Flumatinib Versus Imatinib Combined With Chemotherapy for de Novo Ph+ ALL
Status:
Recruiting
Trial end date:
2025-10-30
Target enrollment:
Participant gender:
Summary
Compared with patients with philadelphia chromosome-negative Acute Lymphoblastic Leukemia
(Ph- ALL), patients with Ph-positive (Ph+) ALL exhibit a comparatively poor prognosis.
Fortunately, significant improvements have been found in response rates, disease-free
survival (DFS), and overall survival (OS) for patients with Ph+ ALL with the introduction of
tyrosine kinase inhibitor (TKI) therapy to treatment regimens. Based on improvements in
efficacy and tolerability, next-generation TKIs have been widely used in first-line treatment
for chronic myeloid leukemia (CML). Flumatinib, a TKI with more potent binding affinity for
BCR-ABL1 tyrosine kinase than imatinib, demonstrated higher rates of responses, faster and
deeper responses in FESTnd trial, which suggested that flumatinib might show improved
clinical efficacy for treating Ph+ ALL compared with imatinib. The investigators therefore
hypothesized that the addition of flumatinib to combinatorial chemotherapy regimen would
demonstrate greater efficacy compared with the prior use of imatinib in treating Ph+ ALL.
This study explored the safety and efficacy of flumatinib versus imatinib when combined with
multi-agent chemotherapy in patients with newly diagnosed Ph+ ALL.