Venetoclax and Homoharringtonine‐Based Therapy Exhibited a Striking Response in Refractory/Relapsed Early T‐Cell Precursor Acute Lymphoblastic Leukemia
Early T-cell precursor acute lymphoblastic leukemia (ETP-ALL) is an aggressive subtype of T-ALL. Once refractory or relapsed, it is associated with a poor prognosis, with a complete remission (CR) rate of 36%-46% following re-induction therapy. Previously, we reported a synergistic effect of venetoclax (VEN) and homoharringtonine (HHT) in ETP-ALL, which potentially elicits notable clinical responses. Herein, we investigated the efficacy and safety of the V-HAG regimen (VEN, HHT, cytarabine, and granulocyte colony-stimulating factor [G-CSF]) in patients with refractory/relapsed ETP-ALL through a prospective, multicenter, single-arm, open-label, phase 2 clinical trial. A total of 18 patients were enrolled, and 100% of these patients achieved CR or CR with incomplete hematological recovery (CRi) after 1 cycle of the V-HAG regimen as re-induction therapy. As a follow-up, both the relapse rate and mortality rate were 33.3%. The 1-year overall survival and relapse-free survival were 76.7% (95% confidence interval [CI]: 53.2%-100.0%) and 55.7% (95% CI: 28.8%-82.6%), respectively. The most common grade 3-4 adverse events were neutropenia (100%), anemia (88.9%), and thrombocytopenia (100%). Notably, the VEN- and HHT-based therapy, V-HAG regimen, exhibits an extremely high efficacy in the treatment of patients with refractory/relapsed ETP-ALL with good tolerance, and it provides a promising therapeutic strategy for improving their outcomes.
Authors
- Jie Jin (ORCID: https://orcid.org/0000-0002-8166-9915)
- Liping Mao
- Yinjun Lou (ORCID: https://orcid.org/0000-0003-4495-2460)
- Wenjuan Yu (ORCID: https://orcid.org/0000-0002-5439-141X)
- Qifa Liu (ORCID: https://orcid.org/0000-0003-4015-3952)
- Jian Hou (ORCID: https://orcid.org/0000-0001-8759-8081)
- Shaoyuan Wang (ORCID: https://orcid.org/0000-0001-7428-8682)
- Hongsheng Zhou (ORCID: https://orcid.org/0000-0002-4888-7021)
- Zhenfang Liu (ORCID: https://orcid.org/0000-0002-6499-6607)
- Tingbo Liu (ORCID: https://orcid.org/0000-0002-9296-6763)
- Xingnong Ye (ORCID: https://orcid.org/0000-0002-2657-6716)
- Xiang Zhang (ORCID: https://orcid.org/0000-0002-7543-8352)
- Na Zhang (ORCID: https://orcid.org/0000-0002-9097-9587)
- Meihong Luo (ORCID: https://orcid.org/0000-0002-7130-8411)
- Ying Lu (ORCID: https://orcid.org/0000-0003-2960-3131)
- Aiping Zhang (ORCID: https://orcid.org/0009-0000-9969-9437)
- Xiuzhen Tong (ORCID: https://orcid.org/0000-0002-7601-2812)
- Juying Wei
- Lijing Shen
- Qing-Xian Bai
- Hongyan Tong
Institutions
- Fujian Medical University (CN)
- Sun Yat-sen University (CN)
- Renji Hospital (CN)
- Shanghai University of Traditional Chinese Medicine (CN)
- First Affiliated Hospital of GuangXi Medical University (CN)
- The First Affiliated Hospital, Sun Yat-sen University (CN)
- Shanghai Traditional Chinese Medicine Hospital (CN)
- Ningbo University Affiliated Hospital (CN)
- Xijing Hospital (CN)
- Union Hospital (CN)
- First Affiliated Hospital Zhejiang University (CN)
- Southern Medical University (CN)
- Air Force Medical University (CN)
Publication Details
- Journal
- MedComm
- Published
- 2025-12-01
- DOI
- https://doi.org/10.1002/mco2.70549
- Primary Topic
- Acute Lymphoblastic Leukemia research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- National Natural Science Foundation of China
- National Key Research and Development Program of China