Evidence map›Paper›PMID 41526617›Full record

Trial reportLeukemia2026

Randomized phase 3 trial of Ropeginterferon alfa-2b versus surveillance after tyrosine kinase inhibitor discontinuation in chronic myeloid leukemia (ENDURE/CML-IX).

Andreas Burchert, Franck E Nicolini, Philipp le Coutre, Susanne Saussele, Andreas Hochhaus, Evin Tuere, Stephan K Metzelder, Kim Pauck, Holger Garn, Hartmann Raifer and 43 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Leukemia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03117816 (Efficacy and Safety of Pegylated Proline Interferon Alpha 2b), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT03117816 phase3completednot on this map

Efficacy and Safety of Pegylated Proline Interferon Alpha 2b (AOP2014) in Maintaining Deep Molecular Remissions in Patients With Chronic Myeloid Leukemia (CML) Who Discontinue ABL-Kinase Inhibitor Therapy - a Randomized Phase III, Multicenter Trial With Post-study Follow-up

TypeinterventionalSponsorPhilipps University MarburgRan2017 to 2022Enrolled214ConditionsChronic Myeloid Leukemia in RemissionArmsAOP2014 / Pegylated-Proline-interferon alpha-2b, Surveillance
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Review
  2. Road to treatment-free remission in chronic myeloid leukemia.International journal of hematology · 2026
    Review
  3. Review
  4. Article
  5. 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

53 authors.

Andreas BurchertDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany. burchert@staff.uni-marburg.de.ORCID 0000-0002-8411-8844
Franck E NicoliniCentre Hospitalier Lyon Sud, Lyon, Cedex 03, France.
Philipp le CoutreDepartment of Hematology, Oncology and Tumor Immunology, Charité Campus Mitte, Charité-Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.
Susanne SausseleClinic for Hematology and Oncology, University Heidelberg, Mannheim, Germany.ORCID 0000-0003-0357-5785
Andreas HochhausHematology/Oncology, Jena University Hospital, Jena, Germany.ORCID 0000-0003-0626-0834
Evin TuereDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Stephan K MetzelderDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Kim PauckTranslational Inflammation Research Division & Core Facility for Single Cell Multiomics, University Marburg, Marburg, Germany.
Holger GarnTranslational Inflammation Research Division & Core Facility for Single Cell Multiomics, University Marburg, Marburg, Germany.
Hartmann RaiferInstitute of Systems Immunology, University Marburg, Marburg, Germany.
Magdalena HuberInstitute of Systems Immunology, University Marburg, Marburg, Germany.ORCID 0000-0002-2963-0693
Norbert GattermannDepartment of Hematology, Oncology and Clinical Immunology, Heinrich Heine University, Düsseldorf, Germany.
Martina CrysandtDepartment of Hematology, Oncology, Hemostaseology, and Stem Cell Transplantation, Faculty of Medicine, University Hospital RWTH Aachen, Aachen, Germany.
Philippe SchafhausenDepartment of Internal medicine II, University Medical Centre of Hamburg-Eppendorf, Hamburg, Germany.
Matthias BormannKlinikum Bremen Mitte, Bremen, Germany.
Markus P RadsakDepartment of Internal Medicine III, University Medical Center, Johannes Gutenberg-University of Mainz, Mainz, Germany.ORCID 0000-0002-3991-5721
Agnès Guerci-BreslerService d'Hématologie, Centre Hospitalier Universitaire Brabois, Vandoeuvre- lès-, Nancy, France.
Thomas IllmerGroup Practice for Hematology and Oncology, Dresden, Germany.
Maria E GoebelerCCC Trial Office, Würzburg, Germany.
Peter HerhausInternal Medicine III, School of Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.
Lino L TeichmannCenter for Integrated Oncology Aachen-Bonn-Cologne-Düsseldorf (CIO ABCD), Bonn, Germany.
Georg-Nikolaus FrankeDepartment for Hematology, Cell Therapy and Hemostaseology, University of Leipzig Medical Center, Leipzig, Germany.ORCID 0000-0001-8239-002X
Fabian LangDept. of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.
Stefan W KrauseUniklinikum Erlangen, Medicine 5, Erlangen, Germany.ORCID 0000-0002-5259-4651
Robert MöhleDepartment of Hematology and Oncology, University of Tübingen, Tübingen, Germany.
Martine KlausmannPractice for Hematology, Oncology and Gastroeneterology, Aschaffenburg, Germany.
Frank StegelmannDepartment of Internal Medicine III, University Hospital of Ulm, Ulm, Germany.ORCID 0000-0003-2157-476X
Christoph LutzPraxis for Hematology and Oncology, Koblenz, Germany.
Gabriel EtienneGroupe Fi-LMC, Institut Bergonié, Bordeaux, France.
Andrea StoltefußEvangelisches Krankenhaus Hamm, Hamm, Germany.
Joachim R GöthertDepartment of Hematology and Stem Cell Transplantation, West German Cancer center, University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
Thomas ErnstHematology/Oncology, Jena University Hospital, Jena, Germany.ORCID 0000-0003-2147-489X
Maisun Abu-SamraDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Giessen, Germany.
Heinz-Gert HöffkesTumorklinik (Medizinische Onkologie, Palliativmedizin, Hämatologie und Hämostaseologie), Klinikum Fulda, Fulda, Germany.
Andreas NeubauerDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.ORCID 0000-0002-7606-8760
Ying WangDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Paul WeilandDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.ORCID 0000-0003-3175-8271
Clara OttoDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Lea KiesslerDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Theresa WeberDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Lea KroningDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.
Andrea NistGenomics Core Facility, Institute of Molecular Oncology, Member of the German Center for Lung Research (DZL), Philipps University Marburg, Marburg, Germany; Institute of Lung Health (ILH), Justus Liebig University, Giessen, 35392, Germany.
Thorsten StieweGenomics Core Facility, Institute of Molecular Oncology, Member of the German Center for Lung Research (DZL), Philipps University Marburg, Marburg, Germany; Institute of Lung Health (ILH), Justus Liebig University, Giessen, 35392, Germany.ORCID 0000-0003-0134-7826
Rüdiger HehlmannMedizinische Fakultät Mannheim, Universität Heidelberg, Mannheim, Germany, and ELN-Foundation, Weinheim, Germany.
Behnaz AminossadatiMarburg University, Faculty of Medicine, Coordinating Center for Clinical Trials, Marburg, Germany.
Michael WittenbergMarburg University, Faculty of Medicine, Coordinating Center for Clinical Trials, Marburg, Germany.ORCID 0000-0003-4526-1856
Kerstin WintersteinMarburg University, Faculty of Medicine, Coordinating Center for Clinical Trials, Marburg, Germany.
Thomas OellerichDept. of Medicine, Hematology and Oncology, Goethe University Frankfurt, Frankfurt, Germany.ORCID 0000-0001-6570-6125
Marcus LechnerCenter for Synthetic Microbiology, SYNMIKRO, University Marburg, Marburg, Germany.
Markus PfirrmannInstitut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Medizinische Fakultät, Ludwig-Maximilians-Universität, Munich, Germany.
Carmen Schade-BrittingerMarburg University, Faculty of Medicine, Coordinating Center for Clinical Trials, Marburg, Germany.
Paul KlemmCenter for Synthetic Microbiology, SYNMIKRO, University Marburg, Marburg, Germany.ORCID 0000-0002-3609-5713
Christian MichelDepartment of Hematology and Oncology, University Hospital Giessen and Marburg, Marburg University, Marburg, Germany.

Funding

Deutsche Forschungsgemeinschaft (German Research Foundation) GRK2573Deutsche Krebshilfe (German Cancer Aid) 70112020 und 70112841
6 · The paper itself

Abstract

Treatment-free remission (TFR) after discontinuation of ABL tyrosine kinase inhibitors (TKIs) is an important therapeutic goal in chronic myeloid leukemia (CML). Interferon-α (IFN) has been suggested to promote durable TFR. The phase 3 ENDURE trial (NCT03117816; EUDRA-CT 2016-001030-94) prospectively tested this hypothesis in patients with stable deep molecular remission after TKI therapy. A total of 203 patients were randomised 1:1 to receive ropeginterferon alfa-2b (ropeg-IFN; 100 µg subcutaneously every two weeks for 15 months, n = 95) or observation alone (n = 108) after TKI discontinuation. The primary endpoint was molecular relapse-free survival (MRFS), defined as time to loss of major molecular response (MMR) or death. At a median follow-up of 36 months, 25-month MRFS was 56% (95% confidence interval (CI), 45-66) with ropeg-IFN and 59% (95% CI, 49-68) with observation (hazard ratio (HR), 1.02; 95% CI, 0.68-1.55; P = 0.91). Among 83 patients with molecular data after TKI restart, 79 (95%) regained at least MMR, 78 within 12 months (median 3 months, interquartile range: 2-4 months). Ropeg-IFN was well tolerated (median administered dose of 92 µg, range 3-104), and no new safety signals were observed. Ropeg-IFN maintenance did not improve the probability of sustained TFR after TKI discontinuation.

Indexed as

Interferon-alphaInterferon alpha-2Leukemia, Myelogenous, Chronic, BCR-ABL PositivePolyethylene GlycolsProtein Kinase InhibitorsAdultAgedFemaleFollow-Up StudiesHumansMaleMiddle AgedPrognosisRecombinant ProteinsRemission InductionTreatment InterruptionInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsProtein Kinase InhibitorsRecombinant Proteins

Identifiers

PMID41526617
PMCPMC12875868

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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.