Fixed-dose inotuzumab ozogamicin (INO) combined with Vincristine and Prednisone (VP) regimen as induction therapy for newly diagnosed B-cell acute lymphocytic leukemia (B-ALL): a multi-center, open-label, single-arm, prospective clinical study

Adult B-ALL exhibits significant heterogeneity and poor prognosis compared with the pediatric population. While the complete remission (CR) rate of traditional induction chemotherapy is 70%–90% for newly diagnosed patients [ 1 ], only 30–50% of patients attain long-term disease-free survival (DFS) exceeding 5-years [ 2 ]. For the Philadelphia chromosome-positive (ph+) patients, the addition of tyrosine kinase inhibitors (TKIs) significantly improved the CR rates [ 3 ]. In addition, achieving measurable residual disease (MRD) negativity (<10 −4 leukemic blasts), particularly early MRD negativity, is a critical determinant for long-term survival and reduces relapse [ 4 ]. Despite improvements in CR rates with traditional therapy, approximately half of them are still detected MRD positive [ 4 ]. Persistent MRD positivity is considered an independent adverse prognosis factor [ 5 ], whereas early achievement of MRD negativity in CR was associated with sustained remission [ 6 ].