一个多中心研究的移植后低剂量 inotuzumab ozogamicin 预防急性淋巴细胞白血病复发
Leland L Metheny1,2, Ronald Sobecks2,3, Christina Cho4,5
1Hematology and Cell Therapy Division, Seidman Cancer Center, University Hospitals, Cleveland, OH.
Blood advances
|January 3, 2024
概括
在急性淋巴细胞白血病 (ALL) 的全源造血干细胞移植 (allo-HCT) 后,低剂量的 inotuzumab ozogamicin (INO) 是安全有效的. 这种治疗证明了高风险ALL患者的良好的安全性和高1年无进展生存率.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 在急性淋巴细胞白血病 (ALL) 的全源造血干细胞移植 (allo-HCT) 之后,复发仍然是一个重大挑战.
- 伊诺图祖马布臭加米辛 (INO) 是一种抗CD22抗体-药物联合体,对ALL具有活性,但其在HCT后的使用需要进行安全性和可行性评估.
研究的目的:
- 为了确定最大耐受剂量 (MTD) 和低剂量INO在alo-HCT后给CD22+ALL患者的安全性.
- 在这个患者群体中评估1年无进展生存期 (PFS).
主要方法:
- 一个INO的第1阶段,3+3"剂量升级研究,对年龄在16-75岁的患者进行,在CD22+ALL完全缓解 (CR) 后40-100天,复发风险高.
- 在28天周期的第1天,INO在0.3,0.4,0.5和0.6mg/m2的剂量水平上被施用.
- 关键的安全终点包括鼻状阻塞综合征 (SOS) 和MTD的确定;疗效终点是1年的PFS.
主要成果:
- 18名患者被录取,平均年龄为44岁; 72%接受了强度降低的调节.
- 确定INO的MTD为0.6 mg/m2;最常见的毒性是血栓细胞减小.
- 没有观察到SOS病例. 一年无复发死亡率为5.6%. 一年PFS和整体生存率分别为89%和94%.
结论:
- 低剂量INO显示出有利的安全性概况,并且在alo-HCT后高风险ALL患者中可行.
- 观察到的高1年PFS率表明在这种情况下可能有治疗益处.
- 需要在更大的试验中进行进一步的调查,以证实这些有希望的发现.
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