Observational studyJournal for immunotherapy of cancer2025
Classification of patients with relapsed/refractory large B-cell lymphoma who do not develop early CRS/NE toxicity using ZUMA clinical trial data.
Observational study in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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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.
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.
Who cites it
2 citing papers in PubMed.
- Predictive Models for Toxicities after CAR T-cell Therapy: Challenges and Opportunities.Blood cancer discovery · 2026Review
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWe aimed to develop an actionable and feasible prospective clinical model to estimate toxicity risk to assist chimeric antigen receptor (CAR) T-cell therapy providers with the management of patients with relapsed and/or refractory large B-cell lymphoma.
methodsWe conducted an observational, retrospective cohort study using secondary data from 390 patients treated with the CD19 CAR T-cell therapy axicabtagene ciloleucel under two prospective clinical trials, ZUMA-1 and ZUMA-7; these clinical trials enrolled patients with relapsed/refractory large B-cell lymphoma between 2015 and 2019. Using machine learning and statistical methods, we developed a classification model for identifying patients unlikely to experience early cytokine release syndrome (CRS) and neurological events (NE) of any grade.
resultsWe found the use of prophylactic corticosteroids to be an important factor in remaining CRS-free and NE-free within the first 3 days post-treatment (p<0.001). We identified a top model for no early CRS/NE using a set of six pre-lymphodepletion clinicopathologic features: number of lines of prior systemic therapy, age, baseline tumor burden (as measured by sum of the product of the diameters), C-reactive protein, aspartate transaminase, and hemoglobin, which achieves a positive predictive value of 0.71 in the holdout validation cohort. Additionally, we find that predicted probabilities generated from the model are strongly associated with incidence of Grade 2 or higher NE.
conclusionsWe illustrated that routine clinicopathologic variables can be used to identify patients at low risk of developing early post-treatment CRS and/or NE. Such knowledge can be used to help treating centers prospectively manage patient care, including consideration of outpatient treatment.
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Registered trials
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.