Evidence map›Paper›PMID 26755709›Full record

Trial reportBlood2016

Phase 2 study of the bispecific T-cell engager (BiTE) antibody blinatumomab in relapsed/refractory diffuse large B-cell lymphoma.

Andreas Viardot, Marie-Elisabeth Goebeler, Georg Hess, Svenja Neumann, Michael Pfreundschuh, Nicole Adrian, Florian Zettl, Martin Libicher, Cyrus Sayehli, Julia Stieglmaier and 3 more

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Blood, 2016. 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 210 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
210citing papers in PubMed, 6 pooled it
18.0field-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.

NCT01741792 phase2completednot on this map

An Open Label, Multicenter, Exploratory Phase 2 Study to Evaluate the Efficacy and Safety of the Bispecific T-Cell Engager (BiTE®) Blinatumomab in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

TypeinterventionalSponsorAmgen Research (Munich) GmbHRan2012 to 2015Enrolled25ConditionsDiffuse Large B-cell LymphomaArmsBlinatumomab
NCT07319676 phase1 / phase2recruitingnot on this mapstarted 2026, after this paper: background citation

Antigen Targeted T Cell Therapy for Relapsed/Refractory B Cell Lymphomas

TypeinterventionalSponsorNational University Hospital, SingaporeRan2026 to 2040Enrolled30ConditionsB-cell Lymphoma RefractoryArmsCART infusion
3 · Its place in the literature

Who cites it

210 citing papers in PubMed, 6 syntheses or guidelines pooled it, 362 citations in OpenAlex.

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  15. A Comprehensive Meta-Analysis of the Cardiovascular Adverse Effects of Bispecific Antibody Therapy in Hematologic Malignancies.Pathophysiology : the official journal of the International Society for Pathophysiology · 2026
    Review
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150 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

13 authors at 9 institutions in 2 countries.

Andreas ViardotDepartment of Internal Medicine III, University Hospital Ulm, Ulm, Germany;
Marie-Elisabeth GoebelerDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany;
Georg HessDepartment of Hematology, Oncology, and Pneumology, Johannes Gutenberg-University, Mainz, Germany;
Svenja NeumannMedical Department II, University Hospital Schleswig Holstein Campus Kiel, Kiel, Germany;
Michael PfreundschuhKlinik für Innere Medizin I, Saarland University Medical School, Homburg (Saar), Germany;
Nicole AdrianKlinik für Innere Medizin I, Saarland University Medical School, Homburg (Saar), Germany;
Florian ZettlUniversity Hospital Göttingen, Göttingen, Germany;
Martin LibicherDepartment of Radiology, Diakoniekrankenhaus Schwäbisch-Hall, Schwäbisch-Hall, Germany;
Cyrus SayehliDepartment of Internal Medicine II, University Hospital Würzburg, Würzburg, Germany;
Julia StieglmaierAmgen Research (Munich), Munich, Germany;
Alicia ZhangAmgen Inc, Thousand Oaks, CA; and.
Dirk NagorsenAmgen Inc, Thousand Oaks, CA; and.
Ralf C BargouComprehensive Cancer Center Mainfranken, University Hospital Würzburg, Würzburg, Germany.
Universitätsklinikum Würzburg · DEAmgen (United States) · USSaarland University · DEAmgen (Germany) · DEEvangelisches Diakoniekrankenhaus · DEJohannes Gutenberg University Mainz · DEUniversitätsmedizin Göttingen · DEUniversity Hospital Ulm · DEUniversity of Lübeck · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Few patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) achieve prolonged disease-free survival. Blinatumomab, a bispecific T-cell engaging antibody construct, transiently links CD3-positive T cells to CD19-positive B cells. This phase 2 study evaluated stepwise (9-28-112 μg/d with weekly dose increases; n = 23) or flat (112 μg/d; n = 2) dosing of blinatumomab by continuous infusion, with dexamethasone prophylaxis, in patients with relapsed/refractory DLBCL. Patients received a median of 3 prior lines of therapy. Median time since last regimen was 1.5 months. Seventeen patients ended treatment in cycle 1 (induction), 7 in cycle 2 (consolidation), and 1 in retreatment. Among 21 evaluable patients, the overall response rate after 1 blinatumomab cycle was 43%, including complete responses (CRs) in 19%. Three patients had late CR in follow-up without other treatment. The most common adverse events with stepwise dosing were tremor (48%), pyrexia (44%), fatigue (26%), and edema (26%). Grade 3 neurologic events with stepwise dosing were encephalopathy and aphasia (each 9%) and tremor, speech disorder, dizziness, somnolence, and disorientation (each 4%). Of 5 (22%) patients who discontinued stepwise dosing because of adverse events, 4 (17%) had neurologic events. Most neurologic events resolved. The flat-dose cohort was stopped because of grade 3 neurologic events in both patients. Blinatumomab monotherapy appears effective in patients with relapsed/refractory DLBCL, a heavily pretreated patient population with a high unmet medical need. Further studies need to define the optimal approach to achieve the target dose without early dropout. The study was registered at www.clinicaltrials.gov as #NCT01741792.

Indexed as

ImmunotherapyMolecular Targeted TherapyAdultAgedAntibodies, BispecificAntigens, CD19Antigens, NeoplasmAntineoplastic AgentsCD3 ComplexDexamethasoneDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFeverAntibodies, BispecificAntigens, CD19Antigens, NeoplasmAntineoplastic AgentsblinatumomabCD3 ComplexDexamethasone

Identifiers

PMID26755709
PMCPMC4797019
OpenAlexW2236959863

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.