Evidence map›Paper›PMID 29499750›Full record

ReviewJournal of hematology & oncology2018

Grading of cytokine release syndrome associated with the CAR T cell therapy tisagenlecleucel.

David Porter, Noelle Frey, Patricia A Wood, Yanqiu Weng, Stephan A Grupp

Erratum issued 2 registry-linked trialsOpen access · goldAbstract readReview
In one paragraph

Review in Journal of hematology & oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 184 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
184citing papers in PubMed, 5 pooled it
23.2field-weighted citation impact, top 1% of its field
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.

NCT03790891 early_phase1unknown statusnot on this mapstarted 2019, after this paper: background citation

Adoptive Immunotherapy for Non-Hodgkin Lymphoma With CD19-TriCAR-T/SILK Cell

TypeinterventionalSponsorTimmune Biotech Inc.Ran2019 to 2022Enrolled12ConditionsNon-Hodgkin LymphomaArmsCD19-TriCAR-T/SILK
NCT04374149 phase2completednot on this mapstarted 2020, after this paper: background citation

Interventional Study to Evaluate the Efficacy of Therapeutic Plasma Exchange (TPE) Alone or in Combination With Ruxolitinib in COVID-19 Positive Patients With PENN Grade 2, 3, 4 Cytokine Released Syndrome (CRS)

TypeinterventionalSponsorPrisma Health-UpstateRan2020 to 2020Enrolled20ConditionsCytokine Release Syndrome, COVID19ArmsTherapeutic Plasma Exchange, Ruxolitinib
3 · Its place in the literature

Who cites it

184 citing papers in PubMed, 5 syntheses or guidelines pooled it, 401 citations in OpenAlex.

  1. Pooled it
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  6. Trial
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  9. Optimizing Chimeric Antigen Receptor T-Cell Therapy for Adults With Acute Lymphoblastic Leukemia.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2020
    Trial
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  12. Article
  13. Humoral immunity in cancer.Signal transduction and targeted therapy · 2026
    Review
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  17. Beyond the infusion: nursing at the vanguard of cytokine release syndrome rescue in CAR-T cell therapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
  18. Article
  19. Review
  20. Article

124 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 3 institutions in 1 country.

David PorterDivision of Hematology-Oncology, Blood and Marrow Transplantation and Cellular Therapy Program, Perelman School of Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA. David.Porter@uphs.upenn.edu.
Noelle FreyDivision of Hematology-Oncology, Blood and Marrow Transplantation and Cellular Therapy Program, Perelman School of Medicine and Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.
Patricia A WoodNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Yanqiu WengNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
Stephan A GruppDepartment of Pediatrics, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.
Novartis (United States) · USUniversity of Pennsylvania · USPhiladelphia University · US

Funding

Project 3: Combinatorial and gene-editing approaches to enhance the efficacy of CAR T cell therapy of multiple myeloma.P01CA214278 · NCI · UNIVERSITY OF PENNSYLVANIA · PI CARL H. JUNE · 2017 to 2026
$26.8M
CD19 Directed CAR TherapyR01CA165206 · NCI · UNIVERSITY OF PENNSYLVANIA · PI JUNE, CARL H., PORTER, DAVID L · 2012 to 2016
$2.2M
NCI NIH HHS P01 CA214278NCI NIH HHS R01 CA165206
6 · The paper itself

Abstract

backgroundAnti-CD19 CAR T cell therapy has demonstrated high response rates in patients with relapsed or refractory (r/r) B cell malignancies but is associated with significant toxicity. Cytokine release syndrome (CRS) is the most significant complication associated with CAR T cell therapy, and it is critical to have a reproducible and easy method to grade CRS after CAR T cell infusions. DISCUSSION: The Common Terminology Criteria for Adverse Events scale is inadequate for grading CRS associated with cellular therapy. Clinical experience with the anti-CD19 CAR T cell therapy tisagenlecleucel at the University of Pennsylvania (Penn) was used to develop the Penn grading scale for CRS. The Penn grading scale depends on easily accessible clinical features; does not rely on location of care or quantitation of supportive care; assigns grades to guide CRS management; distinguishes between mild, moderate, severe, and life-threatening CRS; and applies to both early-onset and delayed-onset CRS associated with T cell therapies. Clinical data from 55 pediatric patients with r/r B cell acute lymphoblastic leukemia and 42 patients with r/r chronic lymphocytic lymphoma treated with tisagenlecleucel were used to demonstrate the current application of the Penn grading scale.

conclusionWe show that the Penn grading scale provides reproducible CRS grading that can be useful to guide therapy and that can be applied across clinical trials and treatment platforms.

Indexed as

AnimalsCytokinesHumansImmunotherapy, AdoptiveInflammationLeukemia, B-CellLeukemia, Lymphocytic, Chronic, B-CellReceptors, Antigen, T-CellCytokinesReceptors, Antigen, T-CelltisagenlecleucelCAR T cell therapyCytokine release syndromeSafety

Identifiers

PMID29499750
PMCPMC5833070
OpenAlexW2793787928

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.