Steven M Horwitz, Tatyana A Feldman, Jing Christine Ye, Michael S Khodadoust, Javier Munoz, Paul A Hamlin, Youn H Kim, Ryan A Wilcox, Manish R Patel, Greg Coffey, Alison Innes, Andreas Betz, Jaymes Holland, Cristina B Guzman, Sonali M Smith
{"title":"cerdulatinib是一种双脾酪氨酸激酶/janus激酶抑制剂,用于复发/难治性外周t细胞淋巴瘤的开放标签2a期研究结果。","authors":"Steven M Horwitz, Tatyana A Feldman, Jing Christine Ye, Michael S Khodadoust, Javier Munoz, Paul A Hamlin, Youn H Kim, Ryan A Wilcox, Manish R Patel, Greg Coffey, Alison Innes, Andreas Betz, Jaymes Holland, Cristina B Guzman, Sonali M Smith","doi":"10.1080/10428194.2025.2455489","DOIUrl":null,"url":null,"abstract":"<p><p>In this phase-2a study (NCT01994382), patients aged ≥18 years with relapsed/refractory peripheral T-cell lymphoma (PTCL; angioimmunoblastic T-cell lymphoma/T follicular helper [AITL/TFH], <i>n</i> = 29); PTCL-not otherwise specified [NOS], <i>n</i> = 11; and Other, <i>n</i> = 25) received 30 mg oral cerdulatinib, a reversible dual inhibitor of spleen tyrosine kinase and Janus kinase, twice daily in 28-day cycles until disease progression or unacceptable toxicity. Overall response rate (ORR) was 36.2% (12 complete responses [CR],9 partial responses [PR], and 14 stable disease); median time to response was 1.9 months. ORR was 51.9% for AITL/TFH (10 CR, 4 PR) and 31.8% for Other (2 CR, 5 PR); median duration of response was 12.9 and 5.3 months, respectively. The most common grade ≥3 treatment-emergent adverse events were asymptomatic amylase elevation (23.1%), anemia (20.0%), and asymptomatic lipase elevation (18.5%). These data suggest clinical activity and acceptable tolerability for cerdulatinib in patients with relapsed/refractory PTCL.</p>","PeriodicalId":18047,"journal":{"name":"Leukemia & Lymphoma","volume":" ","pages":"1100-1110"},"PeriodicalIF":2.2000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Results from an open-label phase 2a study of cerdulatinib, a dual spleen tyrosine kinase/janus kinase inhibitor, in relapsed/refractory peripheral T-cell lymphoma.\",\"authors\":\"Steven M Horwitz, Tatyana A Feldman, Jing Christine Ye, Michael S Khodadoust, Javier Munoz, Paul A Hamlin, Youn H Kim, Ryan A Wilcox, Manish R Patel, Greg Coffey, Alison Innes, Andreas Betz, Jaymes Holland, Cristina B Guzman, Sonali M Smith\",\"doi\":\"10.1080/10428194.2025.2455489\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In this phase-2a study (NCT01994382), patients aged ≥18 years with relapsed/refractory peripheral T-cell lymphoma (PTCL; angioimmunoblastic T-cell lymphoma/T follicular helper [AITL/TFH], <i>n</i> = 29); PTCL-not otherwise specified [NOS], <i>n</i> = 11; and Other, <i>n</i> = 25) received 30 mg oral cerdulatinib, a reversible dual inhibitor of spleen tyrosine kinase and Janus kinase, twice daily in 28-day cycles until disease progression or unacceptable toxicity. Overall response rate (ORR) was 36.2% (12 complete responses [CR],9 partial responses [PR], and 14 stable disease); median time to response was 1.9 months. ORR was 51.9% for AITL/TFH (10 CR, 4 PR) and 31.8% for Other (2 CR, 5 PR); median duration of response was 12.9 and 5.3 months, respectively. The most common grade ≥3 treatment-emergent adverse events were asymptomatic amylase elevation (23.1%), anemia (20.0%), and asymptomatic lipase elevation (18.5%). These data suggest clinical activity and acceptable tolerability for cerdulatinib in patients with relapsed/refractory PTCL.</p>\",\"PeriodicalId\":18047,\"journal\":{\"name\":\"Leukemia & Lymphoma\",\"volume\":\" \",\"pages\":\"1100-1110\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-06-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Leukemia & Lymphoma\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/10428194.2025.2455489\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/2/8 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q3\",\"JCRName\":\"HEMATOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Leukemia & Lymphoma","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/10428194.2025.2455489","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/2/8 0:00:00","PubModel":"Epub","JCR":"Q3","JCRName":"HEMATOLOGY","Score":null,"Total":0}
引用次数: 0
摘要
在这项2a期研究(NCT01994382)中,年龄≥18岁的复发/难治性外周t细胞淋巴瘤(PTCL;血管免疫母细胞T细胞淋巴瘤/T滤泡辅助细胞[AITL/TFH], n = 29);ptcl -未另行指定[NOS], n = 11;另一组(n = 25)接受30 mg口服cerdulatinib(一种可逆的脾酪氨酸激酶和Janus激酶的双重抑制剂),每天两次,28天为一个周期,直到疾病进展或不可接受的毒性。总缓解率(ORR)为36.2%(12例完全缓解[CR],9例部分缓解[PR], 14例病情稳定);中位缓解时间为1.9个月。AITL/TFH (10 CR, 4 PR)的ORR为51.9%,Other (2 CR, 5 PR)的ORR为31.8%;中位缓解持续时间分别为12.9个月和5.3个月。最常见的≥3级治疗不良事件是无症状淀粉酶升高(23.1%)、贫血(20.0%)和无症状脂肪酶升高(18.5%)。这些数据表明,cerdulatinib在复发/难治性PTCL患者中的临床活性和可接受的耐受性。
Results from an open-label phase 2a study of cerdulatinib, a dual spleen tyrosine kinase/janus kinase inhibitor, in relapsed/refractory peripheral T-cell lymphoma.
In this phase-2a study (NCT01994382), patients aged ≥18 years with relapsed/refractory peripheral T-cell lymphoma (PTCL; angioimmunoblastic T-cell lymphoma/T follicular helper [AITL/TFH], n = 29); PTCL-not otherwise specified [NOS], n = 11; and Other, n = 25) received 30 mg oral cerdulatinib, a reversible dual inhibitor of spleen tyrosine kinase and Janus kinase, twice daily in 28-day cycles until disease progression or unacceptable toxicity. Overall response rate (ORR) was 36.2% (12 complete responses [CR],9 partial responses [PR], and 14 stable disease); median time to response was 1.9 months. ORR was 51.9% for AITL/TFH (10 CR, 4 PR) and 31.8% for Other (2 CR, 5 PR); median duration of response was 12.9 and 5.3 months, respectively. The most common grade ≥3 treatment-emergent adverse events were asymptomatic amylase elevation (23.1%), anemia (20.0%), and asymptomatic lipase elevation (18.5%). These data suggest clinical activity and acceptable tolerability for cerdulatinib in patients with relapsed/refractory PTCL.
期刊介绍:
Leukemia & Lymphoma in its fourth decade continues to provide an international forum for publication of high quality clinical, translational, and basic science research, and original observations relating to all aspects of hematological malignancies. The scope ranges from clinical and clinico-pathological investigations to fundamental research in disease biology, mechanisms of action of novel agents, development of combination chemotherapy, pharmacology and pharmacogenomics as well as ethics and epidemiology. Submissions of unique clinical observations or confirmatory studies are considered and published as Letters to the Editor