Leipzig Medical Center, Clinic for Hematology and Cell Therapy, University Clinic Leipzig, Leipzig, Germany.
Leipzig Medical Center, Pharmacy, University Clinic Leipzig, Leipzig, Germany.
Transfusion. 2022 Jan;62(1):157-164. doi: 10.1111/trf.16761. Epub 2021 Dec 10.
Pegfilgrastim is a covalently bound conjugate of filgrastim and mono-methoxypolyethylene glycol with a longer half-life.
We report on phase II prospective monocentric trial examining the feasibility of stem cell mobilization with 12 mg single dose pegfilgrastim in related donors. The objectives were to determine the optimal collection day, defined as CD34+ concentration in peripheral blood (PB) >50 cells/μl, the number of donors collected with single leukapheresis, and the peak level of pegfilgrastim in donor-serum. Furthermore, the cell composition of grafts was assessed and compared to published data.
The results included about 28 matched related donors. The median pegfilgrastim serum level remained >200 ng/mL for 48 hours before declining, with the maximal measured concentration of 259.49 ng/ml 24 h after application. The median white blood cell count and CD34 count in PB peaked on day four with 52.6 (range 22.8-85.0) Gpt/l and 66.25 (range 22.9-136.6) cells/μl, respectively. A CD34+ count >50 cells/μl on day four was detected in 75% of donors. 79% of the donors underwent a single collection. Conventional filgrastim was administered additionally in two donors, due to insufficient CD 34+ concentration in PB. 89% of donors showed CD34+ yields ≥4 (median 6.5, range 4.6-14.5) × 10/kg body weight of the recipient. All grafts were administered without rejections.
The results of this trial showed that stem cell mobilization with pegfilgrastim is a feasible, and attractive option. This is the first trial presenting the kinetics of pegfilgrastim serum levels in healthy donors.
培非格司亭是粒细胞集落刺激因子与单甲氧基聚乙二醇的共价结合物，具有更长的半衰期。
我们报告了一项 II 期前瞻性单中心试验，该试验检查了在相关供体中使用 12mg 单剂量培非格司亭进行干细胞动员的可行性。目的是确定最佳采集日，定义为外周血（PB）中 CD34+浓度>50 个细胞/μl，单次白细胞分离采集的供体数量，以及供体血清中培非格司亭的峰值水平。此外，还评估了移植物的细胞成分，并与已发表的数据进行了比较。
该结果包括约 28 名匹配的相关供体。培非格司亭血清水平中位数在下降前持续>200ng/mL 48 小时，应用后 24 小时的最大测量浓度为 259.49ng/ml。外周血中白细胞计数和 CD34 计数的中位数峰值分别出现在第 4 天，为 52.6（范围 22.8-85.0）Gpt/l 和 66.25（范围 22.9-136.6）细胞/μl。第 4 天 75%的供体 CD34+计数>50 个细胞/μl。79%的供体进行了单次采集。由于 PB 中 CD34+浓度不足，另外两名供体额外给予了常规粒细胞集落刺激因子。89%的供体显示 CD34+产量≥4（中位数 6.5，范围 4.6-14.5）×受者体重的 10/kg。所有移植物均无排斥反应。
该试验结果表明，培非格司亭干细胞动员是一种可行且有吸引力的选择。这是首次在健康供体中报告培非格司亭血清水平动力学的试验。
