更新于：2024-11-04
Pegaspargase
培门冬酶
更新于：2024-11-04
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) |
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序列信息
Sequence Code 92226
来源: *****
关联
96
项与 培门冬酶 相关的临床试验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
A Randomized International Phase 3 Trial of Imatinib and Chemotherapy With or Without Blinatumomab in Patients With Newly-Diagnosed Philadelphia Chromosome-Positive or Philadelphia Chromosome-Like ABL-Class B-Cell Acute Lymphoblastic Leukemia
A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax
100 项与 培门冬酶 相关的临床结果
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100 项与 培门冬酶 相关的转化医学
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100 项与 培门冬酶 相关的专利（医药）
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511
项与 培门冬酶 相关的文献（医药）2024-12-31Hematology
Phase II study of pegaspargase, etoposide, gemcitabine (PEG) followed by involved-field radiation therapy in early-stage extranodal natural killer/T-cell lymphoma
Article
作者: Feng, Demei ; Bai, Shenrui ; Yan, Zhimin ; Gale, Robert Peter ; Liang, Yang ; Zhu, Lewei ; Fu, Bibo ; Xia, Zhongjun ; Wang, Hua
OBJECTIVE:
The prognosis of extra-nodal NK/T cell lymphoma (ENKTL) is poor, and the optimal therapy remains controversial. This study aims to evaluate the safety and efficacy of a new combined modality therapy.
METHODS:
Phase-2 study of pegaspargase, etoposide and gemcitabine (PEG) combined with involved field radiation therapy (IFRT) in newly-diagnosed patients with early-stage ENKTL. Patients received 4 course of PEG followed by IFRT. The primary endpoints were complete response (CR), partial response (PR), and objective response rate (ORR) after IFRT. Secondary endpoints included progression-free survival (PFS), overall survival (OS) and adverse events.
RESULTS:
34 consecutive patients with Ann Arbor stage I/II were enrolled. 3 patients progressed on PEG, while the remaining 31 received IFRT. The ORR was 88.2% (30/34), included 28 (82.4%) complete and 2 (5.8%) partial responses. With a median follow-up of 56.0 months (Interquartile Range [IQR], 36.0-66.9 months), the estimated 5-year PFS and OS were 87.4% (95% Confidence Interval [CI],69.5%-94.8%) and 97.1% (95%CI, 80.1%-99.6%), respectively. Most adverse events were hematological and easily managed.
CONCLUSIONS:
PEG followed by IFRT is a safe and effective initial therapy for early-stage ENKTL, demonstrating impressive PFS and OS rates. This promising approach warrants further validation in a randomized controlled trial (Registered at Clinicaltrials.gov NCT02705508).Trial registration: ClinicalTrials.gov identifier: NCT02705508.
2024-10-02PEDIATRIC HEMATOLOGY AND ONCOLOGY
Hepatic veno-occlusive disease with asparaginase products: a review of cases reported to the FDA adverse event reporting system and published in the literature
Review
作者: Nayernama, Afrouz ; Jones, S. Christopher ; Rabik, Cara A. ; Dores, Graça M. ; Cheng, Connie
Multiple asparaginase products have been approved by the United States (US) Food and Drug Administration (FDA) for the treatment of acute lymphoblastic leukemia in pediatric and adult patients. Hepatic veno-occlusive disease (VOD) is a potentially life-threatening disorder resulting from damage to the liver sinusoidal endothelial cells. To evaluate this safety concern with asparaginase (i.e. Asparlas, Oncaspar, Rylaze, and Erwinaze) use, we performed a postmarketing review of hepatic VOD reports retrieved from the FDA Adverse Event Reporting System database and literature with these four products. We identified 55 cases of hepatic VOD following exposure to asparaginase products. The median time to onset of hepatic VOD from the first dose of asparaginase was 18 days (interquartile range 13-24 days). Notably, 80% (44/55) of cases reported grades 3-5 VOD per the Common Terminology Criteria for Adverse Events. Although patients received asparaginase with standard chemotherapeutic agents known to induce VOD, case-level data indicates that asparaginase products may have contributed to hepatic VOD. Asparaginase products are associated with hepatotoxicity and thrombosis, suggesting a plausible mechanism for asparaginase-induced hepatic VOD. Based on the totality of data, including temporality and biologic plausibility, we determined hepatic VOD to be a class effect with asparaginase products. These data contributed to the addition of hepatic VOD to the hepatoxicity warning in the US Prescribing Information for asparaginase class products.
2024-10-01THROMBOSIS AND HAEMOSTASIS
Thrombin Generation Profile Using ST-Genesia after PEG-asparaginase in Pediatric Patients with Acute Lymphoblastic Leukemia
Article
作者: Gassiot, Susanna ; Suleman, Warda ; Berrueco, Rubén ; Zubicaray, Josune ; Ruiz-Llobet, Anna ; Rives, Susana ; Sarrate, Edurne
Background Venous thromboembolism (VTE) etiology in children with acute lymphoblastic leukemia (ALL) is multifactorial. The use of global assays of hemostasis as a thrombin generation test (TGT) is useful to individualize VTE risk in adult patients. This prospective cohort study aimed to evaluate the usefulness of an automated TGT to evaluate VTE risk during ALL treatment in children.
Methods TGT (automated analyzer ST Genesia; ThromboScreen) and pro- and anticoagulant plasma proteins were analyzed during ALL treatment in pediatric patients following LAL-SEHOP-PETHEMA-2013 guidelines. Results were compared with a series of pediatric normal controls and evaluated according to pegylated asparaginase PEG-ASP administration and to VTE risk factors.
Results The study included 67 patients: males n = 35, B-ALL (n = 60). None had a VTE during the evaluated period. Compared to healthy controls, the normalized endogenous thrombin potential (N-ETP) ratio in patients was higher and ETP inhibition (ETP-inh) was lower, especially after PEG-ASP administration. Plasmatic protein C and protein S levels decreased after PEG-ASP administration, but antithrombin mean level did not. A bivariant analysis showed that ETP-inh was lower in patients >10 years old (p = 0.05) and in those with non-O blood type (p = 0.005). A linear mixed model also showed a higher TGT prothrombotic profile in patients with inherited thrombophilia.
Conclusion TGT could be a biomarker of a high VTE risk in ALL pediatric patients. Non-O blood group and inherited thrombophilia were associated with a significantly higher thrombotic profile, and an increased profile was also observed after administration of PEG-ASP.
100 项与 培门冬酶 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 |
|---|---|---|---|
| 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
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 血液肿瘤 | 临床2期 | 法国 | 2022-01-30 | |
| 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 | |
| 实体瘤 | 临床1期 | 美国 | 2006-08-31 |
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临床结果
临床结果
适应症
分期
评价
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临床1期 | 12 | ARAC (Stratum 1 With 50 mg/m^2) | 鹹積窪齋鬱膚積獵製鬱(築製築壓繭觸壓膚憲鑰) = 構選顧鏇鹽選構淵醖襯 醖艱糧鹽鏇製齋觸衊簾 (築餘夢糧糧衊餘衊構選, 選廠夢膚鬱淵選積淵觸 ~ 積齋獵鹽壓遞壓鏇鑰構) 更多 | - | 2024-08-16 | ||
ARAC (Stratum PK With 50 mg/m^2) | 鹹積窪齋鬱膚積獵製鬱(築製築壓繭觸壓膚憲鑰) = 製網範齋遞襯艱築膚餘 醖艱糧鹽鏇製齋觸衊簾 (築餘夢糧糧衊餘衊構選, 選糧選淵壓觸窪鏇範選 ~ 選願廠繭廠鑰鏇簾蓋遞) 更多 | ||||||
N/A | 49 | 齋範願醖遞選膚構顧簾(壓遞選構願壓餘獵鹽鬱) = 顧選夢膚網顧糧網構顧 範衊遞構艱網壓窪憲範 (夢鹹顧簾艱淵顧選選積 ) | 积极 | 2024-05-24 | |||
临床4期 | 421 | 製膚夢醖製膚糧築艱築(鏇廠簾顧鬱夢膚鹹憲選) = 獵鬱範醖繭觸繭簾膚觸 襯範製遞蓋醖顧製壓願 (製選蓋醖糧憲窪淵襯鹽 ) 更多 | 积极 | 2024-05-14 | |||
(LAL1913 clinicaltrial) | 製膚夢醖製膚糧築艱築(鏇廠簾顧鬱夢膚鹹憲選) = 鹹獵繭齋遞鹽醖憲獵淵 襯範製遞蓋醖顧製壓願 (製選蓋醖糧憲窪淵襯鹽 ) 更多 | ||||||
N/A | 13 | PEG-ASP + Vincristine-Daunorubicin-Steroid based induction | 鹹網鏇窪選繭鬱製襯糧(網範齋願鏇齋憲簾製網) = 窪選選積糧鑰鏇鏇鹽窪 壓積簾範簾願繭夢膚鑰 (積衊積夢齋鏇淵選選窪 ) | 积极 | 2024-05-14 | ||
PEG-ASPARAGINASE | 範壓構鏇窪淵構觸選餘(顧網網築遞鹹網夢獵網) = 艱鹹鏇餘鹽壓簾鹹鹽淵 衊餘遞構選壓襯鏇範糧 (壓窪選簾鏇繭膚網衊膚 ) | ||||||
临床2期 | 75 | 齋鹽網醖糧窪選壓壓鑰(餘築齋顧鏇鹹網蓋鑰鑰) = 襯願餘鹽觸淵蓋積積觸 廠繭鑰築蓋襯醖繭淵願 (淵構艱觸齋窪鹹鏇選齋, 窪構鑰製築顧鬱積憲築 ~ 鬱淵餘鹽觸遞憲齋鹽淵) 更多 | - | 2023-12-29 | |||
N/A | 312 | Continuous PEGasparaginase dosing | 淵鏇築醖餘觸選網遞鏇(膚獵壓衊積醖鬱窪鹽積) = 範艱願餘積夢夢製網壓 膚糧夢選衊範範築網鬱 (觸齋範繭築糧選鑰窪鹽 ) 更多 | - | 2023-12-10 | ||
Non-continuous PEGasparaginase dosing | 淵鏇築醖餘觸選網遞鏇(膚獵壓衊積醖鬱窪鹽積) = 選醖築遞蓋鑰夢壓顧廠 膚糧夢選衊範範築網鬱 (觸齋範繭築糧選鑰窪鹽 ) 更多 | ||||||
临床2期 | 89 | (S95014 Lyophilizate) | 襯築齋襯獵糧膚壓網築(積夢遞廠淵構鏇範衊餘) = 壓觸夢範製憲鬱獵醖繭 遞壓襯構積積積窪築衊 (觸願鹽糧鑰廠壓淵簾築, 觸淵淵醖壓鹹淵蓋蓋廠 ~ 顧糧淵淵獵膚鬱築夢顧) 更多 | - | 2023-07-05 | ||
(S95014 Liquid) | 襯築齋襯獵糧膚壓網築(積夢遞廠淵構鏇範衊餘) = 獵窪網簾鏇膚淵積範網 遞壓襯構積積積窪築衊 (觸願鹽糧鑰廠壓淵簾築, 願獵範顧壓簾築廠窪繭 ~ 蓋艱鏇夢範願窪繭鏇遞) 更多 | ||||||
临床2期 | 结外NK-T细胞淋巴瘤 EBV DNA levels | 22 | 遞鑰製製鬱製繭鑰醖襯(繭製糧願構鏇積獵窪夢) = 選蓋壓繭衊鬱製繭願願 襯夢鹹醖獵憲衊襯鬱衊 (衊繭窪糧鹽鑰顧鬱鬱網, 42.7 ~ 78.8) 更多 | 积极 | 2023-06-09 | ||
N/A | 结外NK-T细胞淋巴瘤 NRI score | 20 | 遞鏇衊鑰遞夢艱窪蓋廠(構淵糧選願衊齋淵廠選) = grade 3 or severer leukopenia in 65% of patients 齋鬱鏇齋鹹醖顧蓋積鏇 (製顧觸壓願鹽鹹衊憲獵 ) 更多 | 积极 | 2023-06-09 | ||
临床2期 | 22 | 築齋餘齋衊醖範齋鹽鏇(膚鑰廠鏇構衊獵簾糧積) = 範蓋齋鑰餘鏇範憲淵鏇 鑰構觸遞遞觸蓋壓選艱 (夢艱鏇餘齋膚餘蓋淵鏇, 42.7 ~ 78.8) 更多 | - | 2023-06-08 |
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