Condition: Acute Lymphoblastic Leukemia · Immunotherapy · Blinatumomab · Sponsor: The First Affiliated Hospital of Soochow University
This trial is a non-blinded, single-center, open-label, single-arm clinical study to evaluate a full-course immunotherapy regimen in patients with B-cell acute lymphoblastic leukemia (B-ALL). The study population includes newly diagnosed patients who are unfit for or decline intensive chemotherapy, as well as patients with relapsed/refractory disease or with measurable residual disease (MRD) positivity following prior chemotherapy. The trial aims to explore the efficacy and safety of sequential therapy with a CD19-directed CD3 T-cell engager and inotuzumab ozogamicin. The primary endpoint is overall survival (OS), while secondary endpoints include complete remission rate (CRR)、Objective Response Rate (ORR)、Event-free survival (EFS)、Relapse-free survival (RFS)、Cumulative incidence of relapse (CIR)、Non-relapse mortality (NRM) and safety.
This description comes directly from the study's public registry record.
Sheng-Li Xue, M.D. · 008651267781139 · slxue@suda.edu.cn
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| The First Affiliated Hospital of Soochow University | Suzhou, Jiangsu, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06985485