[Translation] A Phase Ib/II dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PD5K3 combined with chemotherapy in patients with acute lymphoblastic leukemia or lymphoblastic lymphoma
主要目的:
剂量递增阶段(Ib期):评价PD5K3联合化疗治疗ALL/LBL的安全性、耐受性,确定联合化疗的PD5K3的最大耐受剂量(MTD)。
剂量扩展阶段(II期):比较PD5K3联合化疗与培门冬酶联合化疗治疗ALL/LBL的PK/PD特征,并选择后期推荐剂量。
[Translation] Primary Objectives:
Dose-Escalation Phase (Phase Ib): Evaluate the safety and tolerability of PD5K3 combined with chemotherapy in the treatment of ALL/LBL and determine the maximum tolerated dose (MTD) of PD5K3 in combination with chemotherapy.
Dose-Expansion Phase (Phase II): Compare the PK/PD profiles of PD5K3 combined with chemotherapy and pegaspargase combined with chemotherapy in the treatment of ALL/LBL and select a recommended dose for the future.