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Chemo-Free combo shows promise in CLL trial

NCT ID NCT04285567

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

166 people

The number who actually took part.

Started

May 2020

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ability to comply with the study protocol, in the investigator's judgment * Aged 18 years or older * Have previously untreated documented Chronic Lymphocytic Leukemia (CLL) according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * CLL requiring treatment according to the iwCLL criteria * Cumulative Illness Rating Scale (CIRS) score ≤ 6 and creatinine clearance (CrCl) ≥ 70 mL/min * Hematology values within the following limits, unless cytopenia is caused by the underlying disease (i.e., no evidence of additional bone marrow (BM) dysfunction; e.g., myelodysplastic syndrome, hypoplastic BM): * Absolute neutrophil count ≥ 1.0 x 109/L, unless there is BM involvement * Platelet count ≥ 75 x 109/L and more than 7 days since last transfusion, or ≥ 30 x 109/L if there is BM involvement * Adequate liver function as indicated by a total bilirubin, aspartate aminotransferase, and Alanine transaminase ≤ 2 times the institutional upper limit of normal (ULN) value, unless directly attributable to the participant's CLL * Life expectancy \>6 months * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception and agreement to refrain from donating eggs * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agreement to refrain from donating sperm Exclusion Criteria: * Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) * Participants with Small Lymphocyclic Lymphoma (SLL) only * Known central nervous system involvement * Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) * Detected del(17p) or TP53 mutation (valid test within 6-months from screening is required for randomisation) * An individual organ/system impairment score of 4 as assessed by the Cumulative Illness Rating Scale (CIRS) definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system * Participants with uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia * History of prior malignancy * Participants with infections requiring IV treatment (Grade 3 or 4) within the last 8 weeks prior to enrollment * Evidence of other clinically significant uncontrolled conditions including but not limited to active or uncontrolled systemic infection (e.g., viral, bacterial, or fungal) * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * Hypersensitivity to fludarabine, bendamustine, cyclophosphamide, rituximab, obinutuzumab, or venetoclax or to any of the excipients (e.g., trehalose) * Pregnant women and nursing mothers * Vaccination with a live vaccine ≤ 28 days prior to randomization * Prisoners or participants who are institutionalized by regulatory or court order or persons who are in dependence to the Sponsor or an investigator * History of illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment * Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) * Positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) * Participants with known infection with HIV or Human T-Cell Leukemia Virus 1 (HTLV-1) * Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study * Received any of the following agents within 28 days prior to the first dose of study treatment: * Immunotherapy * Radiotherapy * Hormone therapy * Any therapies intended for the treatment of lymphoma/leukemia whether approved or experimental * Participants who have received the following agents: * Strong and moderate CYP3A inhibitors/inducers within 7 days prior to the initiation of study treatment * Steroid therapy for anti-neoplastic intent with the exception of inhaled steroids for asthma, topical steroids, or replacement/stress corticosteroids within 7 days prior to the first dose of study drug administration * Consumed grapefruit, grapefruit products, Seville oranges(including marmalade containing Seville oranges), or star fruit within 3 days prior to the first dose of study drug and throughout venetoclax administration * Inability to swallow a large number of tablets.

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.