A Phase 3 open-label randomized study to compare the efficacy and safety of rituximab plus lenalidomide versus rituximab plus chemotherapy followed by rituximab in subjects with previously untreated follicular lymphoma (NHL27)
收藏资源简介:
This dataset contains individual participant data (IPD) from the NHL27 study, a phase 3 open-label randomised trial comparing the efficacy and safety of rituximab plus lenalidomide versus rituximab plus chemotherapy followed by rituximab maintenance in patients with previously untreated follicular lymphoma. The dataset includes patient-level demographic and clinical information such as age, sex, disease stage, prognostic risk factors, and baseline laboratory values. Treatment data include allocated therapy, dosing, treatment duration, and exposure. Outcome data include response assessments, progression-free survival, overall survival, and adverse events. The study population comprises approximately 750 (globally) adult patients with previously untreated follicular lymphoma enrolled across Australasian sites. Data are collected at predefined timepoints including baseline, during induction therapy, during maintenance treatment, and at scheduled follow-up visits for disease assessment and survival outcomes. This dataset is suitable for secondary analyses including comparative effectiveness research, evaluation of treatment response and durability, safety profiling, and optimisation of first-line treatment strategies in follicular lymphoma.
本数据集包含来自NHL27研究的个体参与者数据(IPD)。该研究为一项Ⅲ期(phase 3)开放标签随机对照试验,对比了利妥昔单抗(rituximab)联合来那度胺(lenalidomide)与利妥昔单抗联合化疗后序贯利妥昔单抗维持治疗,在既往未接受治疗的滤泡淋巴瘤(follicular lymphoma)患者中的疗效与安全性。数据集涵盖患者层面的人口统计学与临床信息,包括年龄、性别、疾病分期、预后危险因素以及基线实验室检测指标。治疗相关数据包含分配治疗方案、给药剂量、治疗时长以及药物暴露情况。结局数据包含疗效评估、无进展生存期(progression-free survival)、总生存期(overall survival)以及不良事件。该研究队列共纳入全球范围内约750例既往未接受治疗的滤泡淋巴瘤成年患者,入组中心覆盖澳大拉西亚地区。数据按照预设时间节点采集,包括基线期、诱导治疗期间、维持治疗期间,以及用于疾病评估和生存结局随访的预定随访访视。本数据集适用于多项二次分析,包括比较有效性研究、治疗应答及其持久性评估、安全性特征分析以及滤泡淋巴瘤一线治疗策略的优化。



