An Australasian, phase II, multicentre, randomised, dose intensification study investigating oral fludarabine, oral cyclophosphamide and i.v. rituximab (poFCivR) tolerance in previously untreated elderly (≥ 65 years old) patients with chronic lymphocytic leukaemia (CLL05)

Dataset includes: Full data of 149 patients with a poor prognosis of diffuse large b-cell lymphoma was analysed (151 eligible patients - 3 patients withdrawing consent) Safety population analyzed was 151 patients (all patients that received at least 1 dose) ECOG performance status was assessed for all 151 patients (ECOG taken pre-treatment) Objective to demonstrated effectiveness of using PET/CT scanning to determine further treatment post 4 cycles of R-CHOP-14 treatment ○ PET/CT positive patients receiving R-ICE x 3 followed by Z-BEAM/ASCT + IF-RT ○ PET/CT negative patients recevigin R_CHOP-14 x 2 Interim PET response of 143 patients (after 4 cycles of R-CHOP 14 Data of Follow Up of 143 patients went for a minimum length of 0.065 months, and a maximum length of 65.22 (as months since interim PET scan)

本数据集纳入经分析的149例弥漫大B细胞淋巴瘤（diffuse large B-cell lymphoma）预后不良患者的完整临床数据；初始入组合格患者共151例，其中3例撤回知情同意。本研究的安全性分析人群为151例（即所有接受至少1剂治疗的患者）。研究人员对全部151例患者均完成了ECOG体能状态评分（ECOG performance status），评分于抗肿瘤治疗前进行。本研究的核心目标为验证正电子发射计算机断层显像/计算机断层扫描（PET/CT）在4周期R-CHOP-14方案治疗后指导后续治疗方案选择的临床有效性：其中PET/CT显像阳性的患者将接受3周期R-ICE方案治疗，后续予以Z-BEAM方案联合自体造血干细胞移植（ASCT）及受累野放疗（IF-RT）；PET/CT显像阴性的患者则继续接受2周期R-CHOP-14方案治疗。本数据集包含143例患者在4周期R-CHOP-14治疗后的中期PET影像学应答数据，另有143例患者的随访数据纳入本数据集，随访时长最短为0.065个月，最长为65.22个月（随访时长以中期PET扫描完成后的时间计）。