Evidence map›Paper›PMID 28220479›Full record

Trial reportBritish journal of haematology2017

A phase 1/2 trial of ublituximab, a novel anti-CD20 monoclonal antibody, in patients with B-cell non-Hodgkin lymphoma or chronic lymphocytic leukaemia previously exposed to rituximab.

Ahmed Sawas, Charles M Farber, Marshall T Schreeder, Mazen Y Khalil, Daruka Mahadevan, Changchun Deng, Jennifer E Amengual, Petros G Nikolinakos, Jill M Kolesar, John G Kuhn and 3 more

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

Trial report in British journal of haematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04508647 (Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response), which is not on this map. Cited by 44 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed, 1 pooled it
5.5field-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.

NCT04508647 phase2completednot on this mapstarted 2020, after this paper: background citation

Ublituximab as Initial Therapy for Treatment-naive Follicular or Marginal Zone Lymphoma With Response-driven Addition of Umbralisib for Suboptimal Response

TypeinterventionalSponsorUniversity of Colorado, DenverRan2020 to 2022Enrolled4ConditionsMarginal Zone Lymphoma, Follicular LymphomaArmsUblituximab, Umbralisib
3 · Its place in the literature

Who cites it

44 citing papers in PubMed, 1 synthesis or guideline pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Article
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  4. Current Status of Molecularly Targeted Therapeutics in Blood Cancers.International journal of molecular sciences · 2025
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  14. Monoclonal Antibodies in the Treatment of Relapsing Multiple Sclerosis: an Overview with Emphasis on Pregnancy, Vaccination, and Risk Management.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    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

13 authors at 9 institutions in 1 country.

Ahmed SawasCenter for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
Charles M FarberCarol G. Simon Cancer Center, Morristown, NJ, USA.
Marshall T SchreederClearview Cancer Institute, Huntsville, AL, USA.
Mazen Y KhalilSt. Bernards Clopton Clinic, Jonesboro, AR, USA.
Daruka MahadevanThe West Clinic, Memphis, TN, USA.
Changchun DengCenter for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
Jennifer E AmengualCenter for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
Petros G NikolinakosUniversity Cancer and Blood Center, Athens, GA, USA.
Jill M KolesarCarbone Comprehensive Cancer Center, University of Wisconsin, Madison, WI, USA.
John G KuhnUniversity of Texas Health Science Center at San Antonio, San Antonio, TX, USA.
Peter SportelliTG Therapeutics Inc., New York, NY, USA.
Hari P MiskinTG Therapeutics Inc., New York, NY, USA.
Owen A O'ConnorCenter for Lymphoid Malignancies, Columbia University Medical Center, New York, NY, USA.
Columbia University Irving Medical Center · USCDG Therapeutics (United States) · USCampbell Clinic · USClearview Cancer Institute · USMorristown Medical Center · USSt. Bernards Clopton Clinic · USThe University of Texas Health Science Center at San Antonio · USUniversity Cancer and Blood Center · USUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This phase 1/2 study evaluated the safety, pharmacokinetic behavior and anti-tumour activity of ublituximab, a unique type I, chimeric, glycoengineered anti-CD20 monoclonal antibody, in rituximab-relapsed or -refractory patients with B-cell non-Hodgkin lymphoma (B-NHL) or chronic lymphocytic leukaemia (CLL). Induction therapy (doses of 450-1200 mg) consisted of 4 weekly infusions in cycle 1 for NHL and 3 weekly infusions in cycles 1 and 2 for CLL. Patients received ublituximab maintenance monthly during cycles 3-5, then once every 3 months for up to 2 years. Enrolled patients with B-NHL (n = 27) and CLL (n = 8) had a median of 3 prior therapies. No dose-limiting toxicities or unexpected adverse events (AEs) occurred. The most common AEs were infusion-related reactions (40%; grade 3/4, 0%); fatigue (37%; grade 3/4, 3%); pyrexia (29%; grade 3/4, 0%); and diarrhoea (26%; grade 3/4, 0%). Common haematological AEs were neutropenia (14%; grade 3/4, 14%) and anaemia (11%; grade 3/4, 6%). The overall response rate for evaluable patients (n = 31) was 45% (13% complete responses, 32% partial responses). Median duration of response and progression-free survival were 9·2 months and 7·7 months, respectively. Ublituximab was well-tolerated and efficacious in a heterogeneous and highly rituximab-pre-treated patient population.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsDose-Response Relationship, DrugFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellLymphoma, Large B-Cell, DiffuseMaleMiddle AgedRituximabAntibodies, MonoclonalAntineoplastic AgentsRituximabublituximabanti-CD20 monoclonal antibodyB-cell lymphomaLFB-R603TG-1101ublituximab

Identifiers

PMID28220479
PMCPMC5412890
OpenAlexW2591427437

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.