TY - JOUR
T1 - Real-world outcomes of infections following tisagenlecleucel in patients with B-cell ALL
T2 - a CIBMTR analysis
AU - Rangarajan, Hemalatha G.
AU - Satwani, Prakash
AU - Herr, Megan M.
AU - Chen, Min
AU - Martens, Michael J.
AU - Wudhikarn, Kitsada
AU - John, Samuel
AU - Fabrizio, Vanessa A.
AU - Hsieh, Emily M.
AU - Kelkar, Amar H.
AU - Doherty, Erin
AU - Marks, David I.
AU - Ringden, Olle
AU - Friend, Brian
AU - Kelly, Matthew S.
AU - Farhadfar, Nosha
AU - Prestidge, Tim
AU - Hossain, Nasheed M.
AU - Liu, Hongtao
AU - Hashmi, Shahrukh
AU - Modi, Dipenkumar
AU - Winestone, Lena E.
AU - El Boghdadly, Zeinab
AU - Murthy, Hemant S.
AU - Perales, Miguel-Angel
AU - Chemaly, Roy F.
AU - Dandoy, Christopher E.
AU - Hill, Joshua A.
AU - Huppler, Anna
AU - Riches, Marcie
AU - Auletta, Jeffery J.
N1 - Publisher Copyright:
© 2025 The American Society of Hematology
PY - 2025/11/11
Y1 - 2025/11/11
N2 - 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.
AB - 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.
U2 - 10.1182/bloodadvances.2025016149
DO - 10.1182/bloodadvances.2025016149
M3 - Article (Academic Journal)
C2 - 40737539
SN - 2473-9529
VL - 9
SP - 5489
EP - 5500
JO - Blood Advances
JF - Blood Advances
IS - 21
ER -