Ai H, Liang T T, Wang Q, Wu H F, Yin Q S
Department of Hematology, the Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou 450008, China.
Zhonghua Xue Ye Xue Za Zhi. 2025 Jul 14;46(7):655-659. doi: 10.3760/cma.j.cn121090-20241202-00521.
This study sought to evaluate the efficacy and safety of venetoclax (Ven) in combination with tyrosine kinase inhibitors (TKI) and reduced-dose chemotherapy for the treatment of patients with minimal residual disease (MRD) -positive and relapsed/refractory (R/R) Ph-positive acute lymphoblastic leukemia (Ph(+) ALL). A retrospective analysis was conducted on the clinical data of 13 patients with MRD-positive and relapsed Ph(+) ALL admitted between July 2015 and February 2024 at the Affiliated Cancer Hospital of Zhengzhou University. The cohort included seven males and six females, with a median age of 50 years (range: 37-71 years). Reinduction therapy consisted of Ven and TKI administration combined with reduced-dose chemotherapy. Among the 13 patients, 10 were MRD-positive, and three had R/R disease. Of the MRD-positive group, nine (90%) achieved complete molecular response (CMR), with a median time to response of 47 days (range: 30-80) ; one patient did not respond. Among the three patients who had R/R, two (66.6%) achieved complete remission, while one patient was nonresponsive. The median overall survival (OS) and relapse-free survival (RFS) time for the entire cohort were 21.5 months and 7 months, respectively. In patients who achieved CMR, the median OS and RFS time were 35 months and 34 months, respectively. Grade ≥3 hematologic adverse events occurred in five patients (38.4%) ; however, hematopoietic function recovered in all cases, and no grade ≥3 infections or organ-related adverse reactions were observed. These findings suggest that Ven combined with TKI and reduced-dose chemotherapy may be an effective and tolerable therapeutic strategy for MRD-positive and R/R Ph(+) ALL, particularly in significantly improving MRD clearance rates.
本研究旨在评估维奈克拉（Ven）联合酪氨酸激酶抑制剂（TKI）及小剂量化疗治疗微小残留病（MRD）阳性且复发/难治性（R/R）Ph阳性急性淋巴细胞白血病（Ph(+) ALL）患者的疗效和安全性。对2015年7月至2024年2月在郑州大学附属肿瘤医院收治的13例MRD阳性且复发的Ph(+) ALL患者的临床资料进行回顾性分析。该队列包括7名男性和6名女性，中位年龄为50岁（范围：37 - 71岁）。再诱导治疗包括维奈克拉和TKI给药联合小剂量化疗。13例患者中，10例为MRD阳性，3例为R/R疾病。在MRD阳性组中，9例（90%）达到完全分子缓解（CMR），中位缓解时间为47天（范围：30 - 80天）；1例患者未缓解。在3例R/R患者中，2例（66.6%）达到完全缓解，1例患者无反应。整个队列的中位总生存期（OS）和无复发生存期（RFS）分别为21.5个月和7个月。在达到CMR的患者中，中位OS和RFS时间分别为35个月和34个月。5例患者（38.4%）发生≥3级血液学不良事件；然而，所有病例的造血功能均恢复，未观察到≥3级感染或器官相关不良反应。这些发现表明，维奈克拉联合TKI及小剂量化疗可能是MRD阳性和R/R Ph(+) ALL的一种有效且可耐受的治疗策略，尤其在显著提高MRD清除率方面。
