Reduced-dose chemotherapy followed by blinatumomab for newly diagnosed philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia: a propensity-matched comparison with hyper-CVAD.

IF 2.8 4区医学 Q3 ENDOCRINOLOGY & METABOLISM Discover. Oncology Pub Date : 2025-02-21 DOI:10.1007/s12672-025-01968-8

Jing Lu, Yu Zhu, Huiying Qiu, Ying Wang, Xin Zhou, Haiping Dai, Xuzhang Lu, Bin Gu, Ming Hong, Miao Miao, Ruinan Lu, Jun Wang, Qian Wu, Mengxing Xue, Yun Wang, Ailing Deng, Yaoyao Shen, Yin Liu, Xueqing Dou, Yutian Lei, Xiaofei Yang, Suning Chen

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Abstract

Background: Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (Ph-negative BCP-ALL) accounts for a significant portion of adult cases. Blinatumomab, a bispecific T-cell engager, has shown efficacy in relapsed or refractory BCP-ALL, but its role in induction therapy with reduced-dose chemotherapy is being explored.

Methods: In this retrospective study, 35 newly diagnosed Ph-negative BCP-ALL patients received reduced-dose chemotherapy followed by two weeks of blinatumomab (RDC-Blinatumomab-2W) as part of our previous clinical trial. These patients were compared with a propensity score-matched historical control group of 35 patients treated with the hyper-CVAD regimen. The primary endpoint was composite complete remission (CRc); secondary endpoints included minimal residual disease (MRD) negativity, adverse events, and survival outcomes.

Results: After matching, both groups had 17 patients (49%) with poor-risk genetic aberrations. The RDC-Blinatumomab-2W group achieved higher CRc rates compared to controls (94% vs. 63%, p = 0.0074) and greater MRD negativity (86% vs. 43%, p = 0.0015). They experienced fewer Grade 3-4 thrombocytopenia cases (62% vs. 89%, p = 0.012), fewer serious infections (23% vs. 54%, p = 0.019), and higher 1-year overall survival rates (97.1% vs. 58.9%, p < 0.001). The 1-year progression-free survival was also superior in the RDC-Blinatumomab-2W group (82.2% vs. 44.6%, p = 0.002).

Conclusion: Reduced-dose chemotherapy followed by blinatumomab improves remission rates, MRD negativity, and survival while reducing adverse events in newly diagnosed Ph-negative BCP-ALL patients compared to hyper-CVAD. This regimen offers a safer and more effective induction therapy option, warranting further investigation in larger trials.

Clinicaltrials:

Gov identifier: NCT05557110; registered on September 8, 2022.

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