Evidence map›Paper›PMID 32762271›Full record

Trial reportLeukemia & lymphoma2020

Final 5-year findings from the phase 3 HELIOS study of ibrutinib plus bendamustine and rituximab in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Graeme A M Fraser, Asher Chanan-Khan, Fatih Demirkan, Rodrigo Santucci Silva, Sebastian Grosicki, Ann Janssens, Jiri Mayer, Nancy L Bartlett, Marie-Sarah Dilhuydy, Javier Loscertales and 16 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Leukemia & lymphoma, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01611090 (Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase), which is not on this map. Cited by 29 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 4 pooled it
3.3field-weighted citation impact, top 7% 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.

NCT01611090 phase3completednot on this map

Randomized, Double-blind, Placebo-controlled Phase 3 Study of Ibrutinib, a Bruton's Tyrosine Kinase (BTK) Inhibitor, in Combination With Bendamustine and Rituximab (BR) in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

TypeinterventionalSponsorJanssen Research & Development, LLCRan2012 to 2019Enrolled578ConditionsChronic Lymphocytic Leukemia, Small Lymphocytic LymphomaArmsIbrutinib, Bendamustine hydrochloride, Rituximab, Placebo
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 4 syntheses or guidelines pooled it, 43 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Article
  7. Article
  8. The role of MRD monitoring and options for CLL management in relapsed/refractory disease.Hematology. American Society of Hematology. Education Program · 2025
    Review
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  11. Review
  12. Article
  13. Article
  14. Article
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  16. Review
  17. B-cell Receptor Pathway Mutations Are Infrequent in Patients with Chronic Lymphocytic Leukemia on Continuous Ibrutinib Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2023
    Article
  18. Review
  19. Review
  20. Article
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

26 authors at 19 institutions in 13 countries.

Graeme A M FraserJuravinski Cancer Centre, McMaster University, Hamilton, Canada.
Asher Chanan-KhanDivision of Hematology, Mayo Clinic Cancer Center, Jacksonville, FL, USA.
Fatih DemirkanDivision of Hematology, Dokuz Eylul University, Izmir, Turkey.
Rodrigo Santucci SilvaIEP São Lucas/Hemomed Oncologia e Hematologia, São Paulo, Brazil.
Sebastian GrosickiDepartment of Hematology and Cancer Prevention, School of Public Health, Silesian Medical University, Katowice, Poland.
Ann JanssensUniversitaire Ziekenhuizen Leuven, Leuven, Belgium.
Jiri MayerDepartment of Internal Medicine, Hematology and Oncology, University Hospital Brno, Jihlavska, Brno, Czech Republic.
Nancy L BartlettSiteman Cancer Center, Washington University School of Medicine, St. Louis, MO, USA.ORCID 0000-0001-8470-394X
Marie-Sarah DilhuydyHopital Haut Leveque, Bordeaux, France.
Javier LoscertalesHematology Department, Hospital Universitario La Princesa, IIS-IP, Madrid, Spain.
Abraham AvigdorDivision of Hematology and Bone Marrow Transplantation, Chaim Sheba Medical Center, Tel-Hashomer and Sackler School of Medicine, University of Tel-Aviv, Tel-Aviv, Israel.
Simon RuleDepartment of Haematology, University of Plymouth Medical School, Plymouth, UK.ORCID 0000-0001-8937-6351
Olga SamoilovaNizhny Novogorod Regional Clinical Hospital, Nizhny Novogorod, Russia.
Miguel A PavlovskyDepartment of Hematology, Fundaleu, Buenos Aires, Argentina.
Andre GoyJohn Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.
Anthony MatoMemorial Sloan-Kettering Cancer Center, NY, USA.
Michael HallekDepartment I of Internal Medicine and German CLL Study Group, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.
Mariya SalmanJanssen Research & Development, Raritan, NJ, USA.
Monelle TamegnonJanssen Research & Development, Raritan, NJ, USA.
Steven SunJanssen Research & Development, Raritan, NJ, USA.
Anne ConnorJanssen Research & Development, Spring House, PA, USA.
Kerri NottageJanssen Research & Development, Raritan, NJ, USA.
Natasha SchuierJanssen-Cilag, Neuss, Germany.
Sriram BalasubramanianJanssen Research & Development, Spring House, PA, USA.
Angela HowesJanssen Research & Development, High Wycombe, UK.
Paula CramerDepartment I of Internal Medicine and German CLL Study Group, University of Cologne, Faculty of Medicine and University Hospital of Cologne, Cologne, Germany.
Janssen (United States) · USUniversity of Cologne · DEDokuz Eylül University · TRFundación para la Investigación, Docencia y Prevención del Cáncer · ARHackensack University Medical Center · USHôpital Cardiologique du Haut-Lévêque · FRHospital Universitario de La Princesa · ESJanssen (Germany) · DEJanssen (United Kingdom) · GBJuravinski Cancer Centre · CAMedical University of Silesia · PLMemorial Sloan Kettering Cancer Center · USNizhny Novgorod Regional Clinical Hospital named after Semashko · RUSheba Medical Center · ILUniversitair Ziekenhuis Leuven · BEUniversity Hospital Brno · CZUniversity of Plymouth · GBWashington University in St. Louis · USWinnMed · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

We report final analysis outcomes from the phase 3 HELIOS study (NCT01611090). Patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma without deletion 17p (

Indexed as

Leukemia, Lymphocytic, Chronic, B-CellAdenineAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideHumansPiperidinesRituximabAdenineBendamustine HydrochlorideibrutinibPiperidinesRituximab5-year follow-upHELIOS phase 3 trialIbrutiniboverall survivalrelapsed chronic lymphocytic leukemia

Identifiers

PMID32762271
PMCPMC9094431
OpenAlexW3048067521

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.