Evidence map›Paper›PMID 40737539›Full record

ArticleBlood advances2025

Real-world outcomes of infections following tisagenlecleucel in patients with B-cell ALL: a CIBMTR analysis.

Hemalatha G Rangarajan, Prakash Satwani, Megan M Herr, Min Chen, Michael J Martens, Kitsada Wudhikarn, Samuel John, Vanessa A Fabrizio, Emily M Hsieh, Amar H Kelkar and 21 more

Abstract read
In one paragraph

Article in Blood advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Guideline
  2. Review
  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

31 authors.

Hemalatha G RangarajanDepartment of Pediatric Hematology, Oncology, and Blood and Marrow Transplantation, Nationwide Children's Hospital, Columbus, OH.ORCID 0000-0003-3371-2920
Prakash SatwaniDepartment of Pediatrics, Columbia University Medical Center, New York, NY.
Megan M HerrDepartment of Medicine, Roswell Park Comprehensive Cancer Center, Buffalo, NY.ORCID 0000-0001-5768-9396
Min ChenCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.
Michael J MartensCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0003-3799-681X
Kitsada WudhikarnCenter of Excellence in Translational Hematology and Division of Hematology, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Samuel JohnDivision of Pediatric Hematology-Oncology, University of Texas Southwestern Medical Center, Dallas, TX.
Vanessa A FabrizioDepartment of Pediatric Hematology, Oncology, and Bone Marrow Transplant, University of Colorado Anschutz, Aurora, CO.
Emily M HsiehDivision of Hematology/Oncology/Transplantation & Cellular Therapy, Children's Hospital Los Angeles, Keck School of Medicine of University of Southern California, Los Angeles, CA.
Amar H KelkarDepartment of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.ORCID 0000-0001-7627-8509
Erin DohertyDepartment of Pediatrics, Center for Cell and Gene Therapy, Texas Children's Hospital/Baylor College of Medicine, Houston, TX.
David I MarksDepartment of Hematology, Bristol Hematology and Oncology Unit, University of Bristol, Bristol, United Kingdom.
Olle RingdenDepartment of Clinical Science, Intervention and Technology, Translational Cell Therapy Group, Karolinska Institute, Stockholm, Sweden.ORCID 0000-0002-6092-1536
Brian FriendDepartment of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0001-8652-4400
Matthew S KellyDivision of Pediatric Infectious Diseases, Duke University Medical Center, Durham, NC.ORCID 0000-0001-8819-2315
Nosha FarhadfarDivision of Hematology, Sarah Cannon Transplant & Cellular Program at Methodist Hospital, San Antonio, TX.
Tim PrestidgeDepartment of Blood and Cancer, Blood and Cancer Centre, Starship Children's Hospital, Auckland, New Zealand.ORCID 0000-0003-4078-5001
Nasheed M HossainDivision of Hematology/Oncology - Cell Therapy and Transplantation Program, Department of Medicine, University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA.ORCID 0000-0002-3278-655X
Hongtao LiuDivision of Hematology, Medical Oncology and Palliative Care, Department of Medicine, University of Wisconsin-Madison, Madison, WI.ORCID 0000-0002-3190-7807
Shahrukh HashmiDepartment of Medicine, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates.ORCID 0000-0002-8914-7927
Dipenkumar ModiDivision of Oncology, Karmanos Cancer Center, Wayne State University, Detroit, MI.ORCID 0000-0001-6525-8844
Lena E WinestoneDivision of Allergy, Immunology, and Blood & Marrow Transplant, University of California San Francisco Benioff Children's Hospitals, San Francisco, CA.ORCID 0000-0001-9982-1594
Zeinab El BoghdadlyDivision of Infectious Diseases, Department of Internal Medicine, The Ohio State University Wexner Medical Center, Columbus, OH.
Hemant S MurthyDivision of Hematology/Oncology, Mayo Clinic Florida, Jacksonville, FL.ORCID 0000-0003-4534-4248
Miguel-Angel PeralesAdult Bone Marrow Transplant Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-5910-4571
Roy F ChemalyDepartment of Pediatrics, The University of Texas MD Anderson Cancer Center, Houston, TX.ORCID 0000-0002-0277-3088
Christopher E DandoyDivision of Bone Marrow Transplantation and Immune Deficiency, Cancer and Blood Disease Institute, Cincinnati Children's Hospital Medical Center, University of Cincinnati School of Medicine, Cincinnati, OH.ORCID 0000-0002-4001-9203
Joshua A HillVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, WA.ORCID 0000-0003-0942-9834
Anna HupplerCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.ORCID 0000-0003-1263-6623
Marcie RichesCenter for International Blood and Marrow Transplant Research, Medical College of Wisconsin, Milwaukee, WI.
Jeffery J AulettaCenter for International Blood and Marrow Transplant Research, National Marrow Donor Program, Minneapolis, MN.ORCID 0000-0002-1515-2141

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SELWYN M VICKERS · 1985 to 2026
$347.4M
Data Resource for Analyzing Blood &Marrow TransplantsU24CA076518 · NCI · MEDICAL COLLEGE OF WISCONSIN · PI Amy M Moskop, Bronwen Shaw · 1998 to 2026
$105.2M
Blood and Marrow Transplant Clinical Trials Network DCC- The Medical College of Wisconsin, Inc.U24HL138660 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI Steven M. DeVine, Mehdi Hussain Hamadani · 2017 to 2026
$71.4M
Therapeutic Potential of Adaptive NK Cells in Cancer and TransplantationP01CA111412 · NCI · UNIVERSITY OF MINNESOTA TWIN CITIES · PI MILLER, JEFFREY S. · 2005 to 2025
$38.2M
Cure Sickle CellOT3HL147741 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI MARY EAPEN, Mary Maresca Horowitz · 2018 to 2026
$37.7M
Hematopopietic Stem Cell TransplantationU01AI069197 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Effie W Petersdorf · 2005 to 2026
$18.9M
Clinical Significance of MHC Haplotypes in Hematopoietic Cell TransplantationR01CA100019 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI PETERSDORF, EFFIE W · 2003 to 2025
$9.1M
Immuno and Epigenetics of Hematopoietic Cell TransplantationR01CA218285 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Effie W Petersdorf · 2017 to 2026
$5.6M
1/2A Phase III Randomized Trial Comparing Unrelated Donor Bone Marrow Transplantation with Immune Suppressive Therapy for Newly Diagnosed Pediatric and Young Adult Patients with Severe Aplastic AnemiaU24HL157560 · NHLBI · MEDICAL COLLEGE OF WISCONSIN · PI SHAW, BRONWEN · 2022 to 2025
$5.0M
Integrated Exchange and Storage of Current- and Future-Generation Immunogenomic DataR01AI128775 · NIAID · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI JILL Allison HOLLENBACH, STEVEN JOHN MACK · 2017 to 2026
$4.5M
NTP INFORMATION SYSTEMS SUPPORT27305C0011 · NIEHS · Z-TECH CORPORATION · 2007 to 2009
$4.3M
Immunogenetics of Outcomes Disparities After Allogeneic HCTR01CA231838 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Effie W Petersdorf · 2018 to 2026
$3.7M
CLC NIH HHS C0000008NCI NIH HHS P01 CA111412NCI NIH HHS P30 CA008748NCI NIH HHS R01 CA100019NCI NIH HHS R01 CA218285NCI NIH HHS R01 CA231838NCI NIH HHS R01 CA262899NCI NIH HHS U24 CA076518NHLBI NIH HHS OT3 HL147741NHLBI NIH HHS R01 HL155741NHLBI NIH HHS R01 HL171117NHLBI NIH HHS U24 HL138660NHLBI NIH HHS U24 HL157560NHLBI NIH HHS UG1 HL174426NIAID NIH HHS R01 AI128775NIAID NIH HHS R01 AI150999NIAID NIH HHS R01 AI158861NIAID NIH HHS U01 AI069197NIAID NIH HHS U01 AI184132NIA NIH HHS R21 AG077024NIEHS NIH HHS 27305C0011NIEHS NIH HHS 27307C0009NIEHS NIH HHS 27307C0011NIEHS NIH HHS 27398C0011
6 · The paper itself

Abstract

abstractTisagenlecleucel (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.

Indexed as

Immunotherapy, AdoptiveInfectionsPrecursor B-Cell Lymphoblastic Leukemia-LymphomaReceptors, Antigen, T-CellAdolescentAdultChildChild, PreschoolFemaleHumansMaleTreatment OutcomeYoung AdultReceptors, Antigen, T-Celltisagenlecleucel

Identifiers

PMID40737539
PMCPMC12607035

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LicenceCC BY-NC-ND
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.