Real-World Outcomes of Infections Following Tisagenlecleucel in Patients with B-Cell ALL: A CIBMTR Analysis
Rangarajan, Hemalatha G. Satwani, Prakash Herr, Megan M. Chen, Min Martens, Michael J. Wudhikarn, Kitsada John, Samuel Fabrizio, Vanessa A. Hsieh, Emily M. Kelkar, Amar H.
Rangarajan, Hemalatha G.
Satwani, Prakash
Herr, Megan M.
Chen, Min
Martens, Michael J.
Wudhikarn, Kitsada
John, Samuel
Fabrizio, Vanessa A.
Hsieh, Emily M.
Kelkar, Amar H.
Author
Rangarajan, Hemalatha G.
Satwani, Prakash
Herr, Megan M.
Chen, Min
Martens, Michael J.
Wudhikarn, Kitsada
John, Samuel
Fabrizio, Vanessa A.
Hsieh, Emily M.
Kelkar, Amar H.
Doherty, Erin
Marks, David I.
Ringden, Olle
Friend, Brian D.
Kelly, Matthew S.
Farhadfar, Nosha
Prestidge, Timothy
Hossain, Nasheed M.
Liu, Hongtao
Hashmi, Shahrukh
Modi, Dipenkumar
Winestone, Lena E.
El Boghdadly, Zeinab
Murthy, Hemant S.
Perales, Miguel-Angel
Chemaly, Roy F.
Dandoy, Christopher E.
Hill, Joshua A.
Huppler, Anna R.
Riches, Marcie
Auletta, Jeff J.
Satwani, Prakash
Herr, Megan M.
Chen, Min
Martens, Michael J.
Wudhikarn, Kitsada
John, Samuel
Fabrizio, Vanessa A.
Hsieh, Emily M.
Kelkar, Amar H.
Doherty, Erin
Marks, David I.
Ringden, Olle
Friend, Brian D.
Kelly, Matthew S.
Farhadfar, Nosha
Prestidge, Timothy
Hossain, Nasheed M.
Liu, Hongtao
Hashmi, Shahrukh
Modi, Dipenkumar
Winestone, Lena E.
El Boghdadly, Zeinab
Murthy, Hemant S.
Perales, Miguel-Angel
Chemaly, Roy F.
Dandoy, Christopher E.
Hill, Joshua A.
Huppler, Anna R.
Riches, Marcie
Auletta, Jeff J.
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Department
Computer Vision
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Journal article
Date
2025
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English
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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 through 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 multivariable analysis, receipt of ≥3 lines of therapy prior to tisa-cel (hazard ratio [HR] 1.86, 95% CI 1.13-3.08, p=0.015), any grade cytokine release syndrome (HR 1.78, 95% CI 1.17-2.71, p=0.007), and lack of neutrophil recovery (HR 2.63, 95% CI 1.47-4.69, p=0.001) 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=0.01). Risk factors for viral infections included increasing age (1-year increase HR 1.05, 95% CI 1.01-1.09, p=0.016), prior history of any infection (HR 2.76, 95% CI 1.40-5.46, p=0.004), and prior hematopoietic cell transplant (HR 2.10, 95% CI 1.18-3.71, p=0.011). 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.
Citation
H. G. Rangarajan et al., “Real-World Outcomes of Infections Following Tisagenlecleucel in Patients with B-Cell ALL: A CIBMTR Analysis,” Blood Adv, Jul. 2025, doi: 10.1182/BLOODADVANCES.2025016149
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Blood Advances
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Publisher
American Society of Hematology