[Translation] A study to evaluate the efficacy, safety, and pharmacokinetics (PK) of belintuzumab in Chinese pediatric subjects with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL) ), an open-label, multi-center, Phase 2 study
主要目的:评价贝林妥欧单抗的有效性;
次要目的:评价贝林妥欧单抗的安全性和耐受性;评价贝林妥欧单抗的药代动力学(PK);评价贝林妥欧单抗治疗后的总生存期(OS);评价贝林妥欧单抗治疗后的无复发生存期;评估alloHSCT的使用和alloHSCT使用后的100天死亡率;评价贝林妥欧单抗的免疫原性;评价微小残留病(MRD)。
[Translation] Main purpose: To evaluate the effectiveness of belintuzumab;
Secondary objectives: To evaluate the safety and tolerability of belintuzumab; to evaluate the pharmacokinetics (PK) of belintuzumab; to evaluate the overall survival (OS) after belintuzumab treatment ); Evaluate relapse-free survival after belintuzumab treatment; Evaluate the use of alloHSCT and 100-day mortality after alloHSCT use; Evaluate the immunogenicity of belintuzumab; Evaluate minimal residual disease (MRD) .