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New drug cocktail shows promise in battling blood cancer

NCT ID NCT03462719

Disease control Sponsor: Janssen Research & Development, LLC 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 01, 2026 · Updated 4 times

Summary

This phase 3 study tests whether a combination of two targeted drugs, ibrutinib and venetoclax, works better than the current standard therapy (chlorambucil plus obinutuzumab) for adults with chronic lymphocytic leukemia (CLL) who have not yet been treated. The main goal is to see how long people live without their cancer getting worse. Participants are 65 years or older, or younger adults with other health issues. The study is no longer recruiting new participants.

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

211 people

The number who actually took part.

Started

Apr 2018

Expected to finish

Apr 2029

An estimate. End dates often move.

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: * Adult participants who are: (a) greater than or equal to (\>=) 65 years old or, (b) 18 to 64 years old and have at least 1 of the following: 1. Cumulative Illness Rating Scale (CIRS) score \> 6 2. Creatinine clearance (CrCl) estimated less than (\<) 70 milliliter per minute (mL/min) using Cockcroft-Gault equation * Diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Measurable nodal disease (by computed tomography \[CT\]), defined as at least one lymph node \> 1.5 centimeter (cm) in longest diameter * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than or equal to (\<=) 2 * Active CLL/SLL requiring treatment per the iwCLL criteria Exclusion Criteria: * Prior anti-leukemic therapy for CLL or SLL * Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53 mutation detected at a threshold of \>10 percent (%) variable allele frequency (VAF) * Major surgery within 4 weeks of first dose of study treatment * Known bleeding disorders (example, von Willebrand's disease or hemophilia) * Central nervous system (CNS) involvement or suspected Richter's syndrome

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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.

Leukemia, lymphocytic, chronic, B-cell

Contacts and locations

Locations

  • Aalborg University Hospital

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Academic Medical Center

    Amsterdam, 1105 AZ, Netherlands

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ, United Kingdom

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT, Netherlands

  • Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi

    Ankara, 06620, Turkey (Türkiye)

  • Antonius hospital

    Sneek, 8601 ZK, Netherlands

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2, Canada

  • Barking Havering and Redbridge University Hospitals NHS Trust

    Romford, RM7 0AG, United Kingdom

  • Birmingham Heartlands Hospital

    Birmingham, B9 5ST, United Kingdom

  • Bnai Zion Medical Center

    Haifa, 31048, Israel

  • CHU Bretonneau

    Tours, 37044, France

  • CHU Montpellier

    Montpellier, 34295, France

  • CHU de Clermont Ferrand

    Clermont-Ferrand, 63000, France

  • CHU-Nancy

    Vandœuvre-lès-Nancy, 54511, France

  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont

    Montreal, Quebec, H1T 2M4, Canada

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Catharinaziekenhuis

    Eindhoven, 5623 EJ, Netherlands

  • Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

    Reims, 51100, France

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2, Canada

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340, Turkey (Türkiye)

  • Elisabeth zkh

    Tilburg, 5022 GC, Netherlands

  • FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF

    Saint Petersburg, 197341, Russia

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52, Czechia

  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

    Brno, 625 00, Czechia

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05, Czechia

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

    Pilsen, 323 00, Czechia

  • Flevoziekenhuis

    Almere Stad, 1315RA, Netherlands

  • Gazi Universitesi Tip Fakultesi

    Ankara, 06500, Turkey (Türkiye)

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hopital Claude Huriez

    Lille, 59000, France

  • Hopital Haut Leveque Service Maladie Du Sang

    Pessac, 33604, France

  • Hosp Clinic de Barcelona

    Barcelona, 08036, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007, Spain

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031, Spain

  • Hosp. Univ. de La Princesa

    Madrid, 28006, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 08041, Spain

  • Hospital Clinico Universitario Salamanca

    Salamanca, 37007, Spain

  • Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • Institut - Jules Bordet

    Anderlecht, 1070, Belgium

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse, 31059, France

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02 776, Poland

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • John Theurer Cancer Center

    Hackensack, New Jersey, 07601, United States

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2, Canada

  • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

    Stockholm, 171 76, Sweden

  • MC Haaglanden

    The Hague, 2512 VA, Netherlands

  • Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin

    Moscow, 125284, Russia

  • New Victoria Hospital

    Glasgow, G42 9LF, United Kingdom

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126, Russia

  • Norton Cancer Institute

    Louisville, Kentucky, 40207, United States

  • Novant Health

    Charlotte, North Carolina, 28204, United States

  • OLVG

    Amsterdam, 1091AC, Netherlands

  • Odense Universitetshospital

    Odense C, 5000, Denmark

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55280, Turkey (Türkiye)

  • Queen Mary University of London

    Charterhouse Square, EC1M 6BQ, United Kingdom

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD, Netherlands

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rigshospitalet 1

    Copenhagen, 2100, Denmark

  • Roskilde Sygehus

    Roskilde, DK- 4000, Denmark

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039, Russia

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284, Russia

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500, Poland

  • Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM, Netherlands

  • St James's Hospital

    Leeds, LS9 7T, United Kingdom

  • St.-Petersburg Clinical Research Institute of Hematology and Transfusiology

    Saint Petersburg, 193024, Russia

  • Sunderby Sjukhus Medicinkliniken

    Luelå, 97180, Sweden

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • UZ Leuven Gasthuisberg

    Leuven, 3000, Belgium

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20-081, Poland

  • V K V Amerikan Hastanesi

    Istanbul, 34365, Turkey (Türkiye)

  • Virga Jessa Ziekenhuis

    Hasselt, 3500, Belgium

  • Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie

    Prague, 128 08, Czechia

  • Western Galilee Medical Center

    Nahariya, 22100, Israel

  • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka

    Słupsk, 76-200, Poland

  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im M Kopernika w Lodzi

    Lodz, 93 510, Poland

  • ZNA Stuivenberg

    Antwerp, 2060, Belgium

  • Zuyderland Medical Center

    Sittard-Geleen, 6162 BG, Netherlands

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