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New drug combo shows promise for leukemia patients with other health problems

NCT ID NCT02242942

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 trial tested a combination of obinutuzumab and venetoclax against obinutuzumab plus chlorambucil in 445 people with untreated chronic lymphocytic leukemia (CLL) who also had other medical conditions. The goal was to see which combo worked better at delaying disease progression. Treatment lasted about a year, with follow-up up to 9 years.

What this could mean

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

Active substance
obinutuzumab and venetoclax
What this could lead to
If successful, this combination could offer a more effective, chemotherapy-free option for people with chronic lymphocytic leukemia who have other health issues.
What could go wrong
This is a Phase 3 trial, but results may not apply to all patients. The combination may cause side effects like infections or low blood counts, and long-term benefits are still being studied.

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

445 people

The number who actually took part.

Started

Dec 2014

Finished

Aug 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: * Documented previously untreated CLL according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria * CLL requiring treatment according to IWCLL criteria * Total Cumulative Illness Rating Scale (CIRS score) greater than (\>) 6 * Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL * Adequate liver function * Life expectancy \> 6 months * Agreement to use highly effective contraceptive methods per protocol Exclusion Criteria: * Transformation of CLL to aggressive Non-Hodgkin's lymphoma (Richter's transformation or pro-lymphocytic leukemia) * Known central nervous system involvement * Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML) * An individual organ/ system impairment score of 4 as assessed by the 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 * Inadequate renal function * History of prior malignancy, except for conditions as listed in the protocol if participants have recovered from the acute side effects incurred as a result of previous therapy * Use of investigational agents or concurrent anti-cancer treatment within the last 4 weeks of registration * Participants with active bacterial, viral, or fungal infection requiring systemic treatment within the last two months prior to registration * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products * Hypersensitivity to chlorambucil, obinutuzumab, or venetoclax or to any of the excipients * Pregnant women and nursing mothers * Positive test results for chronic hepatitis B virus (HBV) infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) or positive test result for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing) * Participants with known infection with human immunodeficiency virus (HIV) or human T-cell leukemia virus-1 (HTLV-1) * Requires the use of warfarin, marcumar, or phenprocoumon * Received agents known to be strong and moderate Cytochrome P450 3A inhibitors or inducers within 7 days prior to the first dose of study drug

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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.

Lymphocytic leukemia, chronic

Contacts and locations

Locations

  • AOU Città della Salute e della Scienza di Torino - Presidio Le Molinette

    Torino, Lazio, 10126, Italy

  • Arcispedale S. Anna

    Ferrara, Emilia-Romagna, 44100, Italy

  • Arthur J.E. Child Comprehensive Cancer Center

    Calgary, Alberta, T2N 4N2, Canada

  • Ashford Cancer Centre Research

    Ashford, South Australia, 5035, Australia

  • Az. Osp. S. Maria

    Terni, Umbria, 05100, Italy

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307, Germany

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS, United Kingdom

  • Boston Pilgrim Hospital

    Boston,Lincolnshire, PE21 9QS, United Kingdom

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098, Germany

  • CH de Toulon Hôpital Sainte Musse

    Toulon, 83056, France

  • CHU de Grenoble

    Grenoble, 38043, France

  • Canterbury Health Laboratories

    Christchurch, 8011, New Zealand

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Jean Bernard

    Le Mans, 72000, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Charite - Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Charite - Universitätsmedizin Berlin

    Berlin, 13353, Germany

  • City of Hope

    Duarte, California, 91010, United States

  • Clinical MSCh No1

    Perm, 614077, Russia

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Complejo Hospitalario de Toledo- H. Virgen de la Salud

    Toledo, 45004, Spain

  • Dunedin Hospital

    Dunedin, New Zealand

  • Fundeni Clinical Inst.

    Bucharest, 022328, Romania

  • Hanusch-Krankenhaus

    Vienna, 1140, Austria

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689, United States

  • Herlev Hospital

    Herlev, 2730, Denmark

  • Hopital Henri Mondor

    Créteil, 94000, France

  • Hopital Hotel Dieu Et Hme

    Nantes, 44093, France

  • Hopital Pontchaillou

    Rennes, 35033, France

  • Hopital Saint Louis

    Paris, 75475, France

  • Hospital Arnau de Vilanova (Valencia) Servicio de Hematologia

    Valencia, 46015, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital Clínic i Provincial

    Barcelona, 08036, Spain

  • Hospital General de Culiacan

    Culiacán, Sinaloa, 80230, Mexico

  • Hospital Italiano

    Buenos Aires, C1181ACH, Argentina

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Univ. 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Saint Eloi

    Montpellier, 34295, France

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426, United States

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Institut Gustave Roussy - Hematologie

    Villejuif, 94805, France

  • Institut d'Hématologie de Basse Normandie

    Caen, 14000, France

  • Instituto de Ensino e Pesquisa Sao Lucas - IEP

    São Paulo, São Paulo, 01236-030, Brazil

  • Institutul Regional de Oncologie Iasi

    Iași, 700483, Romania

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Joe Arrington Cancer Center

    Lubbock, Texas, 79410, United States

  • Klinik Esslingen

    Esslingen am Neckar, 73730, Germany

  • Kliniken Maria Hilf GmbH Innere Medizin I

    Mönchengladbach, 41063, Germany

  • Klinikum Frankfurt/Oder

    Frankfurt (Oder), 15236, Germany

  • Klinikum Schwäbisch Gmünd

    Mutlangen, 73557, Germany

  • Klinikum der Universität München, Campus Großhadern

    München, 83177, Germany

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675, Germany

  • Krankenhaus Barmherzige Bruder Regensburg

    Regensburg, 93049, Germany

  • Lincoln County Hospital

    Lincoln, LN2 5QY, United Kingdom

  • Liverpool Hospital

    Liverpool BC, New South Wales, 1871, Australia

  • Luzerner Kantonsspital, Hämatologie

    Lucerne, 6000, Switzerland

  • MHAT Hristo Botev

    Vratsa, 3000, Bulgaria

  • Marienhospital

    Stuttgart, 70199, Germany

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Midcentral District Health Board

    Palmerston North, 4442, New Zealand

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9497, United States

  • Monash Medical Centre

    Melbourne, Victoria, 3168, Australia

  • München Klinik Schwabing

    München, 80804, Germany

  • North Estonia medical Centre

    Tallinn, 13419, Estonia

  • Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Ospedale dell' Angelo

    Venezia Mestre, Veneto, 30174, Italy

  • Penza Regional Oncology Dispensary

    Penza, 440071, Russia

  • Praxisklinik für Hämatologie und Onkologie Koblenz

    Koblenz, 56068, Germany

  • Princess Alexandra Hospital Woolloongabba

    Woolloongabba, Queensland, 4102, Australia

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Regional Clinical Hospital N.A. Semashko

    Nizhny Novgorod, Niznij Novgorod, 603126, Russia

  • Republican Clinical Oncologic Dispensary of Republic Of Tatarstan

    Kazan', Tatarstan Republic, 420029, Russia

  • Rigshospitalet

    København Ø, 2100, Denmark

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376, Germany

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • SBEI of HPE ?Bashkir State Medical University? of MoH RF

    Ufa, Bashkortostan Republic, 450000, Russia

  • Samodzielny Public Zaklad

    Chorzów, 41-500, Poland

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroc?awiu

    Wroclaw, 5036, Poland

  • Sjaellands Universitetshospital, Roskilde

    Roskilde, 4000, Denmark

  • Spitalul Clinic Judetean de Urgenta Targu-Mures

    Târgu Mureş, 540136, Romania

  • Stiftung Kathol. Krankenhaus Marienhospital Herne Klinik Mitte

    Herne, 44625, Germany

  • Sygehus Lillebælt, Vejle

    Vejle, 7100, Denmark

  • Tartu Uni Hospital

    Tartu, 51014, Estonia

  • The Northern Hospital

    Epping, Victoria, 3076, Australia

  • The Townsville Hospital

    Douglas, Queensland, 4814, Australia

  • Tiroler Landeskrankenanstalten Ges.M.B.H.

    Innsbruck, 6020, Austria

  • Tweed Hospital

    Tweed Heads, New South Wales, 2485, Australia

  • UC San Diego Health System

    La Jolla, California, 92093, United States

  • UMHAT " Sveti Georgi" Plovdiv - Clinic of Oncology and Hematology

    Plovdiv, 4002, Bulgaria

  • UMHAT Dr Georgi Stranski

    Pleven, 5800, Bulgaria

  • Uni Cattolica

    Rome, Lazio, 00168, Italy

  • Uniklinik RWTH Aachen

    Aachen, 52074, Germany

  • Uniklinikum "Carl Gustav Carus";Med. Klinik 1

    Dresden, 01307, Germany

  • Uniklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitaetsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitatsklinikum Tubingen

    Tübingen, 72076, Germany

  • University Hospital Center Zagreb

    Zagreb, 10000, Croatia

  • University Hospital Merkur Clinic for Internal Medicine/ Hematology

    Zagreb, 10000, Croatia

  • University Hospital Southampton NHS Foundation Trust

    Southhampton, SO16 6YD, United Kingdom

  • University Hospital Sv.Georgi Clnic of Hematology

    Plovdiv, 4002, Bulgaria

  • University Multiprofile Hospital For Active Treatment "Sveti Ivan Rilski" EAD

    Sofia, 1431, Bulgaria

  • Universitätsklinikum Essen

    Essen, 45122, Germany

  • Universitätsklinikum Köln

    Cologne, 50937, Germany

  • Universitätsspital Zürich Medizin Hämatologie

    Zurich, 8091, Switzerland

  • Universtitätsklinikum Ulm

    Ulm, 89081, Germany

  • Wellington Hospital

    Wellington, 6012, New Zealand

  • Western General Hospital

    Edinburgh, EH4 2XU, United Kingdom

  • Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • Wojewodzki Szpital Specjalistyczny im. J. Korczaka

    Słupsk, 76-200, Poland

  • Wojewódzki Szpital Specjalistyczny im. Miko?aja Kopernika

    Lodz, 9351, Poland

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