Evidence map›Paper›PMID 38438627›Full record

ArticleAnnals of hematology2024

ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options.

Jean-Jacques Kiladjian, Francisca Ferrer Marin, Haifa Kathrin Al-Ali, Alberto Alvarez-Larrán, Eloise Beggiato, Maria Bieniaszewska, Massimo Breccia, Veronika Buxhofer-Ausch, Olga Cerna, Ana-Manuela Crisan and 31 more

Open access · hybridAbstract readClinical Trial Protocol
In one paragraph

Article in Annals of hematology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
4.8field-weighted citation impact, top 5% 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

11 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
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  6. Article
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  8. Pegylated interferon: the who, why, and how.Hematology. American Society of Hematology. Education Program · 2024
    Review
  9. Article
  10. Article
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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

41 authors at 20 institutions in 10 countries.

Jean-Jacques KiladjianCIC 1427, Inserm, Université Paris Cité, 75010, Paris, France. jean-jacques.kiladjian@aphp.fr.
Francisca Ferrer MarinMorales Meseguer University General Hospital, Regional Center of Blood Donation. CIBERER. UCAM. IMIB-Murcia, Murcia, Spain.
Haifa Kathrin Al-Ali *University Hospital Halle (Saale), Krukenberg Cancer Center Halle, Halle, Germany.
Alberto Alvarez-Larrán *Department of Hematology, Hospital Clínic of Barcelona, Barcelona, Spain.
Eloise Beggiato *University Hospital City of Health and Science of Turin - Hospital Molinette, Complex Structure of Hematology, Torino, Italy.
Maria Bieniaszewska *Medical University of Gdańsk, Gdańsk, Poland.
Massimo Breccia *Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.
Veronika Buxhofer-Ausch *Department of Internal Medicine I for Hematology with Stem Cell Transplantation, Hemostaseology and Medical Oncology, Ordensklinikum Linz Elisabethinen, Johannes Kepler University Linz, Linz, Austria.
Olga Cerna *Clinic of Internal Hematology, University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Ana-Manuela Crisan *Fundeni Clinical Institute, Center for Hematology and Bone Marrow Transplantation, București, Romania.
Catalin Doru Danaila *Department of Clinical Hematology, Regional Institute of Oncology, Iasi, Romania.
Valerio De Stefano *Fondazione Policlinico Gemelli IRCCS, Section of Hematology, Catholic University, Rome, Italy.
Konstanze Döhner *Department of Internal Medicine III, University Hospital Ulm, Ulm, Germany.
Victoria EmpsonAOP Health, Vienna, Austria.
Joanna Gora-Tybor *Department of Hematooncology, Copernicus Memorial Hospital, Lodz, Poland.
Martin Griesshammer *Department of Oncology and Hematology, Ruhr University Bochum, Johannes Wesling Hospital Minden, Minden, Germany.
Sebastian Grosicki *Medical University of Silesia, Katowice, Poland.
Paola Guglielmelli *Department of Hematology, Careggi University Hospital, Florence, Italy.
Valentin García-Gutierrez *Hospital Universitario Ramón y Cajal, Madrid (IRYCIS), Madrid, Spain.
Florian H Heidel *Clinic for Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School (MHH), Hannover, Germany.
Arpád Illés *Faculty of Medicine, Department of Internal Medicine, Division of Hematology, University of Debrecen, Debrecen, Hungary.
Ciprian Tomuleasa *Ion Chiricuta Institute of Oncology, Hematology Department and Medfuture Research Center for Advanced Medicine, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Chloe James *University Bordeaux, INSERM, BMC, U1034, F-33600, Pessac, France.
Steffen Koschmieder *Faculty of Medicine, Department of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation (Medical Clinic IV), RWTH Aachen University, Aachen, Germany.
Maria-Theresa Krauth *Department of Internal Medicine I, Clinical Department of Hematology and Hemostaseology, Medical University of Vienna, Vienna, Austria.
Kurt KrejcyAOP Health, Vienna, Austria.
Mihaela-Cornelia Lazaroiu *Department of Hematology, Policlinica de Diagnostic Rapid Brasov, Brasov, Romania.
Jiri Mayer *University Hospital Brno, Department of Internal Medicine, Hematology and Oncology, Masaryk University, Brno, Czech Republic.
Zsolt György Nagy *Department of Internal Medicine and Hematology, Division of Hematology, Semmelweis University, Budapest, Hungary.
Franck-Emmanuel Nicolini *Centre Léon Bérard, Lyon, France.
Francesca Palandri *IRCCS Azienda Ospedaliero-Universitaria di Bologna and Istituto di Ematologia Seràgnoli, Bologna, Italy.
Vassiliki Pappa *University General Hospital Attikon, Athens, Greece.
Andreas Johannes Reiter *Medical Clinic III, Hematology and Internistic Oncology, University Hospital Mannheim, Mannheim, Germany.
Tomasz Sacha *Department of Hematology, Jagiellonian University Hospital, Kraków, Poland.
Stefanie SchlagerAOP Health, Vienna, Austria.
Stefan Schmidt *Department of Internal Medicine V (Hematology and Oncology), Medical University Innsbruck, Innsbruck, Austria.
Evangelos Terpos *Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Martin UngerAOP Health, Vienna, Austria.
Albert Wölfler *Department of Internal Medicine, Clinical Divison of Hematology, Medical University Graz, Graz, Austria.
Blanca Xicoy Cirici *Institut Català d' Oncologia- Hospital Germans Trias i Pujol, Josep Carreras Leukemia Research Institute, Universitat Autònoma de Barcelona, Barcelona, Spain.
Christoph KladeAOP Health, Vienna, Austria.
Agostino Gemelli University Polyclinic · ITAzienda Ospedaliero-Universitaria Careggi · ITCentre Léon Bérard · FRCopernicus Memorial Hospital · PLGdańsk Medical University · PLHeidelberg University · DEHospital Clínic de Barcelona · ESHospital General Universitario Morales Meseguer · ESInnsbruck Medical University · ATInserm · FRInstitutul Clinic Fundeni · ROInstitutul Regional de Oncologie · ROIstituto di Ematologia di Bologna · ITIuliu Hațieganu University of Medicine and Pharmacy · ROJagiellonian University · PLJohannes Kepler University of Linz · ATJohannes Wesling Klinikum Minden · DEMasaryk University · CZMedical University of Graz · ATMedical University of Silesia · PL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Interferon-based therapies, such as ropeginterferon alfa-2b have emerged as promising disease-modifying agents for myeloproliferative neoplasms (MPNs), including essential thrombocythemia (ET). Current ET treatments aim to normalize hematological parameters and reduce the thrombotic risk, but they do not modify the natural history of the disease and hence, have no impact on disease progression. Ropeginterferon alfa-2b (trade name BESREMi®), a novel, monopegylated interferon alfa-2b with an extended administration interval, has demonstrated a robust and sustained efficacy in polycythemia vera (PV) patients. Given the similarities in disease pathophysiology and treatment goals, ropeginterferon alfa-2b holds promise as a treatment option for ET. The ROP-ET trial is a prospective, multicenter, single-arm phase III study that includes patients with ET who are intolerant or resistant to, and/or are ineligible for current therapies, such as hydroxyurea (HU), anagrelide (ANA), busulfan (BUS) and pipobroman, leaving these patients with limited treatment options. The primary endpoint is a composite response of hematologic parameters and disease-related symptoms, according to modified European LeukemiaNet (ELN) criteria. Secondary endpoints include improvements in symptoms and quality of life, molecular response and the safety profile of ropeginterferon alfa-2b. Over a 3-year period the trial assesses longer term outcomes, particularly the effects on allele burden and clinical outcomes, such as disease-related symptoms, vascular events and disease progression. No prospective clinical trial data exist for ropeginterferon alfa-2b in the planned ET study population and this study will provide new findings that may contribute to advancing the treatment landscape for ET patients with limited alternatives.

trial registrationEU Clinical Trials Register; EudraCT, 2023-505160-12-00; Registered on October 30, 2023.

Indexed as

Interferon-alphaInterferon alpha-2Polyethylene GlycolsRecombinant ProteinsThrombocythemia, EssentialAdultAgedClinical Trials, Phase III as TopicFemaleHumansMaleMiddle AgedMulticenter Studies as TopicProspective StudiesTreatment OutcomeInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsDisease modificationEssential thrombocythemia (ET)Myeloproliferative neoplasms (MPNs)Phase IIIRopeginterferon alfa-2bROP-ET

Identifiers

PMID38438627
PMCPMC11224110
OpenAlexW4392383194

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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.