Chemo-Free combo shows promise in CLL trial
NCT ID NCT04285567
First seen Nov 01, 2025 · Last updated Jun 23, 2026 · Updated 29 times
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.
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Locations
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AO Santa Maria della Misericordia
Perugia, Umbria, 6132, Italy
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ASST Grande Ospedale Metropolitano Niguarda;Ematologia
Milan, Lombardy, 20162, Italy
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American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817, United States
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Azienda Ospedaliero Universitaria Maggiore della Carità;SCDU Ematologia
Novara, Piedmont, 28100, Italy
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Azienda Ospedaliero Universitaria;Ematologia
Modena, Emilia-Romagna, 41125, Italy
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COMPLEJO HOSPITALARIO DE NAVARRA;Servicio de Hematología
Pamplona, Navarre, 31008, Spain
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Canberra Hospital
Canberra, Australian Capital Territory, 2605, Australia
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Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau;Hématologie et Thérapie Cellulaire
Tours, Indre-et-Loire, 37032, France
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Centre Hospitalier Universitaire de Caen Normandie
Caen, 14000, France
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Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
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Centre Hospitalier Universitaire de Reims - Hôpital Robert Debré;Hématologie Clinique
Reims, 51092, France
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Centre Hospitalier de Pérpignan;hématologie
Perpignan, Languedoc-Roussillon, 66046, France
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Centre Hospitalier intercommunal de Toulon La Seyne sur Mer
Toulon, Provence-Alpes-Côte d'Azur Region, 83100, France
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Clinique Victor Hugo- CCS du Mans
Le Mans, 72000, France
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Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico;U.O.C Ematologia
Milan, Lombardy, 20122, Italy
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Fondazione Policlinico Universitario Agostino Gemelli
Rome, Lazio, 168, Italy
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HENRI MONDOR HOSPITAL;Centre d'investigation clinique
Créteil, Val-de-Marne, 94000, France
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Hopital Claude Huriez - CHU de Lille;service maladies appareil digestif
Lille, Nord, 59037, France
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Hopital Haut Leveque Chu de Bordeaux
Pessac, Aquitaine, 33600, France
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Hospital General Universitario Morales Meseguer;Hematologia y Oncologia médica
Murcia, 30008, Spain
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Hospital Germans Trias i Pujol
Badalona, Barcelona, 8916, Spain
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Hospital Universitari Vall d'Hebron;Hematology
Barcelona, 8035, Spain
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Hospital Universitario La Paz;Hematología
Madrid, 28015, Spain
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Hospital Universitario Virgen del Rocío;Unidad Onco-Hematología Pediátrica
Seville, 41009, Spain
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Hospital Universitario de Toledo
Toledo, 45007, Spain
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Instituto Tumori Giovanni Paolo II;ONCOLOGIA MEDICA
Bari, Apulia, 70124, Italy
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Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
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Medical Center of Aurora
Aurora, Colorado, 80012, United States
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Monash Health;Haematology Research
Clayton, Victoria, 3168, Australia
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Northern Hospital;Oncology and/or Hematology
Melbourne, Victoria, 3076, Australia
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Oncology & Hematology Associates of Southwest Virginia, Inc._Goldschmidt
Roanoke, Virginia, 24014, United States
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Ospedale San Martino;U.O. Clinica Ematologica
Genoa, Liguria, 16132, Italy
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Ospedale Vito Fazzi;U.O. Ematologia IV Piano Polo Oncologico
Lecce, Apulia, 73100, Italy
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Peter MacCallum Cancer Centre;Clinical Haematology
Melbourne, Victoria, 3050, Australia
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Policlinico Umberto I
Rome, Lazio, 161, Italy
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Port Macquarie - Mid North Coast Cancer Institute
Port Macquarie, New South Wales, 2444, Australia
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Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
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Royal North Shore Hospital
St Leonards, New South Wales, 2065, Australia
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University of Tennessee Medical Center;Office of Clinical Trials
Knoxville, Tennessee, 37920, United States
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centre hospitalier lyon sud;Service Hématologie
Pierre-Bénite, Rhône, 69310, France
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.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.