Optimal frontline use of active agents in T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL) is prudent to improve outcomes. We report the long-term follow-up of the phase 2 trial of HyperCVAD with nelarabine and pegylated asparaginase (Original cohort). In the latest protocol iteration venetoclax was added to the induction/consolidation regimen (Venetoclax cohort). Eligible patients were adults with untreated T-ALL/LBL or after minimal therapy and with adequate organ function. Primary endpoint of this analysis was improvement in 2-year progression free survival (PFS) and overall survival (OS) with venetoclax. From Aug 2007 to Dec 2024, 145 patients, at a median age of 35.4 years, were treated; 46 (33.8%) were in the venetoclax cohort. At median follow-up (mFU) of 62.4 months, 5-year PFS, duration of response (DOR), and OS were 63.7%, 72.0% and 66.2% respectively. In the venetoclax cohort (mFU 24.4 months) 2-year PFS (87.9% versus 64.1%, p = 0.03) and 2-year DOR (93.6% versus 69.2%, p = 0.005) were superior to the original cohort (mFU 89.4 months) and 2-year OS appeared better (87.8% versus 73.9%, p = 0.16). Febrile neutropenia was the most common serious adverse event, seen in 60% patients. The addition of venetoclax to HyperCVAD-nelarabine-pegylated asparaginase was tolerable and led to improvement in DOR and PFS.

在 T 细胞急性淋巴细胞白血病/淋巴瘤 （T-ALL/LBL） 中最佳使用活性药物对于改善结局是谨慎的做法。我们报告了 HyperCVAD 使用奈拉滨和聚乙二醇化天冬酰胺酶的 2 期试验的长期随访（原始队列）。在最新的方案迭代中，venetoclax 被添加到诱导/巩固方案 （Venetoclax 队列） 中。符合条件的患者是未经治疗的 T-ALL/LBL 或接受最低限度治疗且器官功能足够的成人。该分析的主要终点是维奈托克组 2 年无进展生存期 （PFS） 和总生存期 （OS） 的改善。从 2007 年 8 月到 2024 年 12 月，接受了 145 名患者治疗，中位年龄为 35.4 岁;46 例 （33.8%） 属于维奈托克队列。中位随访 （mFU） 为 62.4 个月时，5 年 PFS 、缓解持续时间 （DOR） 和 OS 分别为 63.7% 、 72.0% 和 66.2%。在维奈托克队列 （mFU 24.4 个月） 中，2 年 PFS （87.9% 对 64.1%，p = 0.03） 和 2 年 DOR （93.6% 对 69.2%，p = 0.005） 优于原始队列 （mFU 89.4 个月），2 年 OS 似乎更好 （87.8% 对 73.9%，p = 0.16）。中性粒细胞减少性发热是最常见的严重不良事件，见于 60% 的患者。在 HyperCVAD-奈拉拉宾-聚乙二醇化天冬酰胺酶中添加维奈托克是可耐受的，并导致 DOR 和 PFS 的改善。