tisagenlecleucel 治疗 B 细胞 ALL 患者后感染的真实世界结局：一项 CIBMTR 分析

Tisagenlecleucel (tisa-cel) is a CD19-directed chimeric antigen receptor T-cell therapy for relapsed/refractory precursor B-cell acute lymphoblastic leukemia (R/R B-ALL).

We report infectious complications for 100 days (D100) following tisa-cel therapy in 471 pediatric and young adults (median age 13. 8 years) with R/R B-ALL reported from September 2017 to June 2022. By D100, 137 (29%) patients had an infectious event, with an infection density of 0. 542 per 100 person-days at risk. D100 cumulative incidences of bacterial, viral, and fungal infections were 14. 1%, 11. 6%, and 1. 3%, corresponding to infection density scores of 0. 296, 0. 213, and 0. 033 per 100 person-days at risk, respectively. In a multivariable analysis, receipt of ≥3 lines of therapy before tisa-cel (hazard ratio [HR], 1. 86; 95% confidence interval [CI], 1. 13-3. 08; P = . 015), any-grade cytokine release syndrome (HR, 1. 78; 95% CI, 1. 17-2. 71; P = . 007), and lack of neutrophil recovery (HR, 2.

63; 95% CI, 1. 47-4. 69; P = . 001) were associated with an increased risk for any infection. Similar associations were observed for bacterial infections, with the addition of younger age as an adverse risk (<6 vs 6-15 years; HR, 2. 38; 95% CI, 1. 23-4. 61; P = . 01). Risk factors for viral infections included increasing age (1-year increase; HR, 1. 05; 95% CI, 1. 01-1. 09; P = .

016), prior history of any infection (HR, 2. 76, 95% CI, 1. 40-5. 46; P = . 004), and prior hematopoietic cell transplant (HR, 2. 10; 95% CI, 1. 18-3. 71; P = . 011). D100 infection-related mortality (IRM) rate was low at 0. 2% (95% CI, 0. 0-0. 8). In this multicenter real-world study, we observed a high incidence of infectious complications but a low IRM following tisa-cel for R/R B-ALL.