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Chemo-Free combo shows promise in CLL trial

NCT ID NCT04285567

Completed Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested whether a combination of two targeted drugs, venetoclax and obinutuzumab, works better than standard chemotherapy (FCR or BR) in 166 fit patients with previously untreated chronic lymphocytic leukemia (CLL) who lack certain genetic mutations. The main goal was to see how many patients achieved minimal residual disease (MRD) negativity, meaning no detectable leukemia cells. The trial is completed, and results will help determine if this chemo-free option can become a new standard of care.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance
venetoclax and obinutuzumab
What this could lead to
If this combination works better than standard chemo, it could become a new first-line treatment option for fit patients with chronic lymphocytic leukemia, potentially offering deeper remission without chemotherapy.
What could go wrong
This is a completed phase 3 trial, but results may not apply to all CLL patients (e.g., those with del(17p) or TP53 mutations were excluded). Side effects from venetoclax and obinutuzumab can include infusion reactions, low blood counts, and tumor lysis syndrome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)

Contacts and locations

Locations

  • AO Santa Maria della Misericordia

    Perugia, Umbria, 6132, Italy

  • ASST Grande Ospedale Metropolitano Niguarda;Ematologia

    Milan, Lombardy, 20162, Italy

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817, United States

  • Azienda Ospedaliero Universitaria Maggiore della Carità;SCDU Ematologia

    Novara, Piedmont, 28100, Italy

  • Azienda Ospedaliero Universitaria;Ematologia

    Modena, Emilia-Romagna, 41125, Italy

  • COMPLEJO HOSPITALARIO DE NAVARRA;Servicio de Hematología

    Pamplona, Navarre, 31008, Spain

  • Canberra Hospital

    Canberra, Australian Capital Territory, 2605, Australia

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau;Hématologie et Thérapie Cellulaire

    Tours, Indre-et-Loire, 37032, France

  • Centre Hospitalier Universitaire de Caen Normandie

    Caen, 14000, France

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021, France

  • Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré;Hématologie Clinique

    Reims, 51092, France

  • Centre Hospitalier de Pérpignan;hématologie

    Perpignan, Languedoc-Roussillon, 66046, France

  • Centre Hospitalier intercommunal de Toulon La Seyne sur Mer

    Toulon, Provence-Alpes-Côte d'Azur Region, 83100, France

  • Clinique Victor Hugo- CCS du Mans

    Le Mans, 72000, France

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico;U.O.C Ematologia

    Milan, Lombardy, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 168, Italy

  • HENRI MONDOR HOSPITAL;Centre d'investigation clinique

    Créteil, Val-de-Marne, 94000, France

  • Hopital Claude Huriez - CHU de Lille;service maladies appareil digestif

    Lille, Nord, 59037, France

  • Hopital Haut Leveque Chu de Bordeaux

    Pessac, Aquitaine, 33600, France

  • Hospital General Universitario Morales Meseguer;Hematologia y Oncologia médica

    Murcia, 30008, Spain

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 8916, Spain

  • Hospital Universitari Vall d'Hebron;Hematology

    Barcelona, 8035, Spain

  • Hospital Universitario La Paz;Hematología

    Madrid, 28015, Spain

  • Hospital Universitario Virgen del Rocío;Unidad Onco-Hematología Pediátrica

    Seville, 41009, Spain

  • Hospital Universitario de Toledo

    Toledo, 45007, Spain

  • Instituto Tumori Giovanni Paolo II;ONCOLOGIA MEDICA

    Bari, Apulia, 70124, Italy

  • Liverpool Hospital

    Liverpool, New South Wales, 2170, Australia

  • Medical Center of Aurora

    Aurora, Colorado, 80012, United States

  • Monash Health;Haematology Research

    Clayton, Victoria, 3168, Australia

  • Northern Hospital;Oncology and/or Hematology

    Melbourne, Victoria, 3076, Australia

  • Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt

    Roanoke, Virginia, 24014, United States

  • Ospedale San Martino;U.O. Clinica Ematologica

    Genoa, Liguria, 16132, Italy

  • Ospedale Vito Fazzi;U.O. Ematologia IV Piano Polo Oncologico

    Lecce, Apulia, 73100, Italy

  • Peter MacCallum Cancer Centre;Clinical Haematology

    Melbourne, Victoria, 3050, Australia

  • Policlinico Umberto I

    Rome, Lazio, 161, Italy

  • Port Macquarie - Mid North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444, Australia

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000, Australia

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065, Australia

  • University of Tennessee Medical Center;Office of Clinical Trials

    Knoxville, Tennessee, 37920, United States

  • centre hospitalier lyon sud;Service Hématologie

    Pierre-Bénite, Rhône, 69310, France

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