预约演示
更新于：2025-08-12
Pegaspargase
培门冬酶
更新于：2025-08-12
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1994-02-01), |
最高研发阶段(中国)- |
特殊审评孤儿药 (韩国) |
登录后查看时间轴
结构/序列
Sequence Code 92226
来源: *****
关联
139
项与 培门冬酶 相关的临床试验NCT05521087
A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations
NCT05700448
A Phase III, Randomized, Double-Blind, Multicenter Study of Sugemalimab (CS1001) Plus PGemOx Regimen Versus Placebo Plus PGemOx for Subjects With Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL)
NCT07072585
A Phase 2/3 Randomized Trial Investigating Daratumumab on a Modified Augmented BFM (aBFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LL)
100 项与 培门冬酶 相关的临床结果
登录后查看更多信息
100 项与 培门冬酶 相关的转化医学
登录后查看更多信息
100 项与 培门冬酶 相关的专利（医药）
登录后查看更多信息
517
项与 培门冬酶 相关的文献（医药）2025-10-01LEUKEMIA RESEARCH
DDGP-based chemoradiotherapy versus radiotherapy alone in newly diagnosed early-stage extranodal NK/T-cell lymphoma: A single-center retrospective analysis
Article
作者: Sun, Jinmiao ; Xie, Ziteng ; Zhang, Mingzhi ; Wang, Di ; Chang, Yu ; Zhang, Lei
To determine the optimal treatment for early-stage extranodal NK/T-cell lymphoma (ENKTL), the efficacy differences between chemoradiotherapy (CRT) and radiotherapy (RT) alone, and between sequential DDGP (dexamethasone, cisplatin, gemcitabine, and pegaspargase) followed by RT (DDGP+RT) versus RT followed by DDGP (RT+DDGP) were investigated. This study compared RT alone versus CRT using DDGP regimen in 189 early-stage ENKTL patients. CRT showed higher objective response rates (95.0% vs 88.0 %, P > 0.05) and significantly improved 10-year PFS (81.3 % vs 54.0 %, P < 0.001) and OS (91.4 % vs 87.3 %, P = 0.029) versus RT alone. DDGP followed by RT (DDGP+RT) achieved superior ORR (98.7 % vs 90.2 %, P = 0.043) and better 10-year PFS in patients with elevated β2-microglobulin (94.4 % vs 57.1 %, P = 0.025) compared to RT followed by DDGP. Multivariate analysis identified RT alone (HR=4.207, P＜0.001), and elevated LDH (HR=4.906, P = 0.012) as poor prognostic factors. CRT sequencing did not significantly affect survival outcomes. These findings demonstrate CRT's superiority over RT alone and suggest β2-MG may guide optimal treatment sequencing in early-stage ENKTL.
2025-08-01INTERNATIONAL JOURNAL OF HEMATOLOGY
Phase 2 multicenter study of pegaspargase in Japanese patients with previously untreated acute lymphoblastic leukemia
Article
作者: Kosaka, Yoshiyuki ; Horibe, Keizo ; Benettaib, Bouchra ; Maeda, Naoko ; Okamoto, Yasuhiro ; Tessier, Adrien ; Koh, Katsuyoshi ; Ogawa, Chitose ; Koga, Nobuhiro ; Shvenke, Yelena ; Hasegawa, Daisuke ; Zhu, Jian ; Ogawa, Atsushi ; Kobayashi, Ryoji
Abstract:
Pegaspargase is a pegylated formulation of E. coli-derived asparaginase, which when combined with multi-agent chemotherapy is an effective, well-established therapy for acute lymphoblastic leukemia (ALL). This study evaluated the efficacy, safety and pharmacokinetics of lyophilized pegaspargase in the Japanese population. The study had two parts; the primary endpoint for Part 1 was the incidence and nature of treatment-emergent adverse events (TEAEs), including those related to pegaspargase, to determine the number of patients who experience intolerable toxicity during a tolerability assessment period. The primary endpoint for Part 2 was the percentage of patients with plasma asparaginase activity of ≥ 0.1 IU/ml 14 days after administration of the first dose of lyophilized pegaspargase. All 26 patients included in the safety analysis experienced at least one TEAE. Frequently reported TEAEs related to lyophilized pegaspargase included decreases in blood fibrinogen, antithrombin III, white blood cell count, and platelet count. No deaths were reported. Plasma asparaginase activity reached ≥ 0.1 IU/ml 5 min after the first dose of lyophilized pegaspargase and was maintained for 14 days in all patients with evaluable samples. The results of this study show that lyophilized pegaspargase represents an effective and well-tolerated first-line treatment option in Japanese patients with ALL.
2025-07-15Pharmaceutics
Pharmacokinetics of Pegaspargase with a Limited Sampling Strategy for Asparaginase Activity Monitoring in Children with Acute Lymphoblastic Leukemia.
Article
作者: Rizzari, Carmelo ; Ceruti, Tommaso ; Porcu, Luca ; Zucchetti, Massimo ; Provenzi, Massimo ; Parasole, Rosanna ; Colombini, Antonella ; Lo Nigro, Luca ; Schrappe, Martin ; Bertorello, Nicoletta ; Onofrillo, Daniela ; Bettini, Laura Rachele ; Fuso Nerini, Ilaria ; Matteo, Cristina ; Ubezio, Paolo ; Cancelliere, Marta ; Bungaro, Silvia ; Silvestri, Daniela ; Gotti, Giacomo ; Valsecchi, Maria Grazia ; Chiocca, Elena ; Vinti, Luciana
Background: Asparaginase (ASPase) plays an important role in the therapy of acute lymphoblastic leukemia (ALL). Serum ASPase activity (SAA) can be modified and even abolished by host immune responses; therefore, current treatment guidelines recommend to monitor SAA during treatment administration. The SAA monitoring schedule needs to be carefully planned to reduce the number of samples without hampering the possibility of measuring pharmacokinetics (PK) parameters in individual patients. Complex modelling approaches, not easily applicable in common practice, have been applied in previous studies to estimate ASPase PK parameters. This study aimed to estimate PK parameters by using a simplified approach suitable for real-world settings with limited sampling. Methods: Our study was based on 434 patients treated in Italy within the AIEOP-BFM ALL 2009 trial. During the induction phase, patients received two doses of pegylated ASPase and were monitored with blood sampling at five time points, including time 0. PK parameters were estimated by using the individually available SAA measurements with simple modifications of the classical non-compartmental PK analysis. We also took the opportunity to develop and validate a series of limited sampling models to predict ASPase exposure. Results: During the induction phase, average ASPase activity at day 7 was 1380 IU/L after the first dose and 1948 IU/L after the second dose; therapeutic SAA levels (>100 IU/L) were maintained until day 33 in 90.1% of patients. The average AUC and clearance were 46,937 IU/L × day and 0.114 L/day/m2, respectively. The database was analyzed for possible associations of PK parameters with biological characteristics of the patients, finding only a limited dependence on sex, age and risk score; however, these differences were not sufficient to allow any dose or schedule adjustments. Thereafter the possibility of further sampling reduction by using simple linear models to estimate the AUC was also explored. The most simple model required only two samplings 7 days after each ASPase dose, with the AUC being proportional to the sum of the two measured activities A(7) and A(21), calculated by the formula AUC = 14.1 × [A(7) + A(21)]. This model predicts the AUC with 6% average error and 35% maximum error compared to the AUC estimated with all available measures. Conclusions: Our study demonstrates the feasibility of a direct estimation of PK parameters in a real-life situation with limited and variable blood sampling schedules and also offers a simplified method and formulae easily applicable in clinical practice while maintaining a reliable pharmacokinetic monitoring.
100 项与 培门冬酶 相关的药物交易
登录后查看更多信息
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
登录
| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 淋巴瘤 | 日本 | 2023-06-26 | |
| 超敏反应 | 美国 | 2019-01-03 | |
| 急性淋巴细胞白血病 | 美国 | 1994-02-01 |
未上市
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 前体B细胞急性淋巴细胞白血病 | 临床3期 | 美国 | 2017-03-03 | |
| 前体B细胞急性淋巴细胞白血病 | 临床3期 | 加拿大 | 2017-03-03 | |
| 前体T淋巴细胞白血病淋巴瘤 | 临床3期 | 美国 | 2017-03-03 | |
| 前体T淋巴细胞白血病淋巴瘤 | 临床3期 | 加拿大 | 2017-03-03 | |
| 淋巴母细胞淋巴瘤 | 临床2期 | 美国 | 2012-06-01 | |
| 淋巴母细胞淋巴瘤 | 临床2期 | 加拿大 | 2012-06-01 | |
| 复发性儿童急性淋巴细胞白血病 | 临床1期 | 美国 | 2019-03-25 | |
| 复发难治性急性淋巴细胞白血病 | 临床1期 | 美国 | 2019-03-25 | |
| 难治性成人急性淋巴细胞白血病 | 临床1期 | 美国 | 2019-03-25 | |
| 非霍奇金淋巴瘤 | 临床1期 | 美国 | 2006-07-01 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 20 | Pegaspargase+Gemcitabine+Etoposide+Mitoxantrone hydrochloride liposome+Dexamethasone (P-GEMD) regimen | 憲範憲醖衊齋願鏇廠簾(鏇衊壓積艱選夢鹹網範) = 積選積齋選顧構簾網廠 鬱壓獵觸齋簾鑰願膚蓋 (繭憲衊遞蓋蓋糧鏇觸簾 ) 更多 | 积极 | 2025-05-14 | ||
N/A | 90 | PEG-ASP 1000 UI/m^2 | 鹹繭廠廠製積淵襯遞觸(衊衊夢觸餘餘餘鬱廠願) = Coagulopathy occurred in 26% of cases (grade ≥3, 6%), without significant differences in the 3 groups 膚廠鬱膚鬱夢鏇齋遞網 (築糧顧鹽願糧簾觸鹽糧 ) 更多 | - | 2025-05-14 | ||
临床2期 | 50 | 獵襯憲鹹獵獵築觸餘艱(顧壓鏇餘蓋鏇襯顧窪獵) = A better 5-year DFS was observed in patients ≤40 years (80%) when compared with those >40 (56%) 範遞淵構廠顧遞鏇構醖 (廠顧襯夢遞網築襯淵觸 ) 更多 | 积极 | 2025-05-14 | |||
High cumulative dose (HCD) steroids | |||||||
N/A | 2,032 | (Arm A (two-infusion scheme)) | 遞蓋醖製糧簾衊膚膚蓋(壓襯繭鏇襯構鹽廠觸衊) = 築憲簾憲窪範鬱齋淵衊 築積繭鹽艱鏇範網齋醖 (鑰鏇獵憲廠憲壓夢醖簾 ) | 积极 | 2024-12-08 | ||
(Arm B (one-infusion scheme)) | 遞蓋醖製糧簾衊膚膚蓋(壓襯繭鏇襯構鹽廠觸衊) = 網選艱觸憲構觸獵鏇糧 築積繭鹽艱鏇範網齋醖 (鑰鏇獵憲廠憲壓夢醖簾 ) | ||||||
N/A | - | Pegaspargase | 選糧窪壓衊鬱鹹齋鹽鏇(衊醖鏇蓋衊製膚觸鑰鏇) = 4% during the induction phase, 1 patient during the consolidation phase 鹽積壓獵襯繭淵齋淵餘 (簾遞觸鏇襯襯網淵製醖 ) 更多 | - | 2024-09-04 | ||
Erwinia asparaginase | |||||||
临床1期 | 12 | ARAC (Stratum 1 With 50 mg/m^2) | 顧鏇窪淵鹽遞網積蓋網 = 餘繭觸廠選鹽範繭醖餘 製蓋觸鹹獵夢夢遞願憲 (範獵夢憲構膚築積鑰鑰, 顧願構積糧夢鏇簾廠夢 ~ 衊鬱遞餘顧繭衊獵鹽願) 更多 | - | 2024-08-16 | ||
ARAC (Stratum PK With 50 mg/m^2) | 顧鏇窪淵鹽遞網積蓋網 = 膚顧鏇鏇構艱襯獵窪構 製蓋觸鹹獵夢夢遞願憲 (範獵夢憲構膚築積鑰鑰, 襯襯鬱襯願製窪艱夢築 ~ 鏇壓廠膚齋鑰廠廠願遞) 更多 | ||||||
N/A | 49 | 壓窪範憲夢繭鹹簾鏇襯(簾網鏇顧壓獵鏇艱衊夢) = 壓夢餘膚製襯繭鬱簾窪 選壓壓壓壓廠窪夢遞壓 (繭襯糧鏇築壓齋廠憲廠 ) | 积极 | 2024-05-24 | |||
临床4期 | 421 | 鹹顧積衊範繭構願範衊(製選鹽壓網淵積鬱糧積) = 蓋鏇顧鹽齋齋構蓋壓築 願繭壓選齋繭願遞壓構 (簾餘鹽願淵憲糧積膚廠 ) 更多 | 积极 | 2024-05-14 | |||
Pegaspargaseogram inspired to the GIMEMA LAL1913 clinical trial (Allogeneic stem cell transplantation (HSCT)) | 鹹顧積衊範繭構願範衊(製選鹽壓網淵積鬱糧積) = 憲憲鏇選鹹製鬱範衊齋 願繭壓選齋繭願遞壓構 (簾餘鹽願淵憲糧積膚廠 ) 更多 | ||||||
N/A | 13 | PEG-ASP + Vincristine-Daunorubicin-Steroid based induction | 廠選夢壓鹽鹽窪鹽壓餘(醖鹹夢觸蓋選鹹顧淵鏇) = 願壓鹽淵製齋憲糧膚窪 鏇鑰憲餘襯壓鏇鏇繭願 (鑰窪襯選餘鹹醖繭壓構 ) | 积极 | 2024-05-14 | ||
PEG-ASPARAGINASE (B ALL patients) | 遞獵鬱鑰鑰醖襯艱積簾(艱窪壓簾壓鹽網簾憲淵) = 鬱憲餘艱衊繭齋構鑰醖 遞憲鏇製製鹽膚壓襯鬱 (衊繭艱觸簾鏇鹽齋艱壓 ) | ||||||
临床2期 | 34 | 壓醖願鏇窪選簾製艱繭(簾膚壓糧範願餘觸築築) = 簾繭廠鬱積憲襯積鬱繭 淵繭築遞範蓋衊鏇鬱鏇 (願鑰願鹽範製顧壓窪願, 54 ~ 95) 更多 | 积极 | 2024-03-27 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
Eureka LS:
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用