), IDHIFA (enasidenib), and others. Emerging therapies such as Ziftomenib (Kura Oncology) and RVU-120 (Ryvu Therapeutics) are also expected to compete with TIBSOVO upon their approval. Ziftomenib, a small molecule developed by Kura Oncology, is currently in Phase I/II trials. In the relapsed/refractory (R/R) MDS market, TIBSOVO faces competition from therapies such as RYTELO (Imetelstat), an IV injection that inhibits oligonucleotide telomerase, and REBLOZYL (Luspatercept), a subcutaneous injection, among other treatment options. In the metastatic cholangiocarcinoma market, TIBSOVO faces relatively less competition, as there are few approved therapies. One such competitor is PEMAZYRE (pemigatinib), a kinase inhibitor that was approved in the US in 2020 and in Europe in 2021. Whereas, Tyra Biosciences' TYRA-200, an FGFR1/2/3 inhibitor, is in phase I stage of development that might be a threat to TIBSOVO one approved. To know more about the number of competing drugs in development, visit @ TIBSOVO Market Positioning Compared to Other Drugs Key Developmental Activities of TIBSOVO In October 2023, Servier announced that the FDA has approved TIBSOVO (ivosidenib tablets) for the treatment of IDH1-mutated R/R MDS. In May 2023, Servier announced that the European Commission has approved TIBSOVO as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed AML with an isocitrate dehydrogenase-1 R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy. In May 2022, Servier announced FDA approval of TIBSOVO (ivosidenib tablets) in combination with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia. In August 2021, Servier announced FDA approval for TIBSOVO (ivosidenib tablets) for the treatment of adult patients with previously treated, locally advanced, or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved test. TIBSOVO is the first and only targeted therapy approved for patients with previously treated IDH1-mutated cholangiocarcinoma. In May 2019, Agios announced FDA approval of TIBSOVO (ivosidenib tablets) as monotherapy for newly diagnosed adult patients with IDH1 mutant acute myeloid leukemia not eligible for intensive chemotherapy. In July 2018, the FDA approved TIBSOVO (ivosidenib) for relapsed or refractory acute myeloid leukemia with an idh1 mutation. In February 2018, the FDA accepted a new drug application and granted priority review for ivosidenib in relapsed or refractory AML with an IDH1 mutation. In December 2017, Agios submitted an NDA to the FDA for ivosidenib for the treatment of patients with relapsed/refractory aml and an IDH1 mutation. TIBSOVO Patent Details TIBSOVO is a drug owned by Servier Pharmaceuticals. Currently, it is protected by 10 Orange book-listed patents filed from 2018 to 2023, out of which none have expired yet. It is also protected by ODE exclusivity for various indications. Discover how TIBSOVO is shaping the blood cancer treatment landscape @ TIBSOVO Side Effects TIBSOVO Market Dynamics In recent years, the therapeutic landscape has undergone significant changes, with promising approaches including immunotherapy, chemotherapy combined with targeted treatments, and the regulation of immune checkpoint-mediated signaling pathways. One such treatment, Ivosidenib, works by inducing the bone marrow to develop normal blood cells, helping to reduce the frequency of blood transfusions. Investment in the research and development of drugs has surged, contributing to a rich pipeline and forecasting promising opportunities in the treatment markets for AML and cholangiocarcinomas. Therapies like TIBSOVO have the potential to capture market attention due to their efficacy and innovation. As healthcare spending continues to rise globally, the pharmaceutical market is expected to expand, providing greater opportunities for market penetration by manufacturers and facilitating the development and distribution of new treatments. Despite progress in cancer treatment, significant gaps remain in understanding the full process that governs carcinogenesis and resistance to treatments, particularly in cancers like acute myeloid leukemia (AML). This highlights the need for more advanced research to address these challenges. Additionally, the limited biomarker testing for patients with the IDH1 mutation restricts the targeted patient pool, posing a challenge for therapies like TIBSOVO to achieve their expected market share. The increasing competition from emerging therapies, such as KEYTRUDA (pembrolizumab), IMFINZI (durvalumab), and the combination of Azacitidine + Venetoclax, further intensifies the pressure on TIBSOVO. Moreover, the difficulty in obtaining sufficient patient pools and diagnostic samples during disease recurrence presents significant hurdles to the effective development of translational research, potentially slowing progress in optimizing treatments. Dive deeper to get more insight into TIBSOVO's strengths & weaknesses relative to competitors @ TIBSOVO Market Drug Report Table of Contents Related Reports Acute Myeloid Leukemia Market Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Relapsed/Refractory Acute Myeloid Leukemia Market Relapsed/Refractory Acute Myeloid Leukemia Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R AML companies including Agios Pharmaceuticals, Abbvie, Jazz Pharmaceuticals, Astellas Pharma, Pfizer, Novartis Oncology, Daiichi Sankyo, AstraZeneca, Astex Pharmaceuticals, Inc., Chimerix, Takeda, Rafael Pharmaceuticals Inc., Delta-Fly Pharma, GlycoMimetics Incorporated, BerGenBio ASA, MacroGenics, Syndax Pharmaceuticals, Arog Pharmaceuticals, Forma Therapeutics, Sellas Life Sciences Group, Actinium Pharmaceuticals, Clear Creek Bio Inc., CellCentric Ltd., Biosight Ltd., Astex Pharmaceuticals, Inc., Curis, Inc., NexImmune Inc., Immunomedics, Inc., Sumitomo Dainippon Pharma Co., Ltd., Incyte Corporation, Aprea Therapeutics, Immunicum, DCPrime BV, GT Biopharma, Inc., Hanmi Pharmaceutical Company Limited, Cardiff Oncology, Bio-Path Holdings, Actinium Pharmaceuticals, Aptevo Therapeutics, Synimmune GmbH, GEMoaB Monoclonals, ImmunoGen, Inc., AGC Biologics S.p.A., Precigen, Inc., Novartis Pharmaceuticals, Xencor, Inc., Novartis, Celgene, Bristol Myers Squibb, among others. Myelodysplastic Syndrome Market Myelodysplastic Syndrome Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key MDS companies such as Bristol-Myers Squibb, Astex Pharmaceutical, Taiho Oncology, Fibrogen, AbbVie, Gilead Sciences, Novartis, Syros Pharmaceuticals, Takeda, Pfizer, Geron Corporation, Karyopharm Therapeutics, Antengene Corporation, BerGenBio ASA, Jazz Pharmaceuticals, Aprea Therapeutics, Sanofi, Medac, among others. Cholangiocarcinoma Market Cholangiocarcinoma Market Insight, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key cholangiocarcinoma companies such as AstraZeneca, Decalth Systems, Basilea Pharmaceutica, Taiho Oncology, Eisai Pharmaceuticals, TransThera Sciences, Incyte Corporation, Roche, Agios Pharmaceuticals, Servier Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准免疫疗法临床1期优先审批

2025-04-08

·GlobeNewswire-Health Care

SELLAS Announces Positive Overall Survival in Cohort 3 from the Ongoing Phase 2 Trial of SLS009 in r/r AML

- 8.9 Months Median Overall Survival (mOS) in Patients with AML-Myelodysplasia-Related Changes (AML-MRC) and 8.8 mOS in All Relapsed or Refractory to Venetoclax-Based Regimens Patients; Surpassing Historical Benchmark of 2.5 Months - - Overall Response Rate (ORR) of 67% Achieved in Patients with AML-MRC (Target Patient Population of SLS009 in r/r AML) – Exceeding Targeted 20% ORR - - Trial Continues with Full Data and FDA Regulatory Path Feedback Expected in 1H 2025 – NEW YORK, April 08, 2025 (GLOBE NEWSWIRE) -- 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 Cohort 3 data from the ongoing Phase 2 trial of SLS009 (tambiciclib), a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). “The remarkable results from Cohort 3 of the ongoing Phase 2 trial reinforce the potential of SLS009 to transform outcomes for these heavily pretreated AML patients,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “Not only have we observed unprecedented survival benefits, but the high response rate underscores the therapy’s efficacy profile. The data reveal that relapsed or refractory to venetoclax-based regimens patients receiving 30 mg BIW achieved a mOS of 8.8 months, far surpassing the historical benchmark of 2.5 months. Additionally, the therapy demonstrated a 67% ORR in patients with AML-MRC and 46% in all evaluable patients, significantly exceeding the targeted 20% ORR. With responses seen across different genetic mutations, this approach could be transformational for many underserved patients. We are continuing to explore SLS009's potential in expansion cohorts to further validate its potential to address critical unmet medical needs.” Patients Characteristics: 14 relapsed and refractory AML patients who previously failed venetoclax-based therapies were enrolled and treated with SLS009 and venetoclax/azacitidine in Cohort 3. 10 out of 14 patients (71%) had AML MRC (acute myeloid leukemia with myelodysplasia-related cytogenetics). 4 of those patients had myelomonocytic phenotype (M4 per FAB classification). The myelomonocytic phenotype has been shown to exhibit inferior responses to venetoclax-based therapies. It is thought to depend more on the MCL1 anti-apoptotic protein than on the BCL2 anti-apoptotic protein.In terms of specific mutations, 6 patients had ASXL1, 5 had RUNX1 and 3 had TP53. The median age was 71 (range 35-89 years).The median number of prior failed therapy was 1 (range 1-6).13/14 patients were evaluable for efficacy.All patients had adverse risk cytogenetics per ELN 2022. Key Results from Cohort 3: The median overall survival (mOS) for all patients in Cohort 3 was 8.8 months, while the mOS in AML MRC patients reached 8.9 months.The overall response rate (ORR) in all evaluable patients was 46% in all Cohort 3 patients and 67% in AML-MRC patients, far exceeding the targeted ORR of 20%. In the subgroup of patients with myelomonocytic AML, 75% of patients responded (3 out of 4). Among patients with mutation ASXL1, 4/6 (67%) responded; among those with RUNX1 3/5 (60%) responded, and among those with TP53 1/3 (33%) responded. In addition, there were 3 patients with adverse karyotypes and 1 responded.SLS009 was well-tolerated with no new safety signals observed to date as the regimen remains safe in additional patients enrolled to date.Phase 2 trial continues in expansion cohorts 4 and 5, in patients with AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation (cohort 4) and mutations and cytogenic changes other than ASXL1 (cohort 5). The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were treated at either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include two additional cohorts, one with ASXL1 mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1. The target response rate at the optimal dose level is 20% with a target median survival of at least 3 months. In addition, the study aims to identify biomarkers for the target patient population and enrichment for further trials. For more information on the study, visit clinicaltrial.gov identifier NCT04588922. About SELLAS Life Sciences Group, Inc. 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. For more information on SELLAS, please visit www.sellaslifesciences.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 20, 2025 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com

临床2期临床结果

2025-04-05

·ioncology

EBMT大咖访谈丨卢岳教授：“移”路春晖，CR与MRD照亮KMT2A重排急性白血病预后之路

EBMT 2025四月风来满座春，千秋智汇启新辰。第51届欧洲血液与骨髓移植学会年会（EBMT 2025）于2025年3月30日至4月2日在意大利佛罗伦萨召开，作为血液学领域极具影响力的国际盛会，吸引了全球五千余名专家学者参与，共同探讨造血干细胞移植与细胞治疗的前沿进展。本次会议上，河北燕达陆道培医院卢岳教授团队入选了一项口头报告（摘要号：OS6-04）和一项壁报（摘要号：B272），研究成果备受瞩目。OS6-04研究聚焦于KMT2A重排急性白血病患者的异基因造血干细胞移植，揭示了移植前CR状态及移植后早期分子MRD监测对预后的影响，为临床精准决策提供了关键证据；B272研究则证实了移植前分子水平检测与多参数流式细胞术检测是独立不良预后因素，为临床监测策略优化提供了重要依据。《肿瘤瞭望-血液时讯》特邀卢岳教授分享并解读这些研究成果及其临床意义，邀您一同见证中国学者在KMT2A重排急性白血病治疗领域的“移”路春晖，共同开启生命新程。《肿瘤瞭望-血液时讯》此次EBMT会议，您团队的研究成果备受瞩目，共有1项口头报告和1项壁报入选。首先，能否请您为我们详细介绍一下OS6-04这项口头报告的内容？卢岳教授该研究作为我院单中心的报道，共纳入455例接受异基因造血干细胞移植的KMT2A基因重排急性白血病（KMT2A-r-AL）患者，是目前该领域样本量较大的临床研究。移植前缓解状态情况：CR1期273例（60.0%），CR2期98例（21.5%），未缓解（NR）84例（18.4%）。5年OS和LFS均为65%。进一步分析显示，不同缓解状态患者的预后存在显著差异：CR1患者的5年OS和LFS可达78%，CR2患者为60%，而NR患者仅为34%。值得注意的是，CR1 MRD阴性患者的5年OS和LFS可进一步提升至83%。这一结果明确提示，快速达到缓解尤其是达到分子生物学深度缓解、且在CR1期接受allo-HSCT的患者获益最为显著。在接受单倍体移植、以白消安（BU）为基础的清髓预处理方案的移植体系下，分析了移植前不同缓解状态对预后的影响。结果显示，与达到缓解的患者相比，未缓解（NR）患者预后更差，表现为更高的复发率和移植相关死亡率；在达到CR的患者中，≥CR2 MRD（分子检测和MFC检测）双阳性患者的预后较CR1患者更差；而在CR1患者中，移植前分子MRD阳性患者预后更差。此外，移植后100天内早期分子MRD阳性的患者也表现出更高的复发率和更低的生存率。该研究还展示了这一特殊生物学类型急性白血病的不同伴侣基因和基因突变的全景及其预后影响。在AML中，合并RAS信号通路突变以及不同融合伴侣基因（如MLLT3、AFDN等）之间未观察到显著的生存差异；但在ALL中，AF6融合及合并TP53突变的患者表现出更高的复发率和更低的生存率，同时AL初诊时高白细胞血症（外周血白细胞计数≥100×10⁹/L）也提示不良预后。需要注意的是，虽然年龄在KMT2A-r-AL预后中的影响有限，但是本研究仅显示在CR1亚群中≤1岁的患者中的预后影响，部分结果与既往报道并不一致，这也显示出了KMT2A-r这类患者巨大的预后异质性。摘要号：OS6-04 英文标题：Pre-transplant CR status and Molecular MRD Within 100 Days Post-transplant were Predict Survival and Relapse Risk factor in KMT2A-Rearranged Acute Leukemia中文标题：移植前完全缓解状态及移植后100天内分子微小残留病可预测KMT2A重排急性白血病生存和复发风险（上下滑动查看更多）背景异基因造血干细胞移植（allo-HSCT）是目前唯一能治愈KMT2A重排急性白血病的方法，但移植前后影响长期生存的预后因素尚未明确。方法本研究纳入2012年4月至2023年12月期间确诊为KMT2A重排急性白血病并接受allo-HSCT的患者。移植后通过实时荧光定量PCR（RTFQ-PCR）定期监测白血病特异性基因异常（KMT2A融合伴侣基因）。结果共纳入455例患者（男238例，儿童217例）。最常见的融合基因类型为KMT2A-MLLT3（119例），其次为KMT2A-AFDN（90例）、KMT2A-AFF1（80例）、KMT2A-MLLT10（74例）、KMT2A-ELL（35例）、KMT2A-MLLT1（32例），KMT2A-MLLT11和KMT2A-MLLT1各6例，KMT2A-EPS15和KMT2A-SEPTN6各3例，其他KMT2A重排4例。确诊时，128例（28.1%）外周血白细胞计数>100×10⁹/L，77例（29.4%）伴复杂核型，52例（19.6%）为FLT3-ITD突变，11例（4.1%）为FLT3-TKD突变，42例（15.9%）携带不利基因突变，61例（13.4%）存在髓外浸润。根据造血干细胞移植合并症指数（HCT-CI）评分，322例（70.7%）为0分，122例（26.8%）为1分，11例（2.4%）≥2分。多数患者（367/455，80.6%）接受单倍体移植。移植前缓解状态：CR1期273例（60.0%），CR2期98例（21.5%），未缓解（NR）84例（18.4%）。345例（75.8%）采用白消安（BU）为基础的预处理方案，其中242例（53.1%）接受强化预处理。幸存者中位随访时间为48个月（范围：10-148个月）。所有队列患者5年总生存率（OS）和无白血病生存率（LFS）均为65.7%（95% CI：63.3%-68.1%），5年累积复发率（CIR）和非复发死亡率（NRM）分别为12.6%（95%CI：10.8%-14.4%）和24.6%（95% CI：22.4%-26.8%）。多因素分析显示：移植前达到CR状态的患者OS更高[HR （95% CI），1.568（1.385-1.775），P=0.001]，LFS更高[HR（95% CI），1.568（1.385-1.775），P=0.001]、CIR更低[HR（95% CI），1.424（1.136-1.748），P=0.002]、NRM更高[HR（95% CI），1.658（1.432-1.918），P=0.001]；移植后100天内分子学MRD阳性患者OS更低[HR（95% CI），0.375（0.253-0.556），P=0.001]、LFS更低[HR（95% CI），0.375（0.253-0.556），P=0.001]、CIR更高[HR（95% CI），0.136（0.073-0.253），P=0.001]；HCT-CI≥2分患者NRM更高[HR（95% CI），1.488（1.054-2.100），P=0.024]。其他因素（如年龄、KMT2A融合基因亚型、复杂核型、基因突变、髓外浸润、供体类型等）与预后无显著相关性。结论本项研究的长期随访结果表明，移植前CR状态和移植后100天内分子学MRD是预测KMT2A重排急性白血病生存和复发风险的关键因素。《肿瘤瞭望-血液时讯》OS6-04研究揭示了移植前后影响长期生存的预后因素。为改善患者预后，您对临床医生在移植决策和术后管理方面有何具体建议？卢岳教授异基因造血干细胞移植是目前治愈KMT2A-r AL的一种重要且有效的治疗方法。然而，影响其预后的因素，目前国内外众多研究虽有诸多报道，但不同研究中心得出的结论存在差异。这些因素包括诊断时的年龄、融合伴侣基因类型、合并的基因突变类型、初诊时白细胞计数是否偏高、是否合并复杂染色体异常、是否合并髓外病变、移植前的疾病状态以及MRD状态等。目前比较统一的观点是移植前能否达到缓解以及缓解的深度是影响预后的独立因素。要实现理想的治疗结局，需要在治疗过程中对每个步骤进行精细把控，因此如何在初诊断时实现个体化治疗并快速达到深度缓解便成为关键。当前传统化疗药物已接近疗效极限，而靶向药物展现出新的希望：其中Menin抑制剂最具前景但尚未可及；其他潜在有效靶点包括FLT3抑制剂、蛋白酶体抑制剂、去甲基化药物、组蛋白去乙酰化酶抑制剂、BCL-2抑制剂、RAS通路抑制剂、BET抑制剂以及免疫治疗等。除达到深度缓解外，移植全程的精准决策同样关键。第一，移植时机的选择至关重要。多项研究数据表明在CR1期进行allo-HSCT能使患者最大程度获益。第二，预处理方案。近期由南方医科大学南方医院牵头的一项多中心研究[1]显示，含地西他滨（Dec）的强化预处理方案与标准清髓性预处理方案相比，可显著降低KMT2A-r AL患者的3年累积复发率（17.6% vs. 34.5%），并改善LFS（70.1% vs. 56.0%）。第三，供者选择。EBMT急性白血病工作组（ALWP）于2024年开展的一项研究证实，与MSD和MUD相比，HID具有更强的GVL效应，在不增加NRM的前提下可降低复发风险（HID 39% vs. MSD 70.6% vs. MUD 56.1%），最终提高2年LFS（HID 58.7% vs. MSD 52.8% vs. MUD 43.4%）。最后，基于MRD状态的抢先治疗，如使用维奈克拉、去甲基化药物维持治疗等，也可改善患者的预后。各个环节环环相扣、紧密衔接，才能最终提高患者的无病生存率。未来研究应着重于：深入理解KMT2A-r AL的生物学特性；探索传统治疗与新型靶向药物的个体化联合策略；优化MRD监测指导下的精准干预；以及完善移植全程各环节的把控。唯有如此，才能从根本上改善这类难治性患者的预后。《肿瘤瞭望-血液时讯》在B272研究中，对于KMT2A重排AML患者和KMT2A-PTD AML患者，移植前MRD监测方法对于改善患者预后有何意义？卢岳教授KMT2A-r是AML中常见的分子遗传学异常，包括易位、部分串联重复（PTD）、缺失、插入、倒置等几种形式，其中以KMT2A基因易位最为常见，而KMT2A-PTD（MLL-PTD）重排阳性患者仅占新发AML的3%～5%。伴KMT2A-r AML患者通常预后较差，与融合的伴侣基因的致病机制可能不太一样。该研究将AML中各类KMT2A融合伴侣基因与PTD合并分析，旨在探讨在CR1期接受allo-HSCT时，评估MRD的最佳监测策略——即MFC与分子水平检测方法两者谁更具临床指导价值。目前，KMT2A易位伴侣基因及KMT2A-PTD尚未被指南纳入MRD分子标志，但多项研究提示其具有潜在价值。然而，在临床实践中，MFC和分子水平检测结果不一致的情况时有发生。本研究的多因素分析结果显示，MFC和分子水平双阳性是预后不良的独立因素。在双阳性患者中，5年CIR明显高于其他患者（23.7% vs. 7.4%），而NRM相似。因此，双阳性患者的5年OS和LFS均显著降低（均为54.4% vs. 77.9%），且与其他单一MFC或分子水平阳性等因素无关。此研究提示，在临床实践中，尤其是对于具有标志性分子的患者，MRD和分子水平的评估方法需要多维度综合考虑，以更准确地指导治疗决策和预后评估。摘要号：B272 英文标题：Pre-Transplant MRD Double Positive Detection by Molecular and MFC Were the Independent Dismal Prognostic Factor in KMT2A-Translocation Partner Genes and KMT2A-PTD AML in CR1中文标题：移植前通过分子检测和多参数流式细胞术（MFC）检测到的微小残留病（MRD）双阳性是KMT2A易位伴侣基因和KMT2A-PTD急性髓系白血病（AML）患者在首次完全缓解（CR1）中的独立不良预后因素1（上下滑动查看更多）背景移植前微小残留病（MRD）状态是预测KMT2A易位伴侣基因及KMT2A-PTD（部分串联重复）急性髓系白血病（AML）患者在首次完全缓解（CR1）期接受移植后预后的重要指标。然而，目前尚未明确分子检测（如实时荧光定量PCR，RTFQ-PCR）与多参数流式细胞术（MFC）哪种方法更具预后预测的优势，以及是否需要联合使用。方法本研究纳入2012年4月至2023年12月期间确诊为KMT2A易位伴侣基因或KMT2A-PTD AML且在CR1期接受异基因造血干细胞移植（allo-HSCT）的患者。移植前骨髓（BM）样本的MRD监测采用两种方法：分子检测（RTFQ-PCR靶向白血病特异性基因异常）与多参数流式细胞术（MFC）（检测白血病相关抗原异常）。结果共纳入264例患者（男性124例，儿童147例）。最常见的融合基因类型为KMT2A-MLLT3（64例），其次为KMT2A-MLLT10（47例）、KMTA-AFDN（39例）、KMT2A-ELN（21例），KMT2A-MLLT11和KMT2A-MLLT1各6例，KMT2A-EPS15和KMT2A-SEPTN6各3例，其他KMT2A重排4例，另有KMT2A-PTD 71例。确诊时，55例（20.8%）外周血白细胞计数>100×10⁹/L，77例（29.4%）伴复杂核型，52例（19.6%）为FLT3-ITD突变，11例（4.1%）为FLT3-TKD突变，42例（15.9%）携带不利基因突变，25例（9.4%）存在髓外浸润。多数患者（200/264，75.7%）接受单倍体移植。移植前MRD状态：分子学阳性106例（40.6%），MFC阳性61例（20.2%），分子学与MFC双阳性50例（18.9%）。257例（70.2%）采用白消安（BU）为基础的预处理方案，其中160例为强化方案。幸存者中位随访时间为42个月（范围：10-142个月）。所有队列5年生存数据：5年总生存率（OS）与5年无白血病生存率（LFS）均为75.4%（95%CI：72.5%-78.3%）；5年累积复发率（CIR）为9.2%（95%CI：7.1%-11.3%）；5年非复发死亡率（NRM）为16.5%（95%CI：13.9%-19.1%）。MRD双阳性组（分子学+MFC）预后显著更差：5年OS和5年LFS更低，均为54.4%（95%CI：43.7%-63.3%）vs. 77.9%（95%CI：75.0%-80.18%），P=0.008；5年CIR更高：23.7%（95%CI：17.0%-31.4%） vs. 7.4%（95%CI：5.3%-9.5%），P=0.000；NRM两组相似，29.9%（95%CI：19.1%-38.9%）vs. 14.6%（95%CI：12.1%-17.1%），P=0.614。多因素分析显示：移植前MRD双阳性是唯一独立预后不良因素，OS更低[HR（95% CI）,0.479（0.274-0.835），P=0.010]、LFS更低[HR（95% CI）,0.479（0.274-0.835），P=0.010]、CIR更高[HR（95% CI）,0.210（0.087-0.505），P=0.001]；单方法检测（分子学或MFC）的MRD阳性与预后无显著关联；其他因素（如年龄、KMT2A融合亚型、复杂核型、基因突变、髓外浸润、供体类型等）均无相关性。结论移植前通过分子检测（RTFQ-PCR）和MFC检测到的MRD双阳性，是唯一能明确提示不良预后和更高复发风险的独立因素，提示需优化预处理方案，并在移植后采取针对性干预措施，以降低复发风险并改善总体生存。参考文献1.Hu, Z., Feng, Z., Liu, S. et al. Intensified conditioning containing decitabine versus standard myeloablative conditioning for adult patients with KMT2A-rearranged leukemia: a multicenter retrospective study. BMC Med 22, 605 (2024). https://doi.org/10.1186/s12916-024-03830-0会场花絮卢岳教授河北燕达陆道培医院河北燕达陆道培医院移植科主任医师（副院长级）北京血液学分会理事中华医学会血液学分会造血干细胞移植应用组成员海峡两岸医药卫生交流协会血液病学专业委员会委员2016年10月赴美国西雅图Fred Hutchinson骨髓移植中心进修临床截止至2023年底，已经累计完成异基因造血干细胞移植例数1500余例在Frontiers in immunology、British journal of haematology、Bone marrow transplantation、Bilology of Blood Marrow Transplantation等杂志上发表SCI 10余篇（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。

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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
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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
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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

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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	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
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	AbbVie, Inc.	2022-10-01

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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


NCT02942290 (Pubmed \| Blood)	临床1期	高危骨髓增生异常综合征	107	Venetoclax 400 mg	鑰積鬱糧築餘鹹齋糧襯(鑰蓋網觸積選襯夢衊窪) = 鏇鹹築淵艱窪繭鹽簾餘醖觸鹹膚醖製蓋憲壓築 (獵積簾蓋顧選選艱遞衊 ) 更多	积极	2025-03-13
NCT03236857 (Pubmed \| Pediatr Blood Cancer)	临床1期	复发性儿童急性淋巴细胞白血病	-	Venetoclax monotherapy	鑰範獵艱蓋膚簾願淵鏇(鏇醖積鏇壓夢蓋淵襯壓) = One fatal adverse event possibly related to venetoclax occurred 鏇襯膚獵鏇構膚遞獵積 (壓鏇鏇窪襯簾鬱鏇醖壓 ) 更多	积极	2025-03-10
NCT03214562 (Pubmed \| Leukemia)	临床1/2期	难治性急性髓细胞白血病 wild-type TP53 status	138	FLAG-IDA + Venetoclax	淵鹹構願餘構襯窪觸膚(艱廠構窪糧觸築顧鹽選) = low 獵築餘艱繭簾積壓構構 (遞醖淵壓淵築製範網獵 ) 更多	积极	2025-02-25
NCT03836261 (NEWS \| Pubmed) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib-Venetoclax	廠夢糧鹹築廠鹽衊選願(築鬱觸築簾製夢壓蓋積) = 鏇餘鬱網鏇鬱顧鹽構憲構鹽範鬱選鏇製願憲餘 (廠憲鏇積衊餘襯鑰壓壓 ) 更多	积极	2025-02-21
NCT03836261 (NEWS \| Pubmed) 人工标引	临床3期	慢性淋巴细胞白血病一线	867	Acalabrutinib-Venetoclax-Obinutuzumab	廠夢糧鹹築廠鹽衊選願(築鬱觸築簾製夢壓蓋積) = 鏇廠壓襯衊鏇構遞壓淵構鹽範鬱選鏇製願憲餘 (廠憲鏇積衊餘襯鑰壓壓 ) 更多	积极	2025-02-21
NCT03319901 (Pubmed \| Blood Adv)	临床1期	急性淋巴细胞白血病 hypodiploid TP53-mutated	19	Venetoclax + Mini-HCVD	範糧遞鑰襯選蓋衊獵壓(鹽積鏇窪憲簾遞淵餘壓) = 製網鬱獵糧壓淵觸獵夢製廠鹽鬱簾襯顧蓋淵艱 (鑰簾網蓋築觸夢願繭窪, 71 ~ 100) 更多	积极	2025-02-11
NCT04599634 (CTgov)	临床1期	滤泡性淋巴瘤 \| 套细胞淋巴瘤 \| 慢性淋巴细胞白血病 ... 更多	11	venetoclax+magrolimab+obinutuzumab (Arm 1, Cohort 1 Follicular Lymphoma Level 1)	蓋鏇鏇襯艱遞鹹顧簾願 = 觸夢觸膚遞壓鏇鏇艱艱觸夢憲淵顧顧構醖積製 (網膚網觸齋遞範齋蓋餘, 廠艱蓋膚淵鏇襯範蓋網 ~ 網獵夢襯願醖製繭壓糧) 更多	-	2025-02-04
NCT04599634 (CTgov)	临床1期	滤泡性淋巴瘤 \| 套细胞淋巴瘤 \| 慢性淋巴细胞白血病 ... 更多	11	venetoclax+magrolimab+obinutuzumab (Arm 2, Cohort 2 Marginal Zone Lymphoma, Mantle Cell Lymphoma, & Chronic Lymphocytic Leukemia Level 1)	蓋鏇鏇襯艱遞鹹顧簾願 = 願簾製齋構選鏇衊鹽選觸夢憲淵顧顧構醖積製 (網膚網觸齋遞範齋蓋餘, 衊製鹽衊艱窪遞餘憲鹹 ~ 遞襯觸網襯蓋鑰廠範壓) 更多	-	2025-02-04
NCT04477486 (CTgov)	临床2期	难治性套细胞淋巴瘤	13	Ibrutinib+Venetoclax	憲獵衊鬱築廠鹹構觸觸 = 鬱鏇觸蓋鬱廠構鏇齋襯壓遞鏇鏇衊範簾顧廠鬱 (衊齋觸淵顧憲膚願襯窪, 製願壓觸網遞壓鏇憲鏇 ~ 選夢醖築製廠膚鏇齋窪)	-	2025-01-14
NCT03223610 (ASH2024) 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 2IbrutinibPrednisoneObinutuzumabLenalidomide	憲簾構範窪蓋築鹽選鏇(衊糧憲鏇範鹽齋淵糧鬱) = thrombocytopenia (14%), neutropenia (13%), and anemia (10%) 鹹構憲築淵膚鹹選鹹鹽 (選願鹹夢衊窪選糧醖願 ) 更多	积极	2024-12-09
NCT03223610 (ASH2024) 人工标引	临床1/2期	套细胞淋巴瘤	36	Venetoclax 4IbrutinibPrednisoneObinutuzumabLenalidomide		积极	2024-12-09
ASH2024 人工标引	临床1期	非霍奇金淋巴瘤	13	Loncastuximab tesirine + Venetoclax	窪鑰襯窪夢顧積築範夢(夢衊顧憲簾遞襯觸簾餘) = 鹹衊構壓醖選醖鏇鹹淵顧顧淵糧獵鏇築範夢夢 (顧憲鑰繭繭願網膚鏇觸 ) 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	網廠膚壓憲艱艱廠繭簾(醖網繭艱醖顧廠簾齋遞) = 鹽願獵鹽憲壓構選繭壓夢鹹窪遞鹹廠壓壓遞壓 (蓋衊膚壓衊醖網鹹鬱網 ) 更多	积极	2024-12-09