Venetoclax combined with homoharringtonine, cytarabine and aclacinomycin as induction therapy in newly diagnosed Chinese acute myeloid leukaemia patients: A multicentre phase II study
To evaluate the efficacy and safety of the HAAV regimen (venetoclax, aclarubicin, cytarabine, homoharringtonine) as induction therapy for newly diagnosed adult acute myeloid leukaemia (AML). This multicentre, single-arm, prospective clinical trial included 84 AML patients (aged 18-60) from eight Chinese hospitals. The HAAV regimen was administered, with venetoclax dosed at 100 mg on day 1, 200 mg on day 2 and 400 mg on days 3-8, combined with homoharringtonine, cytarabine and aclarubicin on days 3-7. The overall response rate after one cycle was 95.2% (95% confidence interval [CI] 88.3-98.7), with 92.9% achieving complete remission + incomplete count recovery (95% CI 83.6-96.6). Among responders, 89.9% (95% CI 80.2-95.8) had minimal residual disease negativity. With a median follow-up of 15.5 months, the -1-year overall survival was 77.9% (95% CI 18.3-26.1), relapse-free survival was 83.9% (95% CI 19.2-22.3) and event-free survival was 71.3% (95% CI 16.9-20.5). The HAAV regimen is highly efficacious and safe for newly diagnosed AML patients.
Authors
- Guanchen Bai
- Yingchang Mi (ORCID: https://orcid.org/0000-0002-5060-5070)
- Zeping Zhou (ORCID: https://orcid.org/0000-0002-7698-7695)
- Yinling Li
- Xinxiao Lu (ORCID: https://orcid.org/0000-0002-9811-7332)
- Linyu Yuan (ORCID: https://orcid.org/0000-0001-9299-5786)
- Kaiqi Liu (ORCID: https://orcid.org/0000-0002-1532-0301)
- Pengxiang Guo (ORCID: https://orcid.org/0000-0002-2176-3272)
- Heng Li (ORCID: https://orcid.org/0000-0002-3633-6679)
- Congcong Zhang (ORCID: https://orcid.org/0000-0001-9995-3079)
- Jilei Zhang (ORCID: https://orcid.org/0000-0002-8586-3889)
- Weihua Zhao
- Yaxian Tan (ORCID: https://orcid.org/0000-0002-1652-0487)
- Xingli Zhao (ORCID: https://orcid.org/0009-0006-1848-1318)
- Hongling Peng (ORCID: https://orcid.org/0000-0003-2770-5150)
- Xiaohui Suo
- Yunya Luo
- Zeyan Shi
- Sifeng Gao
Institutions
- Handan College (CN)
- Central South University (CN)
- Guangxi Medical University (CN)
- Chinese Academy of Medical Sciences & Peking Union Medical College (CN)
- Nankai University (CN)
- Kunming Medical University (CN)
- First Affiliated Hospital of GuangXi Medical University (CN)
- Institute of Hematology & Blood Diseases Hospital (CN)
- Taian City Central Hospital (CN)
- Second Xiangya Hospital of Central South University (CN)
- Guizhou Provincial People's Hospital (CN)
Publication Details
- Journal
- British Journal of Haematology
- Published
- 2025-10-28
- DOI
- https://doi.org/10.1111/bjh.70202
- Primary Topic
- Acute Myeloid Leukemia Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00