ORIGINAL RESEARCH article
Front. Oncol.
Sec. Hematologic Malignancies
Efficacy and safety of flumatinib in adults with Ph-positive ALL: a prospective observational study
Provisionally accepted
- Affiliated Hospital of Hebei University, Baoding, China
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Objective: To evaluate the efficacy and safety of flumatinib, a second-generation tyrosine kinase inhibitor (TKI), combined with chemotherapy in the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), and to analyze factors influencing prognosis. Methods: This prospective, single-center, observational study included 15 newly diagnosed adult Ph+ ALL patients admitted between January 2022 and December 2024. All patients received a flumatinib-based combination chemotherapy regimen (600 mg once daily). The primary outcomes included complete remission (CR) rate, negativity rates for fusion gene and flow cytometry-based minimal residual disease (MRD), progression-free survival (PFS), overall survival (OS), and adverse events (AEs). Results: Among the 15 patients, 14 achieved hematological complete remission (93.3%). At the end of induction therapy, the fusion gene and flow-MRD negativity rates were 60.0% (9/15) and 73.3% (11/15), respectively. By 3 months of treatment, the cumulative negativity rates increased to 80.0% (12/15) and 86.7% (13/15), respectively. With a median follow-up of 26 months, the median PFS and OS were 11 months (range: 1–60) and 24 months (range: 6–60), respectively. Subgroup analysis revealed that two patients with chronic myeloid leukemia in lymphoid blast phase (CML-LBP) had extremely poor outcomes, with median PFS and OS of only 3 months and 7.5 months, respectively. The most common grade 3–4 adverse events were hematological toxicities (53.3%), followed by infections and liver function abnormalities. All AEs were manageable with supportive care, and no treatment-related deaths occurred. Conclusion: Flumatinib combined with chemotherapy induced high remission rates and deep molecular responses in newly diagnosed Ph+ ALL patients, with a favorable safety profile. However, patients with CML-LBP or high-risk Ph+ ALL had poor treatment responses and outcomes, indicating the need for more aggressive intervention strategies in this high-risk population.
Keywords: Acute Lymphoblastic Leukemia, Philadelphia Chromosome, Flumatinib, Minimal Residual Disease, treatment outcome
Received: 09 Oct 2025; Accepted: 17 Nov 2025.
Copyright: © 2025 Xu, Wang, Zhao, Guo, Zhang, Liu, Hua and Xue. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Jianmei Xu, xjm245272002@163.com
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