Evidence map›Paper›PMID 38625984›Full record

Trial reportBlood advances2024

Tabelecleucel for EBV+ PTLD after allogeneic HCT or SOT in a multicenter expanded access protocol.

Sarah Nikiforow, Jennifer S Whangbo, Ran Reshef, Donald E Tsai, Nancy Bunin, Rolla Abu-Arja, Kris Michael Mahadeo, Wen-Kai Weng, Koen Van Besien, David Loeb and 10 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyClinical Trial
In one paragraph

Trial report in Blood advances, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02822495 (Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies), which is not on this map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
4.8field-weighted citation impact, top 4% 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.

NCT02822495 no longer availablenot on this map

Expanded Access Protocol for Providing Tabelecleucel to Patients With Epstein-Barr Virus-Associated Viremia or Malignancies for Whom There Are No Appropriate Alternative Therapies

Typeexpanded_accessSponsorAtara BiotherapeuticsConditionsEpstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Armstabelecleucel
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
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  6. Review
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  8. Viral oncogenesis in cancer: from mechanisms to therapeutics.Signal transduction and targeted therapy · 2025
    Review
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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

20 authors at 12 institutions in 1 country.

Sarah NikiforowDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.
Jennifer S WhangboVOR Bio, Cambridge, MA.ORCID 0000-0002-5759-2532
Ran ReshefBlood and Marrow Transplantation and Cell Therapy Program, Columbia University Irving Medical Center, New York, NY.ORCID 0000-0003-2185-9546
Donald E TsaiDepartment of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Nancy BuninDivision of Pediatric Hematology/Oncology and Blood and Marrow Transplant, Children's Hospital of Philadelphia, Philadelphia, PA.ORCID 0000-0001-6210-2262
Rolla Abu-ArjaDivision of Pediatric Hematology/Oncology and Blood and Marrow Transplant, Nationwide Children's Hospital, Columbus, OH.ORCID 0000-0001-9768-7520
Kris Michael MahadeoDivision of Pediatric Transplant and Cellular Therapy, Duke University Medical Center, Durham, NC.ORCID 0000-0003-2649-9674
Wen-Kai WengBMT-Cellular Therapy, Department of Medicine, Stanford University, School of Medicine, Stanford, CA.
Koen Van BesienDepartment of Medicine, University Hospitals Seidman Cancer Center, Cleveland, OH.ORCID 0000-0002-8164-6211
David LoebLymphoma Program, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Sunita Dwivedy NastaDepartment of Medicine, Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA.
Eneida R NemecekPediatric Transplant & Cellular Therapy, Oregon Health and Science University, Portland, OR.
Weizhi ZhaoAtara Biotherapeutics, Thousand Oaks, CA.
Yan SunAtara Biotherapeutics, Thousand Oaks, CA.
Faith GalderisiAtara Biotherapeutics, Thousand Oaks, CA.
Justin WahlstromAtara Biotherapeutics, Thousand Oaks, CA.
Aditi MehtaAtara Biotherapeutics, Thousand Oaks, CA.
Laurence GamelinAtara Biotherapeutics, Thousand Oaks, CA.
Rajani DinavahiAtara Biotherapeutics, Thousand Oaks, CA.
Susan ProckopDepartment of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA.ORCID 0000-0003-4175-5728
Atara Biotherapeutics (United States) · USBoston Children's Hospital · USUniversity of Pennsylvania · USChildren's Hospital at Montefiore · USChildren's Hospital of Philadelphia · USColumbia University Irving Medical Center · USCornell University · USDana-Farber Cancer Institute · USDuke Medical Center · USNationwide Children's Hospital · USOregon Health & Science University · USStanford University · US

Funding

Tumor Biology and Microenvironment ProgramP30CA013696 · NCI · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI Anil K Rustgi · 1985 to 2026
$115.3M
Multidisciplinary Training in Gastrointestinal CancersT32CA285274 · NCI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Julian Abrams, Anil K Rustgi · 2024 to 2026
$897k
NCI NIH HHS P30 CA013696NCI NIH HHS T32 CA285274
6 · The paper itself

Abstract

abstractPatients with Epstein-Barr virus (EBV)-positive posttransplant lymphoproliferative disease (EBV+ PTLD) in whom initial treatment fails have few options and historically low median overall survival (OS) of 0.7 months after allogeneic hematopoietic cell transplant (HCT) and 4.1 months after solid organ transplant (SOT). Tabelecleucel is an off-the-shelf, allogeneic EBV-specific cytotoxic T-lymphocyte immunotherapy for EBV+ PTLD. Previous single-center experience showed responses in patients with EBV+ PTLD after HCT or SOT. We now report outcomes from a multicenter expanded access protocol in HCT (n = 14) and SOT (n = 12) recipients treated with tabelecleucel for EBV+ PTLD that was relapsed/refractory (R/R) to rituximab with/without chemotherapy. The investigator-assessed objective response rate was 65.4% overall (including 38.5% with a complete and 26.9% with a partial response), 50.0% in HCT, and 83.3% in SOT. The estimated 1- and 2-year OS rates were both 70.0% (95% confidence interval [CI], 46.5-84.7) overall, both 61.5% (95% CI, 30.8-81.8) in HCT, and both 81.5% (95% CI, 43.5-95.1) in SOT (median follow-up: 8.2, 2.8, and 22.5 months, respectively). Patients responding to tabelecleucel had higher 1- and 2-year OS rates (94.1%) than nonresponders (0%). Treatment was well tolerated, with no reports of tumor flare, cytokine release syndrome, or rejection of marrow and SOT. Results demonstrate clinically meaningful outcomes across a broad population treated with tabelecleucel, indicating a potentially transformative and accessible treatment advance for R/R EBV+ PTLD after HCT or SOT. This trial was registered at www.ClinicalTrials.gov as #NCT02822495.

Indexed as

Epstein-Barr Virus InfectionsHematopoietic Stem Cell TransplantationLymphoproliferative DisordersTransplantation, HomologousAdultAgedFemaleHerpesvirus 4, HumanHumansMaleMiddle AgedOrgan TransplantationTreatment OutcomeYoung Adult

Identifiers

PMID38625984
PMCPMC11215195
OpenAlexW4394856551

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.