Evidence map›Paper›PMID 31650176›Full record

ArticleBlood2019

Toxicity and response after CD19-specific CAR T-cell therapy in pediatric/young adult relapsed/refractory B-ALL.

Kevin J Curran, Steven P Margossian, Nancy A Kernan, Lewis B Silverman, David A Williams, Neerav Shukla, Rachel Kobos, Christopher J Forlenza, Peter Steinherz, Susan Prockop and 16 more

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in Blood, 2019. 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 178 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
178citing papers in PubMed, 8 pooled it
13.5field-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.

NCT01860937 phase1active not recruitingnot on this map

A Phase I Trial of T-Lymphocytes Genetically Targeted to the B-Cell Specific Antigen CD19 in Pediatric and Young Adult Patients With Relapsed B-Cell Acute Lymphoblastic Leukemia

TypeinterventionalSponsorMemorial Sloan Kettering Cancer CenterRan2013 to 2027Enrolled23ConditionsRelapsed B-Cell Acute Lymphoblastic LeukemiaArmsleukapheresis or collection of PBMCs, cyclophosphamide based chemotherapy regimens, modified T cells
NCT07502118 phase2 / phase3recruitingnot on this mapstarted 2025, after this paper: background citation

An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed/Refractory B-Cell Malignancies (NexCAR19)

TypeinterventionalSponsorHealth Institutes of TurkeyRan2025 to 2030Enrolled40ConditionsRelapsed/Refractory B-cell Acute Lymphoblastic Leukemia (B-ALL), Relapsed/Refractory Non-Hodgkin Lymphoma, Diffuse Large B-Cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBCL)ArmsTalikabtagene Autoleucel
3 · Its place in the literature

Who cites it

178 citing papers in PubMed, 8 syntheses or guidelines pooled it, 273 citations in OpenAlex.

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 3 institutions in 1 country.

Kevin J CurranDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-3337-9956
Steven P MargossianDepartment of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA.
Nancy A KernanDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Lewis B SilvermanDepartment of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA.
David A WilliamsDepartment of Pediatric Oncology, Dana-Farber Cancer Institute, Boston, MA.
Neerav ShuklaDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Rachel KobosDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Christopher J ForlenzaDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Peter SteinherzDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Susan ProckopDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Farid BouladDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Barbara SpitzerDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Maria I CancioDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Jaap Jan BoelensDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0003-2232-6952
Andrew L KungDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Yasmin KhakooDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Victoria SzenesDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Jae H ParkCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Craig S SauterCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Glenn HellerDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.
Xiuyan WangCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Brigitte SenechalCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Richard J O'ReillyDepartment of Pediatrics, Memorial Sloan Kettering Cancer Center, New York, NY.
Isabelle RiviereCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Michel SadelainCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.ORCID 0000-0002-9031-8025
Renier J BrentjensCenter For Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, NY.
Memorial Sloan Kettering Cancer Center · USBoston Children's Hospital · USCancer Research And Biostatistics · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
T LYMPHOCYTE SUBSET FUNCTION POST-TRANSPLANTATIONP01CA023766 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SCHEINBERG, DAVID A · 1985 to 2023
$59.0M
STRONG HEART STUDY (SHS)- UNIVERSITY OF OKLAHOMA-FIELD CENTER (FC), TASK AREA B.3, YEAR 375N92019D00028 · NHLBI · UNIVERSITY OF OKLAHOMA HLTH SCIENCES CTR · PI ALI, TAUQEER · 2019 to 2025
$6.5M
PURPOSE OF THE NGVB CONTRACT IS TO CONTINUE SUPPORTING GENE THERAPY RESEARCH.75N92019D00018 · OD · INDIANA UNIVERSITY INDIANAPOLIS · 2019 to 2023
$1.7M
NCI NIH HHS P01 CA023766NCI NIH HHS P30 CA008748NHLBI NIH HHS 75N92019D00018NHLBI NIH HHS 75N92019D00028
6 · The paper itself

Abstract

Chimeric antigen receptor (CAR) T cells have demonstrated clinical benefit in patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). We undertook a multicenter clinical trial to determine toxicity, feasibility, and response for this therapy. A total of 25 pediatric/young adult patients (age, 1-22.5 years) with R/R B-ALL were treated with 19-28z CAR T cells. Conditioning chemotherapy included high-dose (3 g/m2) cyclophosphamide (HD-Cy) for 17 patients and low-dose (≤1.5 g/m2) cyclophosphamide (LD-Cy) for 8 patients. Fifteen patients had pretreatment minimal residual disease (MRD; <5% blasts in bone marrow), and 10 patients had pretreatment morphologic evidence of disease (≥5% blasts in bone marrow). All toxicities were reversible, including severe cytokine release syndrome in 16% (4 of 25) and severe neurotoxicity in 28% (7 of 25) of patients. Treated patients were assessed for response, and, among the evaluable patients (n = 24), response and peak CAR T-cell expansion were superior in the HD-Cy/MRD cohorts, as compared with the LD-Cy/morphologic cohorts without an increase in toxicity. Our data support the safety of CD19-specific CAR T-cell therapy for R/R B-ALL. Our data also suggest that dose intensity of conditioning chemotherapy and minimal pretreatment disease burden have a positive impact on response without a negative effect on toxicity. This trial was registered at www.clinicaltrials.gov as #NCT01860937.

Indexed as

Drug Resistance, NeoplasmAdolescentAdultAntigens, CD19ChildChild, PreschoolCytokine Release SyndromeFemaleHumansInfantMaleNeoplasm Recurrence, LocalNeoplasm, ResidualNeurotoxicity SyndromesPrecursor B-Cell Lymphoblastic Leukemia-LymphomaReceptors, Antigen, T-CellAntigens, CD19Receptors, Antigen, T-CellReceptors, Chimeric Antigen

Identifiers

PMID31650176
PMCPMC6933289
OpenAlexW2980400657

What OpenQuestion holds

Textmetadata
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.