[Translation] A Phase IB/III study evaluating TAZEMETOSTAT or placebo in combination with lenalidomide + rituximab in subjects with relapsed/refractory follicular lymphoma, double-blind, randomized, active-controlled, phase 3 , Biomarker adaptability research
主要目的:在已完成至少1次既往全身化疗、免疫疗法或化学免疫疗法的R/R FL受试者中评价和比较研究者评估的tazemetostat+R2与安慰剂+R2的无进展生存期(PFS)。 次要目的:由盲态独立审查委员会(IRC)评价和比较PFS;评价和比较客观缓解率(ORR)、缓解持续时间(DOR)、完全缓解持续时间(DOCR)、疾病控制率(DCR)、通过EuroQOL 5维5级(EQ-5D-5L)工具和癌症治疗-淋巴瘤功能评估(FACT-Lym)测量的健康相关生活质量、总生存期(OS)、安全性和耐受性;评估群体药代动力学(PK)参数,包括tazemetostat与R2联合用药时的暴露-反应关系。 探索性目的:评估在治疗过程中可能出现的zeste基因增强子同源物2(EZH2)的基因变化。
[Translation] Primary objective: To evaluate and compare investigator-assessed progression-free survival (PFS) of tazemetostat+R2 versus placebo+R2 in R/R FL subjects who have completed at least 1 prior systemic chemotherapy, immunotherapy, or chemoimmunotherapy. ). Secondary objectives: Evaluation and comparison of PFS by blinded independent review committee (IRC); evaluation and comparison of objective response rate (ORR), duration of response (DOR), duration of complete response (DOCR), disease control rate (DCR), Health-related quality of life, overall survival (OS), safety, and tolerability as measured by the EuroQOL 5-Dimensional Level 5 (EQ-5D-5L) tool and the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym); population assessed Pharmacokinetic (PK) parameters, including the exposure-response relationship of tazemetostat in combination with R2. Exploratory purpose: To assess genetic changes in enhancer homolog 2 (EZH2) of the zeste gene that may occur during treatment.