Measurable residual disease-guided combination of ibrutinib plus venetoclax versus FCR in previously untreated patients with intermediate-risk chronic lymphocytic leukaemia: a phase 2, randomised trial (ERADIC) from the FILO group

Sep 29, 2026

Chronic lymphocytic leukaemia (CLL) with intermediate-risk features defined by unmutated IGHV and/or 11q deletion and/or complex karyotype (without TP53 alteration) has an unclear best first-line strategy. In the ERADIC phase 2 randomised trial, a measurable residual disease (MRD)-guided fixed-duration ibrutinib-venetoclax regimen was compared with fludarabine-cyclophosphamide-rituximab (FCR). Missing bone marrow MRD data at month 27 prevented primary outcome feasibility, so reported results reflect secondary exploratory endpoints.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Background

Methods

Findings

Interpretation

Articles Measurable residual disease-guided combination of ibrutinib plus venetoclax versus FCR in previously untreated patients with intermediate-risk chronic lymphocytic leukaemia: a phase 2, randomised trial (ERADIC) from the FILO group Anne Quinquenel,a Rémi Letestu,b Magali Le Garff-Tavernier,c Stéphane Morisset,d Fabien Subtil,e Thérèse Aurran,f Kamel Laribi,g Florence Cymbalista,h Vincent Lévy,i Laurence Simon,j Damien Roos-Weil,k Véronique Leblond,k Marie-Sarah Dilhuydy,l Cécile Tomowiak,m Caroline Dartigeas,n Romain Guièze,o Olivier Tournilhac,o Emmanuelle Ferrant,p Sophie de Guibert,q Pierre Feugier,r Fatiha Merabet,s Stéphane Leprêtre,t Philippe Carassou,u Julie Gay,v Bénédicte Hivert,w Luc-Matthieu Fornecker,x Jehan Dupuis,y Lysiane Molina,z Bruno Villemagne,aa Guillaume Cartron,ab Bernard Drenou,ac Beatrice Mahé,ad Omar Benbrahim,ae Xavier Cahu,af Christelle Portois,ag Loïc Ysebaert,ah Florence Nguyen-Khac,c Abdelmalek Dahmani,b Claire Quiney,c Valérie Rouillé,ai Alain Delmer,a and Anne-Sophie Michalletaj,∗ aHaematology Clinic, Reims University Hospital, Reims, France bHaematology Biology, Avicenne Hospital, APHP, Bobigny, France cHaematology Biology, Pitié Salpêtrière Hospital, APHP, Paris, France dStatistics, Centre Léon Bérard, Lyon, France eBiostatistics, Hospices Civils de Lyon, Lyon, France fInstitut Paoli Calmettes, Marseilles, France gHaematology Clinic, Du Mans Hospital, Le Mans, France hHaematology Department, Avicenne Hospital, APHP, Bobigny, France iClinical Research, Avicenne Hospital, APHP, Bobigny, France jCH Sud Francilien, Corbeil-Essonnes, France kHaematology Clinic, Hospital Pitié-Salpêtrière, Sorbonne Université, APHP, Paris, France lHaematology Clinic, Bordeaux University Hospital, Pessac, France mHaematology Clinic, Poitiers University Hospital, Poitiers, France nHaematology Clinic, Tours University Hospital, Tours, France oHaematology Clinic, Clermont-Ferrand University Hospital, Clermont-Ferrand, France pHaematology Clinic, CH Lyon Sud, Oullins Pierre Bénite, France qHaematology Clinic, Rennes University Hospital, Rennes, France rHaematology Clinic, Nancy University Hospital, Vandoeuvre les Nancy, FrancesHaematology Clinic, CH Versailles, Le Chesnay, France tHaematology Clinic, Centre Henri Becquerel, Rouen, France uHaematology Clinic, CH Metz-Thionville, Metz, France vHaematology Clinic, CH de la Côte Basque, Bayonne, France wHaematology Clinic, Groupement des Hopitaux Intitut Catholique de Lille, Lille, France xHaematology Clinic, ICANS, Strasbourg, France yHenri Mondor Hospital, Créteil, France zHaematology Clinic, Grenoble University Hospital, La Tronche, France aaHaematology Clinic, CH La Roche sur Yon, La Roche-sur-Yon, France abHaematology Clinic, Montpellier University Hospital, Montpellier, FranceacHaematology Clinic, CH Mulhouse, Mulhouse, France adHaematology Clinic, Nantes University Hospital, Nantes, France aeHaematology Clinic, Hopital La Source-CHR Orléans, Orléans, France afHaematology Clinic, Les Hopitaux Rennais, Cesson Sévigné, France agHaematology Clinic, CH Saint Etienne, France ahInstitut Universitaire du Cancer Toulouse-Oncopole, Toulouse, France aiClinical Research, Montpellier University Hospital, Montpellier, France ajHaematology Clinic, Centre Léon Bérard, Lyon, France *Corresponding author. Haematology Clinic, Centre Léon Bérard, 28 rue Laennec, 69008 Lyon, France. E-mail address: [anne-sophie.michallet@lyon.unicancer.fr](anne-sophie.michallet@lyon.unicancer.fr) (A.-S. Michallet). [www.thelancet.com Vol](www.thelancet.com Vol) 91 January, 2026 1 Articles eClinicalMedicine 2026;91: 103707 Published Online xxx [https://doi.org/10](https://doi.org/10) . 1016/j.eclinm.2025 . 103707 Summary Background For chronic lymphocytic leukaemia (CLL) and intermediate risk factors (unmutated IGHV and/or 11q deletion and/or complex karyotype; no TP53 alteration), the best first-line treatment is unclear. We compared an MRD-guide

FAQs

What patient group was enrolled in the ERADIC phase 2 trial?

Previously untreated, fit adults with intermediate-risk CLL were recruited across 35 French hospitals.

How were the two treatment arms designed in the trial?

Participants were randomised 1:1 to FCR for 6 cycles or to ibrutinib plus venetoclax with duration determined by bone marrow MRD level.

Why was the primary outcome analysis not performed?

A high amount of missing bone marrow MRD data at month 27, including imbalance between arms, made the primary statistical analysis not feasible.

Sep 29, 2026

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