Evidence map›Paper›PMID 27982425›Full record

Trial reportBritish journal of haematology2017

Ublituximab (TG-1101), a novel glycoengineered anti-CD20 antibody, in combination with ibrutinib is safe and highly active in patients with relapsed and/or refractory chronic lymphocytic leukaemia: results of a phase 2 trial.

Jeff P Sharman, Charles M Farber, Daruka Mahadevan, Marshall T Schreeder, Heather D Brooks, Kathryn S Kolibaba, Suzanne Fanning, Leonard Klein, Daniel R Greenwald, Peter Sportelli and 3 more

Open access · hybridAbstract readClinical Trial, Phase II
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. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
5.2field-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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. The Present and Future of Monoclonal Antibody Therapies for Multiple Sclerosis.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2025
    Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Monoclonal Antibody Therapies Beyond Complement for NMOSD and MOGAD.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  12. 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
  13. Review
  14. Review
  15. Review
  16. Review
  17. NK Cells in Chronic Lymphocytic Leukemia and Their Therapeutic Implications.International journal of molecular sciences · 2021
    Review
  18. Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 1 country.

Jeff P SharmanWillamette Valley Cancer Institute, Springfield, OR, USA.
Charles M FarberCarol G. Simon Cancer Center, Morristown, NJ, USA.
Daruka MahadevanWest Cancer Center/University of Tennessee Health Science Center, Memphis, TN, USA.
Marshall T SchreederClearview Cancer Institute, Huntsville, AL, USA.
Heather D BrooksUS Oncology Research, Morristown, NJ, USA.
Kathryn S KolibabaUS Oncology Research, Morristown, NJ, USA.
Suzanne FanningUS Oncology Research, Morristown, NJ, USA.
Leonard KleinUS Oncology Research, Morristown, NJ, USA.
Daniel R GreenwaldUS Oncology Research, Morristown, NJ, USA.
Peter SportelliTG Therapeutics, Inc., New York, NY, USA.
Hari P MiskinTG Therapeutics, Inc., New York, NY, USA.
Michael S WeissTG Therapeutics, Inc., New York, NY, USA.
John M BurkeUS Oncology Research, Morristown, NJ, USA.
Morristown Medical Center · USAtlantic Health System · USCDG Therapeutics (United States) · USClearview Cancer Institute · USThe US Oncology Network · USWest Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ibrutinib is effective in patients with chronic lymphocytic leukaemia (CLL); however, treatment resistance remains a problem. Ublituximab is a novel, glycoengineered anti-CD20 monoclonal antibody with single-agent activity in relapsed CLL. We report the results of a phase 2 study evaluating combination therapy with ibrutinib and ublituximab in patients with relapsed or refractory CLL. Patients received ibrutinib 420 mg once daily. Ublituximab was administered on days 1, 8 and 15 of cycle 1 followed by day 1 of cycles 2-6. Response assessments were completed at cycles 3 and 6; patients then continued on ibrutinib monotherapy per standard of care. Forty-one of 45 enrolled patients were evaluable for efficacy. Safety was consistent with prior experience for each drug, with infusion reactions the most prevalent adverse event. Combination therapy resulted in an overall response rate (ORR) of 88% at 6 months. In the 20 patients with high-risk features (17p or 11q deletions or TP53 mutation) and evaluable for efficacy, the ORR was 95%, with three patients (15%) achieving negative minimal residual disease. Median time to response was 8 weeks. Ublituximab in combination with ibrutinib resulted in rapid and high response rates. The long-term clinical benefit of ublituximab will be defined by an ongoing phase 3 trial (NCT 02301156).

Indexed as

AdenineAdultAgedAged, 80 and overAntibodies, MonoclonalAntigens, CD20Antineoplastic Combined Chemotherapy ProtocolsFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesProtein EngineeringPyrazolesPyrimidinesAdenineAntibodies, MonoclonalAntigens, CD20ibrutinibPiperidinesPyrazolesPyrimidinesublituximab17-p deletionchronic lymphocytic leukaemiahigh-riskibrutinibublituximab

Identifiers

PMID27982425
PMCPMC5299538
OpenAlexW2565099910

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.