Evidence map›Paper›PMID 35167655›Full record

Trial reportBlood2022

Safety and efficacy of tisagenlecleucel in primary CNS lymphoma: a phase 1/2 clinical trial.

Matthew J Frigault, Jorg Dietrich, Kathleen Gallagher, Mark Roschewski, Justin T Jordan, Deborah Forst, Scott R Plotkin, Daniella Cook, Keagan S Casey, Kevin A Lindell and 17 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Blood, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02445248 (A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma), which is not on this map. Cited by 96 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 3 pooled it
13.1field-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.

NCT02445248 phase2completednot on this map

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2015 to 2022Enrolled115ConditionsDiffuse Large B-cell Lymphoma (DLBCL)ArmsTisagenlecleucel, Lymphodepleting chemotherapy
3 · Its place in the literature

Who cites it

96 citing papers in PubMed, 3 syntheses or guidelines pooled it, 134 citations in OpenAlex.

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  9. Targeting Adaptive and Innate Immune Responses with Covalent Aptamers.Journal of the American Chemical Society · 2026
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36 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 4 institutions in 1 country.

Matthew J FrigaultHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-6774-5694
Jorg DietrichDivision of Neuro-Oncology, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Kathleen GallagherCellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA.
Mark RoschewskiLymphoid Malignancies Branch, National Cancer Institute, Bethesda, MD.ORCID 0000-0003-0278-2635
Justin T JordanDivision of Neuro-Oncology, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0001-6198-817X
Deborah ForstDivision of Neuro-Oncology, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-8428-0841
Scott R PlotkinDivision of Neuro-Oncology, Department of Neurology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-6109-6419
Daniella CookHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Keagan S CaseyHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Kevin A LindellHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Gabriel D DepinhoHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Katelin KatsisCellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA.
Eva Lynn ElderCellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA.
Mark B LeickHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0003-3111-0221
Bryan ChoiCellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA.
Nora HorickCellular Immunotherapy Program, Massachusetts General Hospital, Boston, MA.
Frederic PrefferDepartment of Pathology, Massachusetts General Hospital, Boston, MA; and.
Meredith SaylorHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Steven McAfeeHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Paul V O'DonnellHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Thomas R SpitzerHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Bimalangshu DeyHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Zachariah DeFilippHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-7994-8974
Areej El-JawahriHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Tracy T BatchelorDepartment of Neurology, Brigham's and Women Hospital & Dana Farber Harvard Cancer Institute, Boston, MA.
Marcela V MausHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-7578-0393
Yi-Bin ChenHematopoietic Cell Transplant and Cellular Therapy Program, Massachusetts General Hospital and Harvard Medical School, Boston, MA.ORCID 0000-0002-9554-1058
Harvard University · USMassachusetts General Hospital · USDana-Farber Brigham Cancer Center · USNational Cancer Institute · US

Funding

Dana Farber/Harvard Cancer Consortium Career Development Program in Clinical OncologyK12CA087723 · NCI · MASSACHUSETTS GENERAL HOSPITAL · PI David Tsai Ting · 2002 to 2026
$17.9M
Pathway inhibitors in LymphomasZIABC011916 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSCHEWSKI, MARK · 2019 to 2025
$6.5M
Molecular Biology of LymphomaZIABC011914 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI ROSCHEWSKI, MARK · 2019 to 2025
$5.5M
NCI NIH HHS K12 CA087723
6 · The paper itself

Abstract

CD19-directed chimerical antigen receptor T-cell (CAR-T) products have gained US Food and Drug Administration approval for systemic large B-cell lymphoma. Because of concerns about potential immune cell-associated neurotoxicity syndrome (ICANS), patients with primary central nervous system (CNS) lymphoma (PCNSL) were excluded from all pivotal CAR-T studies. We conducted a phase 1/2 clinical trial of tisagenlecleucel in a highly refractory patients with PCNSL and significant unmet medical need. Here, we present results of 12 relapsed patients with PCNSL who were treated with tisagenlecleucel and followed for a median time of 12.2 months (range, 3.64-23.5). Grade 1 cytokine release syndrome was observed in 7/12 patients (58.3%), low-grade ICANS in 5/12 (41.6%) patients, and only 1 patient experienced grade 3 ICANS. Seven of 12 patients (58.3%) demonstrated response, including a complete response in 6/12 patients (50%). There were no treatment-related deaths. Three patients had ongoing complete remission at data cutoff. Tisagenlecleucel expanded in the peripheral blood and trafficked to the CNS. Exploratory analysis identified T-cell, CAR T, and macrophage gene signatures in cerebrospinal fluid following infusion when compared with baseline. Overall, tisagenlecleucel was well tolerated and resulted in a sustained remission in 3/7 (42.9%) of initial responders. These data suggest that tisagenlecleucel is safe and effective in this highly refractory patient population. This trial was registered at www.clinicaltrials.gov as #NCT02445248.

Indexed as

Central Nervous System NeoplasmsImmunotherapy, AdoptiveLymphomaReceptors, Antigen, T-CellAntigens, CD19HumansReceptors, Chimeric AntigenAntigens, CD19Receptors, Antigen, T-CellReceptors, Chimeric Antigentisagenlecleucel

Identifiers

PMID35167655
PMCPMC9012129
OpenAlexW4213165752

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.