Evidence map›Paper›PMID 29444231›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2018

Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

W Jurczak, P L Zinzani, G Gaidano, A Goy, M Provencio, Z Nagy, T Robak, K Maddocks, C Buske, S Ambarkhane and 4 more

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

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01685008 (A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-optimized Anti-CD19 Antibody, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma), which is not on this map. Cited by 78 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
78citing papers in PubMed, 3 pooled it
10.3field-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.

NCT01685008 phase2completednot on this map

A Phase IIa, Open-label, Multicenter Study of Single-agent MOR00208, an Fc-optimized Anti-CD19 Antibody, in Patients With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma

TypeinterventionalSponsorMorphoSys AGRan2013 to 2022Enrolled92ConditionsNon-Hodgkin LymphomaArmsMOR00208 (formerly Xmab 5574)
3 · Its place in the literature

Who cites it

78 citing papers in PubMed, 3 syntheses or guidelines pooled it, 130 citations in OpenAlex.

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  15. Sequencing of Anti-CD19 Therapies in the Management of Diffuse Large B-Cell Lymphoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
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18 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

14 authors at 10 institutions in 6 countries.

W JurczakDepartment of Hematology, Jagiellonian University, Kraków, Poland. Electronic address: wojciech.jurczak@uj.edu.pl.
P L ZinzaniInstitute of Hematology "L. e A. Seràgnoli", University of Bologna, Bologna.
G GaidanoDivision of Hematology, Department of Translational Medicine, University of Eastern Piedmont, Novara, Italy.
A GoyJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, USA.
M ProvencioDepartment of Medical Oncology, University Hospital Puerta De Hierro, Madrid, Spain.
Z NagyFirst Department of Internal Medicine, Semmelweis University, Budapest, Hungary.
T RobakDepartment of Hematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.
K MaddocksDivision of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, USA.
C BuskeComprehensive Cancer Center Ulm, Institute of Experimental Cancer Research, University Hospital of Ulm, Ulm.
S AmbarkhaneMorphoSys AG, Planegg, Germany.
M WinderlichMorphoSys AG, Planegg, Germany.
M Dirnberger-HertweckMorphoSys AG, Planegg, Germany.
R KorolkiewiczMorphoSys AG, Planegg, Germany.
K A BlumDivision of Hematology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, USA.
MorphoSys (Germany) · DEThe Ohio State University · USCopernicus Memorial Hospital · PLHackensack University Medical Center · USHospital Universitario Puerta de Hierro Majadahonda · ESJagiellonian University · PLSemmelweis University · HUUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITUniversity Hospital Ulm · DEUniversity of Bologna · IT

Funding

Development of a comprehensive research program in mantle cell lymphoma in the ibrutinib eraK24CA201524 · NCI · OHIO STATE UNIVERSITY · PI BLUM, KRISTIE A · 2015 to 2019
$886k
NCI NIH HHS K24 CA201524
6 · The paper itself

Abstract

Background: This two-stage, phase IIa study investigated the antitumor activity and safety of MOR208, an Fc-engineered, humanized, CD19 antibody, in patients with relapsed or refractory (R-R) B-cell non-Hodgkin's lymphoma (NHL). CD19 is broadly expressed across the B-lymphocyte lineage, including in B-cell malignancies, but not by hematological stem cells. Patients and methods: Patients aged ≥18 years, with R-R NHL progressing after ≥1 prior rituximab-containing regimen were enrolled into subtype-specific cohorts: diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), other indolent (i)NHL and mantle cell lymphoma (MCL). Treatment was MOR208, 12 mg/kg intravenously, weekly, for 8 weeks. Patients with at least stable disease could continue treatment for an additional 4 weeks. Those with a partial or complete response after 12 weeks could receive extended MOR208 treatment (12 mg/kg, either monthly or every second week) until progression. The primary end point was overall response rate. Results: Ninety-two patients were enrolled: DLBCL (n = 35), FL (n = 34), other iNHL (n = 11) and MCL (n = 12). Responses were observed in DLBCL, FL and other iNHL cohorts (26%, 29% and 27%, respectively). They lasted ≥12 months in 5/9 responding patients with DLBCL, 4/9 with FL and 2/3 with other iNHL. Responses in nine patients are ongoing (>26 months in five instances). Patients with rituximab refractory disease showed a similar response rate and progression-free survival time to patients with non-refractory disease. The most common adverse events (any grade) were infusion-related reactions (12%) and neutropenia (12%). One patient experienced a grade 4 infusion-related reaction and eight patients (9%) experienced grade 3/4 neutropenia. No treatment-related deaths were reported. Conclusions: MOR208 monotherapy demonstrated promising clinical activity in patients with R-R DLBCL and R-R FL, including in patients with rituximab refractory tumors. These efficacy data and the favorable safety profile support further investigation of MOR208 in phase II/III combination therapy trials in R-R DLBCL. ClinicalTrials.gov number: NCT01685008.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntigens, CD19Antineoplastic Agents, ImmunologicalDrug Resistance, NeoplasmFemaleHumansInjection Site ReactionLymphoma, B-CellMaleMiddle AgedNeoplasm Recurrence, LocalNeutropeniaProgression-Free SurvivalAntibodies, Monoclonal, HumanizedAntigens, CD19Antineoplastic Agents, ImmunologicalCD19 molecule, humanRituximabtafasitamab

Identifiers

PMID29444231
PMCPMC5961010
OpenAlexW2792232222

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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.