A prospective clinical trial of GVHD prophylaxis with posttransplant cyclophosphamide and abatacept.

Patients with hematologic malignancies undergoing an allogeneic transplant from an 8/8 matched related or unrelated donor were randomized 1:1 to tacrolimus and methotrexate (standard-of-care arm [SOC]) or PTCy on days +3 and +4, followed by Aba on an extended schedule: days +5, +14, and +28, and every 4 weeks up to day +168 (PTCy+Aba).

接受来自8/8相合的亲属或无关供者的异基因移植的血液恶性肿瘤患者，按照1:1的比例随机分配到他克莫司和甲氨蝶呤（标准治疗组[SOC]）或在移植后第+3天和第+4天使用PTCy，随后在第+5天、+14天和+28天以及每4周一次直至第+168天使用Aba（PTCy+Aba）。

All patients received peripherally collected stem cells.

所有患者接受了外周采集的干细胞。

The primary end point was moderate and severe chronic GVHD at 1 year.

主要终点是1年时的中度和重度慢性移植物抗宿主病（GVHD）。

Following US Food and Drug Administration approval of Aba for GVHD prophylaxis leading to change in institutional SOC, the trial was amended to enroll only on the PTCy+Aba arm.

在阿巴被美国食品药品监督管理局批准用于GVHD预防并导致机构标准治疗方案改变后，试验被修改为仅在PTCy+Aba组进行招募。

A total of 25 patients enrolled on PTCy+Aba, and 15 on SOC.

共有25名患者在PTCy+Aba组注册，15名在标准治疗方案组注册。

The trial met its primary end point: Kaplan-Meier estimates of moderate and severe chronic GVHD were 0% on the PTCy+Aba and 65.8% on the SOC arm (P < .0001).

该试验达到了其主要终点：Kaplan-Meier估计中度和重度慢性GVHD的发生率在PTCy+Aba组为0%，而在SOC组为65.8%（P < .0001）。

GVHD-free, relapse-free survival (GRFS) was 62.5% on PTCy+Aba and 24.1% on SOC (P = .010).

无GVHD和无复发生存（GRFS）在PTCy+Aba组为62.5%，而在SOC组为24.1%（P = .010）。

There were no treatment-related deaths on PTCy+Aba and 2 on SOC.

在PTCy+Aba治疗组中没有与治疗相关的死亡病例，而在SOC治疗组中有2例。

Overall survival(PTCy+Aba, 92%; SOC, 80%; P = .28), disease-free survival (PCTy+Aba, 68%; SOC, 92.9%; P = .105), and infection rates at 1 year were similar.

总生存率（PTCy+Aba组为92%，SOC组为80%；P=0.28），无病生存率（PTCy+Aba组为68%，SOC组为92.9%；P=0.105），以及1年内的感染率相似。

Grade 3/4 acute GVHD rate was 4.2% on PTCy+Aba and 21.4% on SOC (P = .092).

在接受 PTCy+Aba 组中，3/4级急性移植物抗宿主病（GVHD）的发生率为4.2%，而在标准治疗（SOC）组中为21.4%（P = .092）。

PTCy+Aba preserved regulatory T-cell proliferation and increased CD16+CD56dim cytotoxic natural killer cells.

PTCy+Aba 维持了调节性T细胞的增殖，并增加了CD16+CD56dim细胞毒性自然杀伤细胞。

In conclusion, PTCy+Aba is well tolerated and associated with reduced chronic GVHD and improved GRFS.

总之，PTCy+Aba耐受性良好，与减少的慢性移植物抗宿主病和改善的GRFS相关。

This trial was registered at www.ClinicalTrials.gov as #NCT03680092.

这项试验已在www.ClinicalTrials.gov上注册，注册号为#NCT03680092。