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已发表论文
维奈克拉联合博纳吐单抗作为新诊断的费城染色体阴性 B 细胞急性淋巴细胞白血病的一线治疗
Authors Lei Y, Zhao X , Huang H, Duan L, Xu J, Miao K, Zhao H, Qiao C, Hong M, Qian S, Fan L, Zhu Y
Received 29 July 2025
Accepted for publication 30 October 2025
Published 5 November 2025 Volume 2025:15 Pages 193—202
DOI https://doi.org/10.2147/BLCTT.S556608
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Wilson Gonsalves
Yutian Lei,1 Xiaoli Zhao,1 Huijun Huang,1 Limin Duan,1 Ji Xu,1 Kourong Miao,1 Huihui Zhao,2 Chun Qiao,1 Ming Hong,1 Sixuan Qian,1 Lei Fan,1 Yu Zhu1
1Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China; 2Department of Oncology, Nanjing second Hospital, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, People’s Republic of China
Correspondence: Yu Zhu, Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China, Email zhuyu@jsph.org.cn
Purpose: This study evaluated the efficacy and safety of a 14-day blinatumomab-venetoclax (BV) regimen as induction therapy for newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia (B-ALL), focusing on rapid remission and tolerability in unfit patients.
Patients and Methods: Thirteen patients received venetoclax (100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg from days 4 to 14) with blinatumomab (9 to 28 ug/day) for 14 days. Bone marrow assessments were performed at days 14– 21. Primary endpoints were complete remission (CR) rate, minimal residual disease (MRD) negativity by flow cytometry, and adverse events.
Results: The CR rate after one cycle of BV regimen was 92.3% (12/13), and all patients achieved MRD-negativity; 91.7% (11/12) achieved MRD clearance by day 21. Grade 1– 2 cytokine release syndrome occurred in 46.2% (6/13; 1 grade 3). Hematologic toxicity included grade 3– 4 neutropenia (92.3%) and thrombocytopenia (46.2%), with only 30.8% febrile neutropenia. All AEs resolved rapidly with supportive care, allowing therapy to continue without interruption. At median follow-up of 283 days, 1-year relapse-free survival rate and overall survival rate were 60.6% and 83.3%.
Conclusion: The 14-day BV regimen induced rapid deep remission (91.7% MRD-negative by day 21) with manageable toxicity in Ph-negative B-ALL. Synergistic T-cell activation by venetoclax may explain enhanced efficacy.
Keywords: venetoclax, blinatumomab, Ph-negative B-cell acute lymphoblastic leukemia
1Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China; 2Department of Oncology, Nanjing second Hospital, Nanjing University of Chinese Medicine, Nanjing, Jiangsu, People’s Republic of China
Correspondence: Yu Zhu, Department of Hematology, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, Jiangsu, People’s Republic of China, Email zhuyu@jsph.org.cn
Purpose: This study evaluated the efficacy and safety of a 14-day blinatumomab-venetoclax (BV) regimen as induction therapy for newly diagnosed Ph-negative B-cell acute lymphoblastic leukemia (B-ALL), focusing on rapid remission and tolerability in unfit patients.
Patients and Methods: Thirteen patients received venetoclax (100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg from days 4 to 14) with blinatumomab (9 to 28 ug/day) for 14 days. Bone marrow assessments were performed at days 14– 21. Primary endpoints were complete remission (CR) rate, minimal residual disease (MRD) negativity by flow cytometry, and adverse events.
Results: The CR rate after one cycle of BV regimen was 92.3% (12/13), and all patients achieved MRD-negativity; 91.7% (11/12) achieved MRD clearance by day 21. Grade 1– 2 cytokine release syndrome occurred in 46.2% (6/13; 1 grade 3). Hematologic toxicity included grade 3– 4 neutropenia (92.3%) and thrombocytopenia (46.2%), with only 30.8% febrile neutropenia. All AEs resolved rapidly with supportive care, allowing therapy to continue without interruption. At median follow-up of 283 days, 1-year relapse-free survival rate and overall survival rate were 60.6% and 83.3%.
Conclusion: The 14-day BV regimen induced rapid deep remission (91.7% MRD-negative by day 21) with manageable toxicity in Ph-negative B-ALL. Synergistic T-cell activation by venetoclax may explain enhanced efficacy.
Keywords: venetoclax, blinatumomab, Ph-negative B-cell acute lymphoblastic leukemia