一项Sepantronium Bromide治疗复发性/难治性c-Myc重排高级别B细胞淋巴瘤(HGBCL)患者的II期、多中心、开放性、剂量范围探索研究
[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] main purpose:
To determine the safety and tolerability and recommended phase II dose (RP2D) of SepB for the treatment of c-Myc-rearranged relapsed/refractory HGBCL.
Secondary purpose:
The clinical activity of SepB was evaluated by objective response rate (ORR), duration of response (DoR), clinical benefit rate, overall survival and progression-free survival.
Exploratory Purpose:
1. To determine SepB exposure and its correlation with clinical outcomes.
2. To evaluate the correlation between biomarkers and the efficacy of SepB treatment.
3. To evaluate the correlation between the cytogenetic data and the efficacy after SepB treatment.
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