- 主题
- 381
- 您的身份
- 病友
- 就诊医院
- 北京协和
- 病理报告
- 滤泡性淋巴瘤1-2级
- 目前状态
- 康复10-20年
参加活动:0 次 组织活动:0 次
您的身份病友
病理报告滤泡性淋巴瘤1-2级
就诊医院北京协和
目前状态康复10-20年
最后登录2025-2-27
  
|
发表于 2020-7-21 15:46:08
|
显示全部楼层
来自: 中国北京
Phase I Trial of Venetoclax Plus R‐EPOCH in Aggressive B‐Cell Lymphoma
In a phase I trial, investigators examined the feasibility of combining venetoclax with dose‐adjusted EPOCH plus rituximab (DA‐EPOCH‐R) in patients with previously untreated aggressive B‐cell lymphomas. Sarah C. Rutherford, M.D., of Weill Cornell Medicine, presented the study results.
The phase I dose‐escalation trial enrolled 30 patients with newly diagnosed double‐hit lymphoma (n = 15), DLBCL (n = 9), transformed indolent NHL (n = 3), primary mediastinal B‐cell lymphoma (n = 2), and high grade B‐cell lymphoma not otherwise specified (n = 2). The primary study objectives were to identify the maximum tolerated dose (MTD) of venetoclax with DA‐EPOCH‐R and to determine the optimal dose for phase II trials.
The first cohort of patients (n = 18) received venetoclax according to different dosing levels (DLs), in addition to 6 cycles of DA‐EPOCH‐R:
DL1 (n = 3): venetoclax 400 mg daily for 10 days
DL2 (n = 9): venetoclax 600 mg daily for 10 days
DL3 (n = 6): venetoclax 800 mg daily for 10 days
One patient experienced a dose‐limiting toxicity (grade 4 thrombocytopenia) at DL3, thereby defining the MTD. The next cohort of patients received a modified dosing schedule:
DL2B (n = 12): venetoclax 600 mg daily for 5 days
No patients in the DL2B cohort experienced dose‐limiting toxicities. This confirmed the DL2B dosing schedule as the optimal treatment schedule for venetoclax plus DA‐EPOCH‐R in future trials. Additional adverse events (AEs) in the overall study population included febrile neutropenia in 19 patients (63%) and serious gastrointestinal AEs in 8 patients (27%). One patient discontinued treatment due to serious gastrointestinal AEs.
The combination of venetoclax plus DA‐EPOCH‐R showed promising efficacy, with an overall response rate of 97% and complete response (CR) rate of 90%. After a median follow‐up of 13.5 months, 24 of 27 responding patients remained in CR.
Building on these results, the randomized phase II/III ALLIANCE 051701 will evaluate the addition of venetoclax to DA‐EPOCH‐R or R‐CHOP in patients with MYC/BCL2 double‐hit or double‐expressor lymphoma, respectively.
这是2020年ASCO年会上报告的一项I期研究的结果,30例侵袭性B细胞淋巴瘤患者,其中一半是双重打击,用维奈托克联合DA-EPOCH-R方案,总有效率达到97%,完全缓解率达到90%,现在已经开始进行II/III期临床试验了。虽然证据不充分,但是对于双重打击并且对化疗应答不理想的患者,加上维奈托克大概是目前已知的希望最大的手段。后面可能需要做CAR-T,但是CAR-T成功的前提条件是疾病至少能保持稳定,如果持续进展,要么等不到CAR-T要么CAR-T的效果也不理想。 |
|