Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study
| العنوان: | Orelabrutinib for the treatment of relapsed or refractory MCL: a phase 1/2, open-label, multicenter, single-arm study |
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| المؤلفون: | Li-Juan Deng, Ke-Shu Zhou, Li-Hong Liu, Ming-Zhi Zhang, Zhi-Ming Li, Chun-Yan Ji, Wei Xu, Ting Liu, Bing Xu, Xin Wang, Su-Jun Gao, Hui-Lai Zhang, Yu Hu, Yan Li, Ying Cheng, Hai-Yan Yang, Jun-Ning Cao, Zunmin Zhu, Jian-Da Hu, Wei Zhang, Hong-Mei Jing, Kai-Yang Ding, Xiang-Yang Zhang, Renbin Zhao, Bin Zhang, Ya-Min Tian, Yong-Ping Song, Yu-Qin Song, Jun Zhu |
| المصدر: | Blood Advances. |
| بيانات النشر: | American Society of Hematology, 2023. |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Hematology |
| الوصف: | Relapsed or refractory (r/r) mantle cell lymphoma (MCL) is an aggressive B-cell malignancy with poor prognosis. Bruton's tyrosine kinase (BTK) is a mediator of B-cell receptor signaling and is associated with the development of B-cell lymphomas. Patients with r/r MCL were enrolled in this phase 1/2 study and treated with orelabrutinib, a novel, highly selective BTK inhibitor. The median number of prior regimens was two (range, 1 to 4). The median age was 62 years (range, 37 to 73 years). Eligible patients received oral orelabrutinib 150 mg once daily (n = 86) or 100 mg twice daily (n = 20) until disease progression or unacceptable toxicity. 150 mg once daily was chosen as the preferred RP2D. After a median follow-up of 23.8 months, the overall response rate was 81.1%, with 27.4% achieving complete response and 53.8% achieving partial response. The median duration of response and progression-free survival were 22.9 and 22.0 months, respectively. The median overall survival (OS) was not reached and the rate of OS at 24 months was 74.3%. Adverse events (AE) occurring in > 20% of patients were thrombocytopenia (34.0%), upper respiratory tract infection (27.4%), and neutropenia (24.5%). Grade ≥ 3 AE were infrequent and most commonly included thrombocytopenia (13.2%), neutropenia (8.5%), and anemia (7.5%). Three patients discontinued treatment due to treatment-related adverse events (TRAE) and no fatal TRAE were reported. Orelabrutinib showed substantial efficacy and was well tolerated in patients with r/r MCL. This trial was registered at www.clinicaltrials.gov as #NCT03494179. |
| تدمد: | 2473-9537 2473-9529 0349-4179 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_________::81459edf4e8140dcbb282d8e541815a4 https://doi.org/10.1182/bloodadvances.2022009168 |
| حقوق: | OPEN |
| رقم الأكسشن: | edsair.doi...........81459edf4e8140dcbb282d8e541815a4 |
| قاعدة البيانات: | OpenAIRE |
Full Text via ClinicalKey | تدمد: | 24739537 24739529 03494179 |
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