Evidence map›Paper›PMID 33764809›Full record

ArticleJournal of clinical oncology : official journal of the American Society of Clinical Oncology2021

Long-Term Follow-Up of CD19-CAR T-Cell Therapy in Children and Young Adults With B-ALL.

Nirali N Shah, Daniel W Lee, Bonnie Yates, Constance M Yuan, Haneen Shalabi, Staci Martin, Pamela L Wolters, Seth M Steinberg, Eva H Baker, Cindy P Delbrook and 4 more

2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 232 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
232citing papers in PubMed, 4 pooled it
26.5field-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.

NCT01593696 phase1completednot on this map

Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Malignancies

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2017Enrolled53ConditionsALL, B Cell Lymphoma, Leukemia, Large Cell LymphomaArmsAnti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR)
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

232 citing papers in PubMed, 4 syntheses or guidelines pooled it, 346 citations in OpenAlex.

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  5. Three-Year Update of Tisagenlecleucel in Pediatric and Young Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia in the ELIANA Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
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  19. CDK4/6 inhibition enhances CAR-T cell therapy in solid tumors.Molecular therapy : the journal of the American Society of Gene Therapy · 2026
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172 more citing papers are in PubMed but not listed here.

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

14 authors at 4 institutions in 1 country.

Nirali N ShahPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0002-8474-9080
Daniel W LeePediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0002-3249-9796
Bonnie YatesPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.
Constance M YuanLaboratory of Pathology, CCR, NCI, NIH, Bethesda, MD.ORCID 0000-0002-2601-3665
Haneen ShalabiPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.
Staci MartinPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.
Pamela L WoltersPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0001-9319-6281
Seth M SteinbergBiostatistics and Data Management Section, Office of the Clinical Director, Center for Cancer Research, Bethesda, MD.ORCID 0000-0002-8280-551X
Eva H BakerDepartment of Radiology and Imaging Sciences, NIH Clinical Center, Bethesda, MD.
Cindy P DelbrookPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0001-6916-4925
Maryalice Stetler-StevensonLaboratory of Pathology, CCR, NCI, NIH, Bethesda, MD.
Terry J FryPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0001-8044-5226
David F StroncekCenter for Cellular Engineering, Department of Transfusion Medicine, NIH Clinical Center, Bethesda, MD.ORCID 0000-0001-5867-3265
Crystal L MackallPediatric Oncology Branch, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH, Bethesda, MD.ORCID 0000-0003-0359-9023
National Cancer Institute · USCenter for Cancer Research · USNational Institutes of Health Clinical Center · USChildren's Hospital Colorado · US

Funding

Translational Oncology Research Program (Project-005)P30CA124435 · NCI · STANFORD UNIVERSITY · PI Melinda L. Telli · 2007 to 2026
$71.4M
Office of Collaborative BiostatisticsZIDSC007202 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI CHOO-WOSOBA, HYOYOUNG · 2009 to 2025
$14.5M
Flow Cytometric Evaluation of BiomarkersZICBC011104 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI WANG, HAO-WEI · 2009 to 2025
$8.6M
Immunotherapeutic approaches to treat pediatric hematologic malignanciesZIABC011823 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI SHAH, NIRALI · 2019 to 2025
$6.1M
Clinical Trials of Immunotherapies for Childhood CancerZIABC011498 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MACKALL, CRYSTAL · 2013 to 2015
$2.9M
Development of novel cell and gene therapiesZIACL002120 · CLC · CLINICAL CENTER · PI STRONCEK, DAVID · 2009 to 2025
$0k
Intramural NIH HHS ZIA BC011498Intramural NIH HHS ZIA BC011823NCI NIH HHS P30 CA124435
6 · The paper itself

Abstract

purposeCD19 chimeric antigen receptor (CD19-CAR) T cells induce high response rates in children and young adults (CAYAs) with B-cell acute lymphoblastic leukemia (B-ALL), but relapse rates are high. The role for allogeneic hematopoietic stem-cell transplant (alloHSCT) following CD19-CAR T-cell therapy to improve long-term outcomes in CAYAs has not been examined.

methodsWe conducted a phase I trial of autologous CD19.28ζ-CAR T cells in CAYAs with relapsed or refractory B-ALL. Response and long-term clinical outcomes were assessed in relation to disease and treatment variables.

resultsFifty CAYAs with B-ALL were treated (median age, 13.5 years; range, 4.3-30.4). Thirty-one (62.0%) patients achieved a complete remission (CR), 28 (90.3%) of whom were minimal residual disease-negative by flow cytometry. Utilization of fludarabine/cyclophosphamide-based lymphodepletion was associated with improved CR rates (29/42, 69%) compared with non-fludarabine/cyclophosphamide-based lymphodepletion (2/8, 25%;

conclusionWe provide the longest follow-up in CAYAs with B-ALL after CD19-CAR T-cell therapy reported to date and demonstrate that sequential therapy with CD19.28ζ-CAR T cells followed by alloHSCT can mediate durable disease control in a sizable fraction of CAYAs with relapsed or refractory B-ALL (ClinicalTrials.gov identifier: NCT01593696).

Indexed as

AdolescentAdultChildChild, PreschoolFemaleFollow-Up StudiesHumansImmunotherapy, AdoptiveMalePrecursor B-Cell Lymphoblastic Leukemia-LymphomaYoung Adult

Identifiers

PMID33764809
PMCPMC8274806
OpenAlexW3138004978

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.