[Translation] A Phase II, Multicenter, Open-label, Dose-Ranging Study of Sepantronium Bromide in Patients with Relapsed/Refractory c-Myc-Rearranged High-Grade B-Cell Lymphoma (HGBCL)
主要目的:
确定SepB治疗c-Myc重排的复发性/难治性HGBCL的安全性和耐受性以及推荐II期剂量(RP2D)。
次要目的:
通过客观缓解率(ORR)、缓解持续时间(DoR)、临床获益率、总生存期和无进展生存期评价SepB的临床活性。
探索性目的:
1、确定SepB的暴露量及其与临床结局的相关性。
2、评估生物标记物与SepB治疗后疗效之间的相关性。
3、评估细胞遗传学数据与SepB治疗后疗效之间的相关性。
[Translation] Primary objective:
To determine the safety and tolerability of SepB in the treatment of relapsed/refractory HGBCL with c-Myc rearrangement and the recommended phase II dose (RP2D).
Secondary objectives:
To evaluate the clinical activity of SepB by objective response rate (ORR), duration of response (DoR), clinical benefit rate, overall survival and progression-free survival.
Exploratory objectives:
1. Determine the exposure of SepB and its correlation with clinical outcomes.
2. Evaluate the correlation between biomarkers and the efficacy of SepB treatment.
3. Evaluate the correlation between cytogenetic data and the efficacy of SepB treatment.