[Translation] A Phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy and safety of golcadomide plus R-CHOP chemotherapy versus placebo plus R-CHOP chemotherapy in subjects with previously untreated high-risk large B-cell lymphoma
主要目的:在未经治的高危大B细胞淋巴瘤受试者中评价golcadomide+R-CHOP对比安慰剂-R-CHOP的研究者评估的PFS疗效。
次要目的: 在未经治的高危大B细胞淋巴瘤受试者中:
评价golcadomide+R-CHOP对比安慰剂-R-CHOP的OS疗效、研究者评估的EFS疗效、IRAC评估的CMR疗效,以及EOT时MRD阴性的疗效。
评价golcadomide+R-CHOP对比安慰剂-R-CHOP的IRAC评估的PFS疗效、研究者评估的OR疗效、研究者评估的CMR疗效、PFS24疗效、DoR疗效、PFS2疗效、CHOP细胞毒性组分的相对剂量强度暴露;通过EORTCQLQ-C30和FACT-LymS测量,比较golcadomide+R-CHOP与安慰剂-R-CHOP的疾病症状、功能和总体HRQoL。
对比golcadomide+R-CHOP与安慰剂-R-CHOP的安全性。
对比golcadomide+R-CHOP与安慰剂-R-CHOP治疗对HCRU的影响、对总体健康状况和效用的影响。
[Translation] Primary objective: To evaluate the efficacy of golcadomide + R-CHOP vs. placebo-R-CHOP on investigator-assessed PFS in subjects with untreated high-risk large B-cell lymphoma.
Secondary objectives: In subjects with untreated high-risk large B-cell lymphoma:
To evaluate the efficacy of golcadomide + R-CHOP vs. placebo-R-CHOP on OS, investigator-assessed EFS, IRAC-assessed CMR, and MRD negativity at EOT.
To evaluate the efficacy of golcadomide + R-CHOP vs. placebo-R-CHOP on IRAC-assessed PFS, investigator-assessed OR, investigator-assessed CMR, PFS24, DoR, PFS2, and relative dose intensity exposure of CHOP cytotoxic components; to compare disease symptoms, function, and overall HRQoL between golcadomide + R-CHOP and placebo-R-CHOP as measured by EORTCQLQ-C30 and FACT-LymS.
Compare the safety of golcadomide + R-CHOP with placebo-R-CHOP.
Compare the effects of golcadomide + R-CHOP with placebo-R-CHOP on HCRU, overall health status, and utility.