Faculty Collaboration Database

Real-world outcomes of infections following tisagenlecleucel in patients with B-cell ALL: a CIBMTR analysis. Blood Adv 2025 Nov 11;9(21):5489-5500

Date

07/30/2025

Pubmed ID

40737539

Pubmed Central ID

PMC12607035

DOI

10.1182/bloodadvances.2025016149

Scopus ID

2-s2.0-105022753658 (requires institutional sign-in at Scopus site)   1 Citation

Abstract

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.

Author List

Rangarajan HG, Satwani P, Herr MM, Chen M, Martens MJ, Wudhikarn K, John S, Fabrizio VA, Hsieh EM, Kelkar AH, Doherty E, Marks DI, Ringden O, Friend B, Kelly MS, Farhadfar N, Prestidge T, Hossain NM, Liu H, Hashmi S, Modi D, Winestone LE, El Boghdadly Z, Murthy HS, Perales MA, Chemaly RF, Dandoy CE, Hill JA, Huppler A, Riches M, Auletta JJ

Authors

Anna Huppler MD Associate Professor in the Pediatrics department at Medical College of Wisconsin
Michael Martens PhD Assistant Professor in the Data Science Institute department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Adolescent
Adult
Child
Child, Preschool
Female
Humans
Immunotherapy, Adoptive
Male
Precursor B-Cell Lymphoblastic Leukemia-Lymphoma
Receptors, Antigen, T-Cell
Treatment Outcome
Young Adult