Infections lead to substantial morbidity during the treatment of acute lymphoblastic leukemia (ALL) in which the adaptive immune system is severely affected, leading to declining serum immunoglobulin levels. We performed a trial to investigate whether intravenous immunoglobulin (IVIG) prophylaxis in pediatric patients with ALL could prevent admissions for fever. This randomized controlled trial was a subtrial of the national Dutch multicenter ALL study. Patients aged 1-19 years with medium-risk ALL were randomized into two groups receiving either IVIG prophylaxis (0.7 g/kg IVIG given every 3 weeks, starting on day 22 after diagnosis) or well-defined standard of care (control group). Between October 2012 and March 2019, 91 (51%) patients were randomly assigned to IVIG prophylaxis and 86 (49%) to the control arm. In the IVIG prophylaxis group there were 206 admissions for fever versus 271 in the control group (P=0.011). IVIG prophylaxis was not associated with bacteremia. However, there were significantly fewer admissions for fever with negative blood cultures in the IVIG prophylaxis group than in the control group (113 vs. 200, P<0.001). The difference in number of admissions for fever was observed specifically during maintenance treatment (100 vs. 166, P<0.001) resulting in fewer courses of antibiotic treatment (78 vs. 137, P<0.001) and fewer cases of chemotherapy adaptation (72 vs. 134, P<0.001). In conclusion, in pediatric patients with medium-risk ALL, IVIG prophylaxis was associated with significantly fewer admissions for fever with negative blood cultures during maintenance treatment, resulting in fewer courses of antibiotic treatment and fewer chemotherapy adaptations.

中文翻译：

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免疫球蛋白预防预防儿科急性淋巴细胞白血病因发热入院：一项多中心随机试验的结果。


感染会导致急性淋巴细胞白血病 （ALL） 治疗期间的大量并发症，其中适应性免疫系统受到严重影响，导致血清免疫球蛋白水平下降。我们进行了一项试验，以调查 ALL 儿科患者的静脉注射免疫球蛋白 （IVIG） 预防是否可以预防发热入院。这项随机对照试验是荷兰国家多中心 ALL 研究的子试验。1-19 岁的中危 ALL 患者被随机分为两组，接受 IVIG 预防治疗 （0.7 g/kg IVIG，每 3 周给药一次，从诊断后第 22 天开始）或明确的护理标准 （对照组）。在 2012 年 10 月至 2019 年 3 月期间，91 例 （51%） 患者被随机分配到 IVIG 预防组，86 例 （49%） 患者被随机分配到对照组。在 IVIG 预防组中，有 206 例因发热入院，而对照组有 271 例 （P = 0.011）。IVIG 预防与菌血症无关。然而，IVIG 预防组血培养阴性的发热入院人数显著少于对照组 （113 vs. 200，P<0.001）。特别是在维持治疗期间观察到发热入院人数的差异 （100 vs. 166，P<0.001），导致抗生素治疗疗程减少 （78 vs. 137，P<0.001） 和化疗适应病例减少 （72 vs. 134，P<0.001）。总之，在中等风险 ALL 儿科患者中，IVIG 预防与维持治疗期间血培养阴性的发热入院率显著减少相关，导致抗生素治疗疗程减少和化疗适应减少。