预约演示
更新于：2026-07-15
Bendamustine Hydrochloride
盐酸苯达莫司汀
更新于：2026-07-15
概要
基本信息
药物类型 小分子化药 |
别名 BENDA、Bendam、Bendamus + [41] |
靶点 |
作用方式 抑制剂 |
作用机制 DNA抑制剂(DNA抑制剂) |
在研适应症 |
最高研发阶段批准上市 |
首次获批日期 美国 (2008-03-20), |
最高研发阶段(中国)批准上市 |
特殊审评孤儿药 (美国)、孤儿药 (日本)、优先审评 (中国) |
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结构/序列
分子式C16H22Cl3N3O2 |
InChIKeyZHSKUOZOLHMKEA-UHFFFAOYSA-N |
CAS号3543-75-7 |
关联
435
项与 盐酸苯达莫司汀 相关的临床试验NCT07575893
REACH-CD30: Reinduction Therapy Followed by Engineered Autologous CD30.CAR T Cells in Children, Adolescents and Young Adults With Lower-Risk CD30+ Relapsed Classical Hodgkin Lymphoma NYMC 628
NCT07593482
Bendamustine Versus Fludarabine/Cyclophosphamide for Lymphodepletion in CAR-T Therapy: a Randomized Trial
NCT07634471
A Phase 2/3 Randomized, Open-label Study of MK-1045 in Combination With Rituximab in Participants With 1L Follicular Lymphoma
100 项与 盐酸苯达莫司汀 相关的临床结果
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100 项与 盐酸苯达莫司汀 相关的转化医学
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100 项与 盐酸苯达莫司汀 相关的专利（医药）
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2,765
项与 盐酸苯达莫司汀 相关的文献（医药）2026-08-01ANALYTICA CHIMICA ACTA
A dual green chromatographic platform for bioanalytical quantification and pharmacokinetic characterization of the BBD antineoplastic regimen
Article
作者: Hemeda, Loah R ; Sharkawi, Marco M Z ; Zaki, Shimaa S ; Amin, Noha H ; Mohamed, Norhan R
Multiple myeloma (MM) is a hematological malignancy associated with high morbidity and mortality. The BBD salvage regimen, consisting of bendamustine (BEN), bortezomib (BOR), and dexamethasone (DEX), has demonstrated efficacy in patients with relapsed or refractory MM. However, no analytical method has been reported for the simultaneous determination of this regimen, and potential pharmacokinetic interactions among its components remain insufficiently explored. In this study, two environmentally friendly, sensitive, and rapid chromatographic methods were developed and validated for the simultaneous quantification of BEN, BOR, and DEX in rat plasma, using sildenafil (SIL) as an internal standard. The methods showed linearity over wide concentration ranges, along with satisfactory accuracy and precision, and were successfully applied to in vivo pharmacokinetic studies following individual and combined administration of the three drugs. The results revealed measurable changes in pharmacokinetic parameters, suggesting potential pharmacokinetic interactions among the components of the BBD regimen. The LC-MS/MS method provided higher sensitivity and selectivity, while the TLC-densitometric method offered a simpler and more environmentally friendly alternative for routine analysis. In addition, the environmental sustainability of the proposed methods was evaluated using multiple greenness assessment tools, confirming their eco-friendly profiles.
2026-07-01HEMATOLOGICAL ONCOLOGY
Bendamustine/Rituximab Induction Followed by Venetoclax/Rituximab Consolidation in Frontline Treatment of Chronic Lymphocytic Leukemia: A Phase 2 Multi‐Center Study
Article
作者: Bachow, Spencer Henick ; Viny, Aaron D. ; Lamanna, Nicole ; Lipsky, Andrew H. ; Hill, Brian T. ; Heaney, Mark L. ; Weissbrot, Hanna ; Winter, Allison ; Sender, Naomi ; Rosenblat, Todd L. ; Jurcic, Joseph
ABSTRACT:
We hypothesized that a time‐limited frontline treatment strategy with abbreviated chemoimmunotherapy followed by targeted consolidation could achieve durable disease control with manageable toxicity in CLL. We evaluated the safety and efficacy of short‐course bendamustine/rituximab (BR) induction followed by venetoclax/rituximab (VR) consolidation. In a multicenter, single‐arm Phase 2 trial (NCT03609593), previously untreated CLL/SLL needing therapy received BR for three 28‐day cycles followed by venetoclax ramp‐up to 400 mg daily plus rituximab every 28 days for six cycles; venetoclax continued to 12 cycles (total treatment, 15 months). The primary endpoint was overall response rate (ORR); key secondary endpoints included uMRD, PFS/OS, and safety per CTCAE v4. Forty‐two patients were enrolled (median age 61.5 years; 64% unmutated IGHV; 29% complex karyotype; 10% TP53 aberrancy); 93% completed all planned therapy. At end of treatment, ITT ORR was 86% (CR/CRi 64%, PR 21%); among efficacy‐evaluable patients, ORR was 100% (CR/CRi 75%). End‐of‐therapy uMRD was achieved by 83% in bone marrow and 84% in blood among efficacy‐evaluable patients. Three‐year PFS and OS were 87.5% and 92.7%. TLS risk was downstaged after BR, and no TLS events occurred. Febrile neutropenia occurred in 12% of patients. Two on‐study deaths due to COVID‐19 occurred; no Richter transformation occurred. Time‐limited BR‐VR achieved high uMRD rates and durable remissions with a manageable safety profile. While the treatment landscape in CLL has largely shifted toward chemotherapy‐free regimens, these data demonstrate the biological proof‐of‐concept that limited induction chemotherapy can effectively mitigate TLS risk and facilitate safe outpatient ramp‐up of venetoclax.
2026-07-01EUROPEAN JOURNAL OF HAEMATOLOGY
Pirtobrutinib at the Crossroads: Shaping Its Future Role in Chronic Lymphocytic Leukemia (
CLL
) Care
Review
作者: Molica, Stefano ; Allsup, David
ABSTRACT:
Covalent Bruton tyrosine kinase inhibitor (cBTKi)‐based regimens have redefined therapy for chronic lymphocytic leukemia (CLL). However, continuous treatment with BTKis can select for therapy resistance, typically associated with
BTK C481
mutations and fosfolipasi C gamma 2 (PLCγ2) activation. In addition, continuous BTKi therapy poses challenges for treatment interruptions and dose modifications, with implications for clinical outcomes. Pirtobrutinib, a highly selective, reversible (noncovalent) BTKi, inhibits BTK independently of C481 and maintains sustained target engagement. In patients with cBTKi‐pretreated relapsed/refractory (R/R) CLL, the BRUIN‐CLL‐321 trial demonstrated improved progression‐free survival (PFS) and time to next treatment (TTNT) compared with idelalisib/rituximab or bendamustine/rituximab, accompanied by a favorable tolerability profile. Data from randomized phase III BRUIN‐CLL‐313 and BRUIN‐CLL‐314 trials demonstrate the superiority of pirtobrutinib over chemoimmunotherapy in untreated patients and non‐inferiority to ibrutinib in untreated patients or in patients with R/R disease who had no prior exposure to cBTKis. These data are not sufficient to justify a change in clinical practice; however, they lay the groundwork for a potential future repositioning of pirtobrutinib from the treatment of R/R CLL to earlier lines of therapy. In this review, we address a range of current and prospective aspects of pirtobrutinib‐based therapies: (1) the strengths and limitations of the trial datasets; (2) the biological rationale for frontline noncovalent BTK inhibition; (3) sequencing trade‐offs; and (4) prospective scenarios, including combination strategies and time‐limited regimens.
100 项与 盐酸苯达莫司汀 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 复发性惰性非霍奇金淋巴瘤 | 澳大利亚 | 2026-06-25 | |
| 难治性惰性非霍奇金淋巴瘤 | 澳大利亚 | 2026-06-25 | |
| 弥漫性大B细胞淋巴瘤 | 日本 | 2021-04-28 | |
| 淋巴细胞白血病 | 日本 | 2016-08-26 | |
| 惰性B细胞非霍奇金淋巴瘤 | 美国 | 2015-12-07 | |
| 套细胞淋巴瘤 | 日本 | 2010-10-27 | |
| 惰性非霍奇金淋巴瘤 | 奥地利 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 比利时 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 保加利亚 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 德国 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 意大利 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 卢森堡 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 荷兰 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 葡萄牙 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 斯洛伐克 | 2010-07-15 | |
| 惰性非霍奇金淋巴瘤 | 西班牙 | 2010-07-15 | |
| 多发性骨髓瘤 | 奥地利 | 2010-07-15 | |
| 多发性骨髓瘤 | 比利时 | 2010-07-15 | |
| 多发性骨髓瘤 | 保加利亚 | 2010-07-15 | |
| 多发性骨髓瘤 | 德国 | 2010-07-15 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 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 | - | 2010-04-01 |
| 复发性慢性淋巴细胞白血病 | 临床3期 | 德国 | 2001-09-01 | |
| CD20阳性大B细胞淋巴瘤 | 临床2期 | 日本 | 2019-04-01 | |
| 难治性经典霍奇金淋巴瘤 | 临床2期 | 美国 | 2018-11-26 | |
| CD30阳性T细胞淋巴瘤 | 临床2期 | 瑞士 | 2018-09-01 | |
| 复发性经典霍奇金淋巴瘤 | 临床2期 | 美国 | 2017-03-28 | |
| 复发性经典霍奇金淋巴瘤 | 临床2期 | 加拿大 | 2017-03-28 | |
| 复发性经典霍奇金淋巴瘤 | 临床2期 | 捷克 | 2017-03-28 | |
| 复发性经典霍奇金淋巴瘤 | 临床2期 | 法国 | 2017-03-28 | |
| 复发性经典霍奇金淋巴瘤 | 临床2期 | 德国 | 2017-03-28 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床1/2期 | 65 | (Phase 1) | 網鏇顧簾鏇衊壓製獵艱 = 壓憲廠廠齋鹹糧繭鏇淵 網醖鏇餘憲齋積鏇餘餘 (簾範窪網醖遞淵憲遞憲, 艱餘淵築餘餘襯壓遞襯 ~ 觸糧鬱膚壓壓艱齋餘鬱) 更多 | - | 2026-06-24 | ||
(Phase 1: Brentuximab Vedotin 1.2 mg/kg, Bendamustine 70 mg/m^2) | 範艱製網製艱廠廠簾糧 = 鬱糧鬱製淵鏇獵製築餘 衊鹽窪糧顧夢膚網積觸 (窪鬱積襯夢窪簾簾網獵, 積夢壓觸獵鬱蓋壓選齋 ~ 構獵獵夢簾糧鏇網鬱糧) 更多 | ||||||
N/A | 巨球蛋白血症 MYD88 mutation - L265P | del-17p | 34 | RBBd therapy program | 艱壓簾窪憲構願膚憲衊(淵廠餘鹽遞糧醖鬱齋鬱) = 願鹽鬱壓糧觸壓構糧鏇 餘築簾積襯構鹽簾鑰鑰 (製糧艱艱鹹膚獵簾艱積 ) 更多 | 积极 | 2026-05-12 | |
N/A | 巨球蛋白血症 一线 | 54 | KCD-R | 製繭網鬱鑰衊壓觸夢夢(觸製願鬱廠鬱繭廠鏇窪) = 鏇衊築積簾衊觸積鹽鏇 艱艱醖繭齋壓顧鬱蓋糧 (範構簾夢糧鹹鏇選築簾 ) 更多 | 积极 | 2026-05-12 | |
製繭網鬱鑰衊壓觸夢夢(觸製願鬱廠鬱繭廠鏇窪) = 鬱淵鹽淵鹹觸選膚餘簾 艱艱醖繭齋壓顧鬱蓋糧 (範構簾夢糧鹹鏇選築簾 ) 更多 | |||||||
临床2期 | 27 | 簾簾壓醖顧鏇膚廠獵繭 = 齋憲構壓衊憲築膚顧夢 艱範觸餘獵鏇製廠築製 (淵醖壓願膚積獵夢糧鑰, 顧選構簾夢簾網網夢獵 ~ 齋襯鹽淵鏇艱獵憲襯網) 更多 | - | 2026-04-22 | |||
N/A | 634 | 網膚觸繭網觸壓築鏇構(膚鑰齋廠壓願觸製艱壓): RR = 0.93, P-Value = 0.5 更多 | 积极 | 2026-02-04 | |||
N/A | 套细胞淋巴瘤 一线 | 132 | 範糧繭鑰獵繭觸憲願膚(製觸顧製鬱繭選繭膚壓) = 遞獵選夢鬱膚範鏇膚簾 夢憲範製積構糧遞蓋網 (襯願鑰範鬱願遞鬱網築 ) 更多 | 积极 | 2025-12-06 | ||
範糧繭鑰獵繭觸憲願膚(製觸顧製鬱繭選繭膚壓) = 餘鬱築築遞願憲夢構繭 夢憲範製積構糧遞蓋網 (襯願鑰範鬱願遞鬱網築 ) 更多 | |||||||
N/A | 滤泡性淋巴瘤 centroblast | 129 | (SUVmax >12) | 願鹽襯鹽壓獵襯顧鹽鹹(廠蓋願糧鑰齋淵膚淵範) = 選鹽鏇衊壓衊膚夢夢淵 醖製廠餘鹽網齋簾觸繭 (簾選鬱鏇鑰鹽鹹淵艱鹽 ) | 积极 | 2025-12-06 | |
(TMTV >510cm3) | 願鹽襯鹽壓獵襯顧鹽鹹(廠蓋願糧鑰齋淵膚淵範) = 鹽糧淵醖膚膚糧艱鹽獵 醖製廠餘鹽網齋簾觸繭 (簾選鬱鏇鑰鹽鹹淵艱鹽 ) | ||||||
N/A | 634 | 網襯積壓鬱鏇鹽廠窪鹽(繭積繭夢網壓鬱遞膚齋): RR = 1.07 (95.0% CI, 0.99 ~ 1.16), P-Value = 0.09 更多 | 积极 | 2025-12-06 | |||
临床3期 | 1,575 | 鏇淵鹹獵簾醖積鹽簾衊(糧糧餘艱窪鏇鏇顧鬱鹹): HR = 0.62, P-Value = 0.27 更多 | 积极 | 2025-12-06 | |||
CHOP- or CVP-based immunochemotherapies | |||||||
N/A | 8 | BeGEV regimen | 夢築構膚齋網選顧齋壓(糧築膚夢衊糧構齋膚淵) = The most frequent BeGEV-related adverse event was grade 1-2 neutropenia (occurring in 2/8 patients, 25.0%). No bendamustine-related toxicities such as alopecia or peripheral neuropathy were observed. 醖糧鹹鏇窪網網築膚觸 (獵夢艱構鬱獵遞襯構觸 ) 更多 | 积极 | 2025-12-06 |
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