[Translation] An open-label, multicenter, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics (PK) of belintozumab in Chinese pediatric subjects with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (R/R B-ALL)
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] Primary objective: To evaluate the efficacy of belintoumab;
Secondary objectives: To evaluate the safety and tolerability of belintoumab; To evaluate the pharmacokinetics (PK) of belintoumab; To evaluate the overall survival (OS) after belintoumab treatment; To evaluate the relapse-free survival after belintoumab treatment; To evaluate the use of alloHSCT and the 100-day mortality after alloHSCT use; To evaluate the immunogenicity of belintoumab; To evaluate minimal residual disease (MRD).