A Randomized Phase 2 Study of Bendamustine, Rituximab, Cytarabine (AraC) Induction With Zanubrutinib (BRAZAN) Followed by Zanubrutinib/Rituximab +/- Sonrotoclax Maintenance in Treatment-Naïve Mantle Cell Lymphoma

This study aims to evaluate the efficacy and safety of an induction regimen combining Bendamustine, Rituximab, Cytarabine (AraC), and Zanubrutinib (BRAZAN), followed by maintenance therapy with Zanubrutinib and Rituximab with or without Sonrotoclax in participants with Mantle Cell Lymphoma (MCL).
The names of the study drugs involved in this study are:
* bendamustine (a type of alkylating agent)
* rituximab (a type of monoclonal antibody)
* cytarabine (a type of antineoplastic)
* zanubrutinib (a type of kinase inhibitor)
* sonrotoclax (a type of BCL2 inhibitor)

开始日期2025-08-01

申办/合作机构

Dana-Farber Cancer Institute, Inc.

[+1]

NCT06557330

/ Not yet recruiting临床2期IIT

HM-225: Measurable Residual Disease (MRD) Guided De-intensification of Bendamustine/Rituximab (BR) for Indolent Non-Hodgkin Lymphoma

This is a phase II pilot, single arm, open label study designed to assess the efficacy, safety, and feasibility of MRD adapted duration of BR for untreated or R/R iNHL.

开始日期2025-06-01

申办/合作机构

The Fox Chase Cancer Center

[+1]

NCT06094842

/ Withdrawn临床1期IIT

A Phase I Safety and Feasibility Study of Cellular Immunotherapy for Extensive Stage Small Cell Neuroendocrine Prostate Cancer Using Autologous T Cells Lentivirally Transduced to Express L1CAM-Specific Chimeric Antigen Receptor

This phase I trial studies the side effects and best dose of autologous CD8+ and CD4+ lentivirally transduced to express L1CAM-specific chimeric antigen receptor (CAR) and EGFRt mutation specific T cells and to see how well they work in treating patients with small cell neuroendocrine prostate cancer (SCNPC) that has spread to nearby tissue or lymph nodes (locally advanced) and cannot be removed by surgery (unresectable) or has spread from where it first started (primary site) to other places in the body (metastatic). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells is added to the T cells in the laboratory. Some solid tumor cells have an L1CAM protein on their surface, and T cells can be modified with a receptor, called a chimeric antigen receptor (CAR), to help recognize this protein and kill these tumor cells. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. These L1CAM mutation specific T cells may help the body's immune system identify and kill L1CAM locally advanced and unresectable or metastatic small cell neuroendocrine prostate cancers' tumor cells.

开始日期2025-04-15

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

100 项与盐酸苯达莫司汀相关的临床结果

登录后查看更多信息

100 项与盐酸苯达莫司汀相关的转化医学

登录后查看更多信息

100 项与盐酸苯达莫司汀相关的专利（医药）

登录后查看更多信息

2,978

项与盐酸苯达莫司汀相关的文献（医药）

2025-04-01·CHEST

A New Pulmonary Nodule in a Patient With a History of Lymphoma

Article

作者: Pezzuto, Federica ; Calabrese, Fiorella ; Giraudo, Chiara ; Marino, Dario ; Scapinello, Greta ; Vilaia, Alexandra ; Piazza, Francesco

CASE PRESENTATION:

A 70-year-old woman who formerly used tobacco was referred for evaluation of a lung nodule incidentally discovered during hematologic follow-up. Her medical history was notable for a stage IV follicular lymphoma (G2/G3A stage IV, for pleural and perinephric involvement, FLIPI4) in September 2022, for which she received 6 courses of obinutuzumab plus bendamustine. After the second cycle of therapy, an increase in transaminases was detected; the subsequent diagnostic workup showed a positive real-time polymerase chain reaction blood test for human herpesvirus 6 DNA with more than 13,000 copies/mL. The human herpesvirus 6 infection was successfully treated with acyclovir, followed by normalization of liver enzymes. The treatment was then completed regularly, obtaining a complete metabolic response. One month after completing therapy, the patient developed systemic cytomegalovirus infection with associated pneumonia, requiring 3 weeks of hospitalization. Considering the severity of the infectious event, a further maintenance with obinutuzumab was excluded. Persistent cytomegalovirus-DNA levels necessitated valganciclovir. Sustained neutropenia partially improved with granulocyte colony-stimulating factor administration.

2025-04-01·Lancet Haematology

Talicabtagene autoleucel for relapsed or refractory B-cell malignancies: results from an open-label, multicentre, phase 1/2 study

Article

作者: Fry, Terry ; Neelapu, Sattva S ; Narula, Gaurav ; Chowdhury, Ambalika ; Kumar, Pavan ; Boyella, Pavan Kumar ; Vaibhaw, Anand ; Kulkarni, Atul ; Ravikumar, Smrithi ; Chatterjee, Gaurav ; Pramesh, CS ; Poojary, Minal ; Navukudkar, Anisha ; Stroncek, David ; Purwar, Rahul ; Sridhar, Epari ; Joshi, Sharvari ; Laskar, Siddhartha ; Basu, Moumita ; Patkar, Nikhil ; Gala, Kunal ; Ojha, Shashank ; Shet, Tanuja ; Karulkar, Atharva ; Melinkeri, Sameer ; Jain, Yash ; Dhamale, Shraddha ; Rangarajan, Venkatesh ; Sengar, Manju ; Bagal, Bhausaheb ; Gujral, Sumeet ; Rajendra, Akhil ; Tungare, Asmita ; Agrawal, Archi ; Highfill, Steven L ; Agarwal, Minu ; Sharma, Neha ; Jain, Nitin ; Rajyopadhye, Shreewardhan ; Agarwal, Narendra ; Gokaran, Anant ; Haldar, Rohan ; Sakhadeo, Uma ; Dwivedi, Alka ; Beher, Rohit ; Banavali, Shripad ; Shah, Shreshtha ; Firfiray, Afrin ; Kakoti, Sangeeta ; Jaiswal, Ankesh Kumar ; Mulik, Gayatri ; Mirjolkar, Amit ; Ghosh, Kinjalka ; Aribandi, Anil ; Firfire, Mahewish ; Eipe, Thomas ; Shah, Nirali N ; Khan, Aalia ; Asija, Sweety ; Shetty, Nitin ; Bhosale, Shilpushp ; Salunke, Gaurav ; Jain, Hasmukh ; Goda, Jayant ; C.S, Ranjit Kumar ; Nayak, Lingaraj ; Khattry, Navin ; Biswas, Sanjay ; Rajpal, Sweta ; Tembhare, Prashant ; Wilson, Lovin ; Purwar, Shalini ; Punatar, Sachin ; Kalra, Devanshi ; Subramanian, Papagudi ; Shetty, Alok ; Baheti, Abhijit ; Saroha, Ashish ; Gupta, Sudeep ; Mirgh, Sumeet ; Pendhari, Juber ; Bhurani, Dinesh ; Desai, Priti ; Banik, Ankit ; Hiregoudar, Sumathi ; Sundharam, Manivasagam ; Prabhakaran, Anusree

BACKGROUND:

In low-income and middle-income counties (LMICs), the outcome of relapsed or refractory B-cell malignancies is poor due to the absence of effective therapies. We report the results of a phase 1/2 study of a novel humanised anti-CD19 4-1BB chimeric antigen receptor (CAR) T-cell therapy, talicabtagene autoleucel, for patients with relapsed or refractory B-cell malignancies.

METHODS:

This open-label, multicentre, phase 1/2 study was done at six tertiary cancer centres in India. Phase 1 was a single-centre study done in Tata Memorial Hospital, India, in patients aged 18 years or older with relapsed or refractory B-cell lymphomas. Phase 2 was a single-arm, multicentre, basket trial done in five tertiary cancer centres in patients aged 15 years and older with relapsed or refractory B-cell acute lymphoblastic leukaemia or B-cell lymphoma. Eligible patients had a life expectancy of 12 weeks or more, an ECOG performance status of 0-1 (phase 1) or 0-2 (phase 2), and an adequate organ function. Patients underwent apheresis to obtain at least 1 × 10⁹ lymphocytes to manufacture CAR T cells. Lymphodepletion therapy was done with cyclophosphamide 500 mg/m² and fludarabine 30 mg/m² for 3 days or bendamustine 90 mg/m² for 2 days. Patients were then infused intravenously with talicabtagene autoleucel 1 × 10⁷-5 × 10⁹ CAR T cells in a fractionated schedule (10%, 30%, and 60%, on days 0, 1, and 2, respectively) during phase 1 or at least 5 × 10⁶ CAR T cells per kg (up to 2 × 10⁹ CAR T cells) on day 0 during phase 2. The primary endpoints were safety (phase 1) and overall response rate (phase 2). The efficacy analysis was done in the efficacy evaluable cohort (all patients who received the target dose and 3 days of lymphodepletion therapy). The safety analysis was done in the safety population (all patients who received talicabtagene autoleucel). The trials are registered with Clinical Trial Registry-India (CTRI/2021/04/032727 and CTRI/2022/12/048211), and enrolment is closed.

FINDINGS:

Of 64 patients, 14 were enrolled in phase 1 (from May 11, 2021, to May 13, 2022) and 50 were enrolled in phase 2 (Dec 27, 2022, to Aug 31, 2023). The median age of the overall cohort was 44 years (IQR 27-57), and 49 (77%) of 64 patients were male and 15 (23%) were female. In phase 1, no dose-limiting toxicities occurred at doses of 2 × 10⁶-17 × 10⁶ CAR T cells per kg. A dose of at least 5 × 10⁶ CAR T cells per kg was chosen for phase 2 based on a complete response in three of seven patients at this dose. The most common grade 3 or worse toxicities were haematological events: anaemia (35 [61%] of 57 patients), thrombocytopenia (37 [65%] patients), neutropenia (55 [96%] patients, and febrile neutropenia (27 [47%]) patients). There were two treatment-related deaths, one due to febrile neutropenia, immune-effector cell associated haemophagocytic lymphohistiocytosis, and septic shock, and the second due to pulmonary bleed, multiorgan dysfunction syndrome, and cytokine release syndrome. In 51 efficacy-evaluable patients (36 with B-cell lymphoma and 15 with B-cell acute lymphoblastic leukaemia), the overall response rate was 73% (37 of 51; 95% CI 59-83).

INTERPRETATION:

Talicabtagene autoleucel had a manageable safety profile and induced durable responses in patients with relapsed or refractory B-cell malignancies. This therapy addresses an important unmet need for patients with relapsed or refractory B-cell malignancies in India.

FUNDING:

Immunoadoptive Cell Therapy (ImmunoACT) and Indian Council of Medical Research (ICMR).

2025-03-20·BLOOD

MRD-guided zanubrutinib, venetoclax, and obinutuzumab in relapsed CLL: primary end point analysis from the CLL2-BZAG trial

Article

作者: Al-Sawaf, Othman ; Schneider, Christof ; Illert, Anna Lena ; Robrecht, Sandra ; Bittenbring, Jörg ; Giza, Adam ; Cramer, Paula ; Fink, Anna ; Graeven, Ullrich ; Stumpf, Janina ; Fürstenau, Moritz ; Weiss, Jonathan ; Kreuzer, Karl-Anton ; Eichhorst, Barbara ; Tausch, Eugen ; Langerbeins, Petra ; Kleinert, Fanni ; Ritgen, Matthias ; Simon, Florian ; Hallek, Michael ; Brüggemann, Monika ; Hebart, Holger ; Schilhabel, Anke ; Schöttker, Björn ; Heinrich, Bernhard ; Stoltefuß, Andrea ; Stilgenbauer, Stephan ; Fischer, Kirsten ; Eckert, Robert

Abstract:

The phase 2 CLL2-BZAG trial tested a measurable residual disease (MRD)–guided combination treatment of zanubrutinib, venetoclax, and obinutuzumab after an optional bendamustine debulking in patients with relapsed/refractory chronic lymphocytic leukemia (CLL). In total, 42 patients were enrolled and 2 patients with ≤2 induction cycles were excluded from the analysis population per protocol. Patients had a median of 1 prior therapy (range, 1-5); 18 patients (45%) had already received a Bruton tyrosine kinase (BTK) inhibitor (BTKi); 7 patients (17.5%) venetoclax; and, of these, 5 (12.5%) had received both. Fifteen patients (37.5%) had a TP53 mutation/deletion, and 31 (77.5%) had unmutated immunoglobulin heavy chain variable region gene. With a median observation time of 21.5 months (range, 8.0-35.3) the most common adverse events were COVID-19 (n = 26 patients), diarrhea (n = 15), infusion-related reactions (n = 15), thrombocytopenia (n = 14), nausea (n = 12), fatigue (n = 12), and neutropenia (n = 12). Two patients had fatal adverse events (COVID-19, and fungal pneumonia secondary to COVID-19). After 6 months of the triple combination, all patients responded, and 21 (52.5%; 95% confidence interval, 36.1-68.5) showed undetectable MRD (uMRD) in the peripheral blood. In many patients, remissions deepened over time, with a best uMRD rate of 85%. The estimated progression-free and overall survival rates at 18 months were 96% and 96.8%, respectively. No patient has yet required a subsequent treatment. In summary, the MRD-guided triple combination of zanubrutinib, venetoclax, and obinutuzumab induced deep remissions in a relapsed CLL population enriched for patients previously treated with a BTKi/venetoclax. This trial was registered at www.clinicaltrials.gov as #NCT04515238.

491

项与盐酸苯达莫司汀相关的新闻（医药）

2025-04-14

·GlobeNewswire-Health Care

Fate Therapeutics Receives Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA for FT819 to Treat Moderate to Severe Systemic Lupus Erythematosus (SLE)

– Recognizes potential of off-the-shelf CAR T-cell therapy to address significant unmet need and enables increased dialogue with FDA throughout the development process – RMAT review by FDA included initial clinical safety and activity data from ongoing Phase 1 study of FT819 in SLE – Additional Phase 1 clinical data of FT819 to be presented at medical conferences in 2025 SAN DIEGO, April 14, 2025 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived off-the-shelf cellular immunotherapies to patients, today announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to FT819, an investigational, off-the-shelf, iPSC-derived CAR T-cell therapy in Phase 1 clinical development for the treatment of active moderate to severe systemic lupus erythematosus (SLE), including lupus nephritis (LN). “RMAT designation recognizes the unique therapeutic potential of our off-the-shelf CAR T-cell therapy to address the unmet need of a wide range of lupus patients,” said Bob Valamehr, Ph.D., MBA, President and Chief Executive Officer of Fate Therapeutics. “We believe our current development strategy for FT819, which is designed to provide CAR T-cell therapy on-demand in a cost-effective manner and alleviate patient burden associated with intense conditioning chemotherapy and extended hospitalization, may enable treatment in the community setting and access to patients in underserved areas. With this designation, we look forward to working closely with the FDA as we seek to accelerate development of FT819 to bring this unique treatment to patients across the continuum of care.” The Company’s RMAT application included initial clinical safety and activity data from patients treated with FT819 in its ongoing multi-center Phase 1 clinical trial. The Phase 1 study is designed to evaluate the safety and efficacy of a fludarabine (flu)-free conditioning regimen, consisting of either bendamustine alone or cyclophosphamide alone, followed by a single dose of FT819. The Company is currently conducting dose expansion in up to 10 patients at 360 million cells, and is also assessing the safety, pharmacokinetics, and anti-B cell activity of FT819 at 900 million cells in dose escalation. The Company will report additional clinical data from the Phase 1 study of FT819 at scientific meetings later in 2025. The clinical development of FT819 is supported by a $7.9 million grant from the California Institute of Regenerative Medicine (CIRM). The RMAT designation was established under the 21st Century Cures Act to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. RMAT designation includes all Breakthrough Therapy designation features, such as early interactions with the FDA, including discussions on potential surrogate or intermediate endpoints that may support accelerated approval and satisfy post-approval requirements, and potential priority review of a product’s biologics license application. About Fate Therapeutics’ iPSC Product PlatformHuman induced pluripotent stem cells (iPSCs) possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Company’s proprietary iPSC product platform combines multiplexed-engineering of human iPSCs with single-cell selection to create clonal master iPSC lines. Analogous to master cell lines used to mass produce biopharmaceutical drug products such as monoclonal antibodies, the Company utilizes its clonal master iPSC lines as a starting cell source to manufacture engineered cell products which are well-defined and uniform in composition, can be stored in inventory for off-the-shelf availability, can be administered in combination with other therapies, and can potentially reach a broad patient population. As a result, the Company’s platform is uniquely designed to overcome numerous limitations associated with patient- and donor-sourced cell therapies. Fate Therapeutics’ iPSC product platform is supported by an intellectual property portfolio of over 500 issued patents and 500 pending patent applications. About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com. Forward-Looking StatementsThis release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the advancement of and plans related to the Company's product candidates, clinical studies and preclinical research and development programs, the Company’s progress, plans and timelines for the clinical investigation of its product candidates, the initiation and continuation of enrollment in the Company’s clinical trials, the initiation of additional clinical trials, including in new indications, and additional dose cohorts in ongoing clinical trials of the Company’s product candidates, the availability of data from the Company’s clinical trials and the Company’s plans to provide updates on its clinical trials, the therapeutic and market potential of the Company’s research and development programs and product candidates, and the Company’s clinical and product development strategy. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Company’s research and development programs and product candidates, including those product candidates in clinical investigation, may not demonstrate the requisite safety, efficacy, or other attributes to warrant further development or to achieve regulatory approval, the risk that results observed in prior studies of the Company’s product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Company’s product candidates or in the initiation and conduct of, or enrollment of patients in, any clinical trials, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, changes in the therapeutic, regulatory, or competitive landscape for which the Company’s product candidates are being developed, the amount and type of data to be generated or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Company’s ongoing and planned clinical trials, difficulties in manufacturing or supplying the Company’s product candidates for clinical testing, failure to demonstrate that a product candidate has the requisite safety, efficacy, or other attributes to warrant further development, and any adverse events or other negative results that may be observed during preclinical or clinical development), the risk that its product candidates may not produce therapeutic benefits or may cause other unanticipated adverse effects, and the risk that research funding and milestone payments received by the Company from CIRM may be less than expected. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time in the Company’s press releases and other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise. Contact: Christina TartagliaPrecision AQ212.362.1200christina.tartaglia@precisionaq.com

细胞疗法免疫疗法临床1期快速通道加速审批

2025-03-31

·astrazeneca.com

Calquence plus chemoimmunotherapy recommended for approval in the EU by CHMP as first and only BTK inhibitor for 1st-line mantle cell lymphoma

AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab has been recommended for approval in the European Union (EU) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous hematopoietic stem cell transplantation. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on the results from the ECHO Phase III trial which were presented at the European Hematology Association 2024 Congress. Results from the ECHO trial showed Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.73; 95% confidence interval [CI] 0.57-0.94; p=0.016). Median progression-free survival (PFS) was 66.4 months for patients treated with the Calquence combination versus 49.6 with chemoimmunotherapy alone. This recommendation for Calquence as a combination treatment in the 1st-line MCL setting follows the recent CHMP positive opinion for Calquence as a monotherapy for the treatment of adult patients with relapsed or refractory MCL. Martin Dreyling, MD, Department of Medicine, University Hospital LMU Munich, and investigator in the trial, said: "Results from the pivotal ECHO trial demonstrated the significant benefits of the Calquence combination in managing this rare and aggressive cancer. Today’s recommendation is an important advance within the mantle cell lymphoma first-line treatment landscape, especially for older patients who need a balance of efficacy and tolerability.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “Today's positive recommendation from the CHMP further reinforces the potential of Calquence to advance first-line treatment options in mantle cell lymphoma, with the Calquence combination demonstrating an almost one and a half year improvement in progression-free survival in this setting. If approved, Calquence has the potential to transform the standard of care as the first BTK inhibitor approved for these patients in Europe.” MCL is a rare and typically aggressive form of non-Hodgkin lymphoma, often diagnosed at an advanced stage.1,2 It is estimated that more than 6,000 patients were diagnosed with MCL in the UK, France, Germany, Spain and Italy in 2024.3 The safety and tolerability of Calquence was consistent with its known safety profile, and no new safety signals were identified. Calquence plus bendamustine and rituximab is approved in the US and several other countries in this setting based on the ECHO results. Regulatory applications are currently under review in Japan and several other countries in this indication. Notes Mantle cell lymphoma (MCL) While MCL patients initially respond to treatment, patients do tend to relapse.4 MCL comprises about 3-6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; It is estimated that there are more than 21,000 patients diagnosed with MCL in the US, UK, France, Germany, Spain, Italy, Japan and China.3,4,5 ECHO ECHO is a randomised, double-blind, placebo-controlled, multi-centre Phase III trial evaluating the efficacy and safety of Calquence plus bendamustine and rituximab compared to SoC chemoimmunotherapy (bendamustine and rituximab) in adult patients at or over 65 years of age (n=635) with previously untreated MCL.6 Patients were randomised 1:1 to receive either Calquence or placebo administered orally twice per day, continuously, until disease progression or unacceptable toxicity. Additionally, all patients received six 28-day cycles of bendamustine on days 1 and 2 and rituximab on day 1 of each cycle, followed by rituximab maintenance for two years if patients achieved a response after induction therapy.6 The primary endpoint is PFS assessed by an Independent Review Committee; other efficacy endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR) and time to response (TTR).6 The trial was conducted in 27 countries across North and South America, Europe, Asia and Oceania.6 The ECHO trial enrolled patients from May 2017 to March 2023, continuing through the COVID-19 pandemic. Prespecified PFS and OS analyses censoring for COVID-19 deaths were conducted to assess the impact of COVID-19 on the study outcome in alignment with the FDA. Patients with blood cancer remain at a disproportionately high risk of severe outcomes from COVID-19, including hospitalisation and death compared to the general population.6,7,8 Calquence Calquence (acalabrutinib) is a second-generation, selective inhibitor of Bruton’s tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis and adhesion. Calquence is approved for the treatment of chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL) in the US and Japan, approved for CLL in the EU and many other countries worldwide and approved in China for relapsed or refractory CLL and SLL. Calquence is also approved for the treatment of adult patients with previously untreated MCL in the US and other countries. It is also approved for the treatment of adult patients with MCL who have received at least one prior therapy in the US, China and several other countries. Calquence is not currently approved for the treatment of MCL in Japan. As part of an extensive clinical development programme, Calquence is currently being evaluated as a single treatment and in combination with standard-of-care chemoimmunotherapy for patients with multiple B-cell blood cancers, including CLL, MCL and diffuse large B-cell lymphoma. AstraZeneca in haematology AstraZeneca is pushing the boundaries of science to redefine care in haematology. Our goal is to help transform the lives of patients living with malignant, rare and other related haematologic diseases through innovative medicines and approaches that are shaped by insights from patients, caregivers and physicians. In addition to our marketed products, we are spearheading the development of novel therapies designed to target underlying drivers of disease across multiple scientific platforms. Our acquisitions of Alexion, with expertise in rare, non-malignant blood disorders, and Gracell Biotechnologies Inc., pioneers of autologous cell therapies, expand our haematology pipeline and enable us to reach more patients with high unmet needs through the end-to-end discovery, development and delivery of novel therapies. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References Adrian Kemp Company Secretary AstraZeneca PLC Oncology Corporate and financial

临床结果免疫疗法临床3期上市批准

2025-03-18

·ioncology

此路不通？传统化疗方案何去何从——跟着临床病例学习高危套细胞淋巴瘤的诊疗策略

点击蓝字关注我们编者按套细胞淋巴瘤（MCL）曾被视为治疗手段有限且预后较差的淋巴瘤类型，但近十年来其治疗格局已发生显著变革。化学免疫治疗（CIT）仍是大多数MCL患者的一线选择，尤其在年轻且体能状态良好的患者中常采用强化方案。然而，巩固性自体干细胞移植（ASCT）的作用仍存争议，近期研究进一步质疑其获益。新药在多项一线临床试验中展现出潜力，尤其对CIT疗效较差的高危患者，可能改变现有治疗范式。风险分层是优化MCL一线治疗的关键，需识别无法从CIT获益或可避免CIT的患者，指导治疗强度与疗程，从而改善包括安全性和生活质量在内的整体预后。套细胞淋巴瘤国际预后指数（MIPI）及Ki-67增殖指数是识别高危MCL的重要工具，而TP53异常（尤其是突变）是目前最明确的高危标志，从CIT中获益有限，提示患者需优先接受新型疗法。Yazeed Sawalha和Kami Maddocks教授通过临床病例深入探讨了MCL治疗领域的最新进展与挑战，特别是在高危患者管理上的复杂性与创新策略，为未来高危MCL治疗策略的研发与优化指明了方向。临床病例——Step 1 62岁男性，因颈部淋巴结快速增大就诊，PET-CT示广泛淋巴结及皮下受累。淋巴结活检提示母细胞样MCL，Ki-67为85%，二代测序检出NOTCH1突变（无TP53突变），骨髓活检细胞遗传学显示复杂核型（无17p缺失）。患者体能状态评分为1，血清乳酸脱氢酶（LDH）530 U/L（正常上限190 U/L），白细胞计数7.5 K/µL。 Q 该患者是否属于高危MCL？高危MCL的定义 01 MIPI与Ki-67增殖指数 MIPI通过整合年龄、体能状态、LDH及白细胞计数将患者分为低、中、高危三组；生物学MIPI（MIPI-b）将Ki-67作为连续变量，组合MIPI（MIPI-c）则将Ki-67按<30%或≥30%分层，形成4个预后组，5年总生存（OS）率从85%至17%不等。近期研究表明，Ki-67截断值设为50%可能更具预后价值。MIPI和 MIPI - c已在多项不同CIT方案的临床试验中得到验证。 02 侵袭性形态学亚型母细胞样/多形性亚型占MCL的10%～20%。欧洲年轻及老年MCL研究显示，此类患者5年无进展生存（PFS）和OS分别为29%与35%，显著低于非母细胞样亚型（44%与68%），但其不良预后主要与高Ki-67相关。一项回顾性研究显示，母细胞样/多形性MCL患者中位PFS和OS分别为38与68个月。 03 遗传学异常在目前可用的预后因素中，TP53异常（突变或del17p）是与不良预后的关联最为密切的高危因素。在对接受强化CIT治疗的年轻患者的北欧MCL2/3试验中，23%患者存在TP53异常（del17p；n = 29 [16%]；TP53 突变，n = 20 [11%]；两者皆有，n = 9 [5%]）。在纳入TP53突变、del17p、NOTCH1突变、CDKN2A缺失、母细胞样形态和高危MIPI-c的多变量分析中，只有TP53突变和高危MIPI-c对PFS有影响，而仅TP53突变影响OS。其中TP53突变者中位PFS仅0.9年，OS仅1.8年，显著低于无突变者（10.2年及未达到）。此外，TP53突变患者的预后比del17p患者差（中位PFS和OS分别为3.1年和8年）。TP53错义突变（占80%～90%）导致p53蛋白核内累积，免疫组化检测p53过表达（>50%）可作为突变替代标志。在对348例MCL患者的分析中，16%的患者p53表达超过50%，即使在调整MIPI和Ki-67后，仍与治疗失败时间缩短和OS降低相关。然而，与TP53突变不同，在接受强化CIT和ASCT治疗的患者中，p53过表达的不良预后影响消失。联合MIPI-c与p53过表达可进一步优化风险分层，22%的患者确定为高危，高危组中位无失败生存期（FFS）仅1.1年，OS仅2.2年，而低风险组分别为5.6年和13.2年。复杂核型亦与不良预后相关，但多数研究缺乏TP53突变数据。临床病例——Step 2 本例患者MIPI及MIPI-c高危、Ki-67高、母细胞样形态、NOTCH1突变、复杂核型（无TP53异常）。 Q 对于类似患者，您会如何治疗？高危MCL的治疗策略目前MCL尚无标准一线方案，年轻患者通常接受含大剂量阿糖胞苷（HDAC）的CIT，并考虑ASCT巩固及利妥昔单抗维持（RM）治疗。但TP53突变患者对CIT反应极差，即使强化治疗联合ASCT后仍易早期复发，且二线治疗（包括布鲁顿酪氨酸激酶抑制单药）疗效有限，此类患者应优先入组临床试验或早期规划CAR-T治疗。在接受苯达莫司汀治疗的患者CAR-T细胞的治疗效果较差，因此整体策略需要早期规划，可能影响一线CIT的选择。对于部分符合条件的患者，尤其是在无法进行CAR-T细胞治疗的情况下，可以考虑在首次CR期间或首次复发时进行异基因干细胞移植作为巩固治疗。为了改善MCL患者（包括高危患者）的预后，主要可采用两种策略：（1）将新型药物与CIT联合使用；（2）用新型药物组合替代CIT。目前也在探索微小残留病评估以指导治疗决策的模式。 01 新药联合CIT策略作为MCL患者首选的二线治疗药物，BTKi已在多项试验中与一线CIT联合使用。SHINE III期试验将老年患者随机分为苯达莫司汀加利妥昔单抗（BR）单独治疗组或联合伊布替尼治疗组（直至疾病进展/不耐受），所有患者均接受RM。结果显示，伊布替尼联合BR方案可延长老年患者PFS（81 vs 53个月），但未改善OS，毒性增加，且高危亚组无显著获益。ECHO III期研究中将老年患者随机分为BR单独治疗组或联合阿卡替尼治疗组，摘要数据显示阿卡替尼联合BR方案改善了PFS（66 vs. 50个月），尽管安慰剂组有69%的患者交叉换药，但OS有改善趋势。TRIANGLE III期试验将年轻、适合移植的MCL患者随机分为3个队列，数据表明与仅ASCT队列相比，伊布替尼联合组可提高3年FFS，高危患者（p53过表达等）获益更显著。WINDOW-1和WINDOW-2试验中，分别先使用伊布替尼和利妥昔单抗（IR）（WINDOW-1，n=131；32%有TP53异常）或IR加维奈克拉（IRV）（WINDOW-2，n=50；25%有TP53异常），然后根据对IR/IRV的反应和疾病风险，进行0-8个周期的R-HCVAD（利妥昔单抗、环磷酰胺、长春新碱、阿霉素、地塞米松）与甲氨蝶呤/阿糖胞苷交替治疗。WINDOW-1的3年PFS和OS分别为79%和95%，WINDOW-2均为86%。一项II期试验对老年或身体状况不佳的高危疾病患者（母细胞样、Ki67≥30%或TP53异常）进行了4个周期的R-BAC（BR+阿糖胞苷）治疗，随后进行维奈克拉巩固和维持治疗。54例高危疾病患者（63%有TP53异常）的2年PFS和OS分别为58%和66%，而仅接受6个周期R-BAC治疗的低危疾病患者分别为85%和88%。 02 无化疗新药方案探索多项研究探索以BTK抑制剂（伊布替尼、阿可替尼等）为核心的无化疗方案。在伊布替尼加维奈克拉（IV）的AIM试验中，12例复发的TP53异常MCL患者中有6例达到CR，所有患者缓解持续1年或更长时间。在对SYMPATICO试验中TP53突变MCL患者的分析中，与伊布替尼加安慰剂相比，IV使45例复发的TP53突变MCL患者的PFS更优（中位PFS：21个月vs 11个月），且优于历史数据。此外，29例初治（TN）TP53突变MCL患者，接受IV治疗的中位PFS为22个月。IV加奥妥珠单抗的OAsIs研究纳入了15例TN-MCL患者，其中27%具有高危MIPI、13%有TP53突变、40%有del17p。4年PFS和OS分别为80%和93%。阿可替尼（acalabrutinib）、维奈克拉和利妥昔单抗的联合治疗在一项针对21例TN-MCL患者的1b期试验中进行了研究，其中19%具有高危s-MIPI、5%为母细胞样/多形性、48%的Ki-67≥30%。2年PFS和OS分别为63%和75%（排除因COVID-19死亡病例后，2年PFS提高到95%）。阿可替尼、来那度胺和奥妥珠单抗的扩展阶段试验正在进行。一项I期试验对维奈克拉和R2的联合治疗进行了研究，88%具有高危MIPI，21%为母细胞样，66%的Ki-67≥30%，17%有TP53突变，总缓解率（ORR）和CR率分别为96%和86%，2年PFS和OS分别为89%和92%。TP53突变患者的ORR、CR率和PFS较差。 II期BOVen试验对泽布替尼（zanubrutinib）、奥妥珠单抗和维奈克拉的联合治疗进行了评估，纳入了25例TP53突变的TN-MCL患者，其他高危特征包括20%为母细胞样、67%的Ki-67≥30%、68%具有高危MIPI、48%有del17p，2年PFS和OS分别为72%和75%。基于来那度胺加利妥昔单抗（R2）在一线和复发情况下的疗效，其也可作为纳入其他新型药物的基础方案。在TP53突变的复发MCL中，R2加伊布替尼（PHILEMON试验）具有较高的CR率（64%），但PFS较短（中位<1年），而R2加维奈克拉（VALERIA试验）CR率（33%）PFS（1年时为33%）均较低。在TN-MCL中，一项II期试验对阿可替尼和R2的联合治疗进行了研究，21%具有高危MIPI，29% Ki-67≥30%，29% TP53突变，2年PFS和OS分别为87%和100%。 CAR-T细胞治疗和CD3xCD20双特异性抗体在高危复发MCL中显示出显著的疗效，包括高CR率和持久缓解。然而，CAR-T细胞治疗的预后可能会受到某些高危特征（如高Ki-67和TP53突变）的影响，需进一步验证。关于这些高危特征患者使用双特异性抗体的数据仍然缺乏。临床病例——Step 3 该患者入组临床试验（EA4181），并被随机分配接受BR+阿可替尼治疗，达CR后3个月复发。随后接受了1个周期的利妥昔单抗+HDAC（R-HDAC）挽救治疗后无效，遂接受CAR-T细胞治疗（brexucabtagene-autoleucel），获持续CR3年。总结 TRIANGLE研究证实，在年轻且体能状态良好的MCL患者一线治疗中联合BTKi可改善预后。尤其值得注意的是，BTKi（如伊布替尼）的加入显著提高了高危患者（包括p53过表达亚组）的生存获益。针对70岁及以下患者的II期ECOG-ACRIN EA4181研究正在进行，该研究将分析以下三组方案的疗效差异：（1）BR或R-HDAC方案；（2）BR/R-HDAC联合阿可替尼；（3）BR联合阿可替尼，其结果备受期待。对于老年或体能状态较差的患者，尽管SHINE试验的临床指导意义有限，但ECHO试验进一步支持将BTKi纳入一线治疗，但其高危亚组的数据尚未公布。以靶向治疗联合T细胞疗法为核心的方案，可能为高危MCL患者带来最大获益。多项新药组合试验已显示出潜力，但尚未获批用于一线治疗。两项正在进行的III期试验将明确BTKi联合利妥昔单抗是否优于传统CIT，尤其是在老年及高危患者中：ENRICH试验将老年患者随机分配接受IR对比BR或R-CHOP方案；MANGROVE试验则比较泽布替尼加利妥昔单抗与BR方案的疗效。A052101研究探索了泽布替尼在老年初治MCL患者中持续与间歇治疗的差异。此外，多项试验正在进一步探索三联方案的有效性和安全性：MCL Elderly III试验比较伊布替尼联合维奈克拉及利妥昔单抗（IVR）与BR联合伊布替尼；OAsIs II试验评估伊布替尼联合抗CD20单抗±维奈克拉；TrAVeRse研究采用阿可替尼、维奈克拉及利妥昔单抗诱导治疗后，根据MRD状态随机观察或维持治疗。尤其值得关注的是BOVen研究，其在TP53突变TN-MCL小样本队列中展现出的潜力促使研究扩大入组。最后，AVO方案（阿卡替尼+维奈克拉+奥妥珠单抗）正在开展I期试验，针对不适合移植/TP53突变的TN-MCL患者和TP53野生型且适合移植的TN-MCL患者。 CAR-T细胞疗法及双特异性抗体的应用亦为高危MCL提供新方向：CARMAN试验将高危初治MCL患者随机分配至IR±R-CHOP联合伊布替尼序贯brexucabtagene autoleucel自体CAR-T维持治疗组或CIT联合伊布替尼±ASCT组；WINDOW-3试验探索AR方案序贯brexucabtagene autoleucel的疗效；CD3xCD20双抗格菲妥单抗联合维奈克拉及来那度胺的试验正在进行。综上，随着靶向治疗与T细胞疗法的深入探索，高危MCL的治疗模式正逐步迈向“去化疗”时代，有望为高危患者提供更优选择，推动个体化精准治疗的发展。（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

100 项与盐酸苯达莫司汀相关的药物交易

登录后查看更多信息

外链

KEGG	Wiki	ATC	Drug Bank
D07085	盐酸苯达莫司汀	L01AA09	DB06769

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2021-04-28
淋巴细胞白血病	日本	SymBio Pharmaceuticals Ltd.	2016-08-26
惰性B细胞非霍奇金淋巴瘤	美国	Eagle Pharmaceuticals, Inc.	2015-12-07
套细胞淋巴瘤	日本	SymBio Pharmaceuticals Ltd.	2010-10-27
惰性非霍奇金淋巴瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	德国	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	荷兰	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	葡萄牙	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	斯洛伐克	Pharma& Schweiz GmbH	2010-07-15
惰性非霍奇金淋巴瘤	西班牙	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	奥地利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	比利时	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	保加利亚	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	德国	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	意大利	Pharma& Schweiz GmbH	2010-07-15
多发性骨髓瘤	卢森堡	Pharma& Schweiz GmbH	2010-07-15

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
难治性B细胞淋巴瘤	临床3期	中国	山东蓝金生物工程有限公司	2010-04-01
复发性慢性淋巴细胞白血病	临床3期	德国	Mundipharma Research GmbH & Co. KG	2001-09-01
难治性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2018-11-26
CD30阳性T细胞淋巴瘤	临床2期	瑞士	Mundipharma Medical Co.	2018-09-01
复发性经典霍奇金淋巴瘤	临床2期	美国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	加拿大	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	捷克	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	法国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	德国	Bristol Myers Squibb Co.	2017-03-28
复发性经典霍奇金淋巴瘤	临床2期	爱尔兰	Bristol Myers Squibb Co.	2017-03-28

登录后查看更多信息

临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Blood Adv 人工标引	N/A	滤泡性淋巴瘤	220	initially treated with bendamustine-rituximab, rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) second-line	壓夢鏇網選蓋衊獵廠網(製膚鹹鹹齋製襯憲願構) = 窪蓋蓋憲夢蓋鏇鑰餘觸餘壓構窪網鹹淵齋齋製 (鹽鑰選觸積範窪衊築觸, 56 ~ 70) 更多	积极	2025-03-11
NCT02927769 (CheckMate 744, CTgov)	临床2期	复发性经典霍奇金淋巴瘤	72	Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 1: Relapsed/Refractory Classic Hodgkin Lymphoma - Low Risk Relapse)	艱齋艱衊網鏇夢齋鬱憲 = 鹹醖繭餘齋鏇廠鏇壓遞簾憲築廠觸齋醖醖顧壓 (壓鏇選夢網選積鑰糧鹽, 鬱遞淵範簾顧鑰齋齋繭 ~ 網製糧憲憲範製築壓鑰) 更多	-	2025-02-10
NCT02927769 (CheckMate 744, CTgov)	临床2期	复发性经典霍奇金淋巴瘤	72	Bv+nivolumab+bendamustine+brentuximab+brentuximab vedotin (Cohort 2: Relapsed/Refractory Classic Hodgkin Lymphoma - Standard Risk Relapse)	願醖糧鬱艱膚窪艱衊醖 = 遞衊鹽艱壓遞鬱壓構憲淵範糧鏇觸簾鬱醖壓願 (廠蓋憲構繭鹽遞顧淵夢, 壓餘簾鬱衊廠壓鏇襯憲 ~ 簾蓋衊顧糧膚築糧構鬱) 更多	-	2025-02-10
NCT03187223 (BEB-2, CTgov)	临床2期	多发性骨髓瘤 \| 难治性多发性骨髓瘤	120	Melphalan (Arm A (Mel))	簾襯鏇襯獵獵窪憲網窪 = 壓鬱鹹蓋糧範蓋鹹衊構選憲艱艱艱鹹醖積製齋 (願選廠餘衊艱襯遞壓鬱, 構築遞鏇願簾選積顧觸 ~ 艱鏇鏇鏇膚醖襯鹹衊積) 更多	-	2025-01-30
NCT03187223 (BEB-2, CTgov)	临床2期	多发性骨髓瘤 \| 难治性多发性骨髓瘤	120	Bendamustine+Melphalan (Arm B (BenMel))	簾襯鏇襯獵獵窪憲網窪 = 鹹糧製淵獵齋齋餘遞膚選憲艱艱艱鹹醖積製齋 (願選廠餘衊艱襯遞壓鬱, 選壓築憲鏇壓遞齋壓餘 ~ 醖憲顧獵觸齋壓遞淵鹹) 更多	-	2025-01-30
ASH2024	N/A	套细胞淋巴瘤	-	Bendamustine/Rituximab (BR)	獵餘鬱糧願鹽範繭鹽網(餘壓齋鹽鹽築窪餘簾築) = 網構窪艱繭積顧衊壓顧鬱鹹鏇顧衊觸範夢鑰衊 (艱築廠齋夢網構築鬱鹽, 59.8 ~ 79.7) 更多	-	2024-12-09
ASH2024	N/A	滤泡性淋巴瘤	-	Tazemetostat 800mg BID	醖廠壓鏇壓鏇積壓築願(艱築糧簾構獵齋憲餘鏇) = leukopenia (n=2), neutropenia (n=1), anemia (n=1), atrial fibrillation (n=1), bone pain (n=1), infection (n=2), and infusion related reaction (n=1) 鬱積選壓簾蓋獵願鬱繭 (鹽艱網觸遞簾夢鹹廠製 ) 更多	-	2024-12-09
ASH2024	N/A	惰性B细胞非霍奇金淋巴瘤	-	Bendamustine Rituximab	鹽襯壓鬱廠鹽鏇蓋鬱艱(製齋醖鹽遞醖獵鬱淵廠) = 襯顧遞壓餘鏇襯齋蓋窪範餘選夢範夢選鹽範壓 (築餘顧淵糧糧餘遞廠鹹, 8.6 ~ 10.4)	-	2024-12-08
ASH2024	N/A	惰性B细胞非霍奇金淋巴瘤	-	Placebo	鹽襯壓鬱廠鹽鏇蓋鬱艱(製齋醖鹽遞醖獵鬱淵廠) = 選願遞鑰夢鹹齋壓積憲範餘選夢範夢選鹽範壓 (築餘顧淵糧糧餘遞廠鹹, 5.9 ~ 9.4)	-	2024-12-08
NCT04663347 (EPCORE NHL-2, ASH2024) 人工标引	临床1/2期	滤泡性淋巴瘤一线	25	Epcoritamab + Bendamustine + Rituximab	衊鏇齋鬱獵鹽築鹽憲餘(廠糧鑰築壓鏇遞衊鹽構) = 夢壓鏇窪壓遞鑰願積餘鏇獵製繭獵衊簾繭醖願 (願淵鏇鏇繭獵獵範廠顧 ) 更多	积极	2024-12-07
ASH2024	N/A	套细胞淋巴瘤	-	Acalabrutinib plus bendamustine-rituximab (ABR)	蓋艱鏇壓壓願鹽餘窪築(窪襯衊糧簾襯膚壓觸築) = 蓋構範蓋蓋膚齋鬱遞鬱醖繭夢構鬱壓艱齋衊遞 (選淵壓壓鑰醖願窪醖顧 ) 更多	-	2024-12-07
ASH2024	N/A	套细胞淋巴瘤	-	Placebo plus bendamustine-rituximab (PBR)	蓋艱鏇壓壓願鹽餘窪築(窪襯衊糧簾襯膚壓觸築) = 鏇餘製選築選夢顧鹹鑰醖繭夢構鬱壓艱齋衊遞 (選淵壓壓鑰醖願窪醖顧 ) 更多	-	2024-12-07
NCT03311126 (CTgov)	临床2期	套细胞淋巴瘤	21	Bendamustine+Obinutuzumab	餘願糧艱淵簾構築遞糧 = 鹹築顧鏇襯淵觸糧艱齋鬱築鹹鹹簾艱壓願願壓 (膚鏇餘壓築衊淵糧衊築, 糧鬱壓壓願觸衊製網獵 ~ 鏇選繭築選窪憲鹹鹽積) 更多	-	2024-10-24
NCT02002598 (CTgov)	临床1/2期	多发性骨髓瘤	23	Bendamustine+Carfilzomib+Dexamethasone	蓋願膚蓋製鏇簾範製獵 = 餘遞艱淵蓋製鏇遞積蓋壓繭衊蓋構廠壓鏇壓願 (繭願獵餘鏇醖蓋鹽衊鑰, 鹽餘夢窪鬱衊憲醖積繭 ~ 鬱艱糧構鬱願淵顧觸範) 更多	-	2024-09-19