Fixed-duration VenO vs FCR/BR in fit patients with untreated CLL: primary analysis of the phase 3 CRISTALLO trial.

Previously untreated patients with a cumulative illness rating scale score ≤6 and creatinine clearance ≥70 mL/min without del(17p)/TP53 mutations were randomized 1:1 to VenO or FCR/BR.

之前未经治疗的患者，累积疾病评分≤6，肌酐清除率≥70 mL/min，且没有del(17p)/TP53突变，被随机分为1:1的VenO或FCR/BR组。

The primary end point was uMRD (<10-4) in peripheral blood (PB) using next-generation sequencing at month 15.

主要终点是在第15个月使用下一代测序技术在在外周血（PB）中检测到的微小残留病灶（uMRD，<10^-4）。

Key secondary end points included uMRD (<10-4) in PB and bone marrow (BM) at end of treatment (EOT) and progression-free survival(PFS). uMRD at deeper cutoffs were explored.

关键次要终点包括治疗结束时（EOT）在外周血（PB）和骨髓（BM）中检测到的微小残留病灶（uMRD，<10^-4）以及无进展生存期（PFS）。还探索了更深层次的uMRD截断值。

At data cutoff (19 March 2024), 80 patients received VenO, and 86 received FCR/BR.

截至数据截止日期（2024年3月19日），共有80名患者接受了VenO治疗，86名患者接受了FCR/BR治疗。

Baseline characteristics were generally balanced across arms.

两组患者的基线特征总体上保持平衡。

The primary end point was met: 81.3% (VenO) and 54.7% (FCR/BR) achieved uMRD (<10-4) in PB at month 15 (P = .0004). uMRD (<10-4) in PB and BM at EOT was also higher with VenO vs FCR/BR.

主要终点达成：在第15个月时，81.3%（VenO组）和54.7%（FCR/BR组）的患者在外周血（PB）中实现了未检测到最小残留病灶（uMRD，<10^-4）（P = .0004）。在治疗结束时（EOT），VenO组在外周血和骨髓（BM）中实现uMRD（<10^-4）的比例也高于FCR/BR组。

Short follow-up precluded evaluation of PFS at the first planned interim analysis; however, fewer patients progressed/died with VenO vs FCR/BR (7 vs 13).

由于随访时间较短，首次计划的中期分析中无法评估无进展生存期（PFS）；然而，与FCR/BR组相比，接受VenO治疗的患者中进展或死亡的患者较少（7例对13例）。

At month 15, 65.0% (VenO) and 25.6% (FCR/BR) achieved uMRD (<10-6) in PB.

在第15个月时，65.0% (VenO) 和 25.6% (FCR/BR) 在外周血中实现了uMRD (<10^-6)。

The overall safety profile was consistent with the known safety profile of each drug.

总体安全性特征与每种药物已知的安全性特征一致。

No patient in the VenO arm was deemed high risk for tumor lysis syndrome (TLS) after obinutuzumab debulking; no clinical TLS occurred.

在 obinutuzumab 减瘤治疗后，VenO组中没有患者被认为是肿瘤溶解综合征（TLS）的高风险；未发生临床TLS。

These results confirm and extend the findings from the GAIA-CLL13 trial, validating increased depth of response with VenO vs chemoimmunotherapies.

这些结果确认并扩展了GAIA-CLL13试验的发现，验证了与化疗免疫治疗相比，VenO可增加反应深度。

This trial was registered at www.clinicaltrials.gov as NCT04285567.

该试验已在www.clinicaltrials.gov上注册，注册号为NCT04285567。