A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Last updated: March 27, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Leukemia

Treatment

Chlorambucil

Ibrutinib

Obinutuzumab

Clinical Study ID

NCT03462719
CR108428
2017-004699-77
54179060CLL3011
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee (IRC).

Eligibility Criteria

Inclusion

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 onelymph node > 1.5 centimeter (cm) in longest diameter

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Grade less than orequal to (<=) 2

  • Active CLL/SLL requiring treatment per the iwCLL criteria

Exclusion

Exclusion Criteria:

  • Prior anti-leukemic therapy for CLL or SLL

  • Presence of deletion of the short arm of chromosome 17 (del17p) or known TP53mutation 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

Study Design

Total Participants: 211
Treatment Group(s): 5
Primary Treatment: Chlorambucil
Phase: 3
Study Start date:
April 17, 2018
Estimated Completion Date:
April 05, 2029

Connect with a study center

  • Institut - Jules Bordet

    Anderlecht, 1070
    Belgium

    Site Not Available

  • ZNA Stuivenberg

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Institut - Jules Bordet

    Brussel, 1000
    Belgium

    Site Not Available

  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

    Site Not Available

  • Virga Jessa Ziekenhuis

    Hasselt, 3500
    Belgium

    Site Not Available

  • UZ Leuven Gasthuisberg

    Leuven, 3000
    Belgium

    Site Not Available

  • Arthur J E Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • Arthur J. E. Child Comprehensive Cancer Centre

    Calgary, Alberta T2N 5G2
    Canada

    Site Not Available

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

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

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • CIUSSS de l'Est-de-l'Île-de-Montréal Installation Hôpital Maisonneuve-Rosemont

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni nemocnice Hradec Kralove

    Hradec Kralove, 500 05
    Czechia

    Site Not Available

  • Fakultni Nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52
    Czechia

    Site Not Available

  • Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni

    Plzen, 323 00
    Czechia

    Site Not Available

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

    Praha 2, 128 08
    Czechia

    Site Not Available

  • Aalborg University Hospital

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus, 8200
    Denmark

    Site Not Available

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Site Not Available

  • Herlev Hospital

    Herlev, 2730
    Denmark

    Site Not Available

  • Odense Universitetshospital

    Odense C, 5000
    Denmark

    Site Not Available

  • Roskilde Sygehus

    Roskilde, DK- 4000
    Denmark

    Site Not Available

  • CHU de Clermont Ferrand

    Clermont Ferrand, 63000
    France

    Site Not Available

  • CHU de Clermont-Ferrand

    Clermont Ferrand, 63000
    France

    Site Not Available

  • Hopital Claude Huriez

    Lille, 59000
    France

    Site Not Available

  • CHU Montpellier

    Montpellier, 34295
    France

    Site Not Available

  • Hopital Haut Leveque Service Maladie Du Sang

    Pessac, 33604
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Reims, Hôpital Robert Debré

    Reims, 51100
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse Oncopole

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • CHU Bretonneau

    Tours Cedex 9, 37044
    France

    Site Not Available

  • CHU-Nancy

    Vandoeuvre les Nancy, 54511
    France

    Site Not Available

  • Institut Gustave Roussy

    Villejuif, 94805
    France

    Site Not Available

  • Bnai Zion Medical Center

    Haifa, 31048
    Israel

    Site Not Available

  • Carmel Medical Center

    Haifa, 34362
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, 9112001
    Israel

    Site Not Available

  • Western Galilee Medical Center

    Nahariya, 22100
    Israel

    Site Not Available

  • Sheba Medical Center

    Ramat Gan, 52621
    Israel

    Site Not Available

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239
    Israel

    Site Not Available

  • Flevoziekenhuis

    Almere, 1315RA
    Netherlands

    Site Not Available

  • Academic Medical Center

    Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • OLVG

    Amsterdam, 1091AC
    Netherlands

    Site Not Available

  • Reinier de Graaf Gasthuis

    Delft, 2625 AD
    Netherlands

    Site Not Available

  • MC Haaglanden

    Den Haag, 2512 VA
    Netherlands

    Site Not Available

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318 AT
    Netherlands

    Site Not Available

  • Catharinaziekenhuis

    Eindhoven, 5623 EJ
    Netherlands

    Site Not Available

  • Spaarne Gasthuis

    Hoofddorp, 2134 TM
    Netherlands

    Site Not Available

  • Zuyderland Medical Center

    Sittard-Geleen, 6162 BG
    Netherlands

    Site Not Available

  • Antonius hospital

    Sneek, 8601 ZK
    Netherlands

    Site Not Available

  • Elisabeth zkh

    Tilburg, 5022 GC
    Netherlands

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzow, 41-500
    Poland

    Site Not Available

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich

    Chorzów, 41-500
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-952
    Poland

    Site Not Available

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

    Lodz, 93 510
    Poland

    Site Not Available

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

    Lodz, 93-510
    Poland

    Site Not Available

  • Samodzielny Publiczny Szpital Kliniczny Nr 1

    Lublin, 20-081
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie

    Lublin, 20-081
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im Janusza Korczaka

    Slupsk, 76-200
    Poland

    Site Not Available

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka,

    Slupsk, 76-200
    Poland

    Site Not Available

  • Instytut Hematologii i Transfuzjologii

    Warszawa, 02 776
    Poland

    Site Not Available

  • Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku SPSK nr 1

    Wroclaw, 50-367
    Poland

    Site Not Available

  • Clinical Oncology Center of Tatarstan

    Kazan, 420029
    Russian Federation

    Site Not Available

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

    Moscow, 125284
    Russian Federation

    Site Not Available

  • S.P. Botkin Moscow City Clinical Hospital

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Nizhniy Novgorod Region Clinical Hospital

    Nizhny Novgorod, 603126
    Russian Federation

    Site Not Available

  • Ryazan Regional Clinical Hospital

    Ryazan, 390039
    Russian Federation

    Site Not Available

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

    Saint Petersburg, 197341
    Russian Federation

    Site Not Available

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

    St. Petersburg, 193024
    Russian Federation

    Site Not Available

  • Hosp Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp Univ Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hosp. Clinic I Provincial de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Clinic de Barcelona

    Barcelona, 08036
    Spain

    Site Not Available

  • Hosp. Univ. Vall D Hebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hosp. de La Santa Creu I Sant Pau

    Barcelona, 8041
    Spain

    Site Not Available

  • Hosp. de la Santa Creu i Sant Pau

    Barcelona, 8041
    Spain

    Site Not Available

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Maranon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Gral. Univ. Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hosp. Univ. Fund. Jimenez Diaz

    Madrid, 28040
    Spain

    Site Not Available

  • Hosp. Univ. Infanta Leonor

    Madrid, 28031
    Spain

    Site Not Available

  • Hosp. Univ. de La Princesa

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital Ramon y Cajal

    Madrid, 28034
    Spain

    Site Not Available

  • Clinica Univ. de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Clinico Universitario Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hosp. Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Sunderby Sjukhus Medicinkliniken

    Luelå, 97180
    Sweden

    Site Not Available

  • Skanes universitetssjukhus

    Lund, 22185
    Sweden

    Site Not Available

  • Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm

    Stockholm, 171 76
    Sweden

    Site Not Available

  • Ankara Universitesi Tip Fakültesi Ibn-i Sina Hastanesi

    Ankara, 6590
    Turkey

    Site Not Available

  • Gazi Universitesi Tip FalKultesi

    Ankara, 06500
    Turkey

    Site Not Available

  • Ondokuz Mayis Universitesi Tip Fakultesi

    Atakum, 55270
    Turkey

    Site Not Available

  • Ondokuz Mayis Universitesi Tip Fakultesiy

    Atakum, 55270
    Turkey

    Site Not Available

  • Ondokuz Mayis University

    Atakum, 55270
    Turkey

    Site Not Available

  • V K V Amerikan Hastanesi

    Istanbul, 34365
    Turkey

    Site Not Available

  • V.K.V. Amerikan Hastanesi

    Istanbul, 34365
    Turkey

    Site Not Available

  • Dokuz Eylul Universitesi Tip Fakultesi

    Izmir, 35340
    Turkey

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5ST
    United Kingdom

    Site Not Available

  • Royal Bournemouth Hospital

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Site Not Available

  • Queen Mary University of London

    Charterhouse Square, EC1M 6BQ
    United Kingdom

    Site Not Available

  • New Victoria Hospital

    Glasgow, G42 9LF
    United Kingdom

    Site Not Available

  • St James's Hospital

    Leeds, LS9 7T
    United Kingdom

    Site Not Available

  • Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Barking Havering and Redbridge University Hospitals NHS Trust

    Romford, RM7 0AG
    United Kingdom

    Site Not Available

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • University of California San Diego Medical Center

    La Jolla, California 92093
    United States

    Site Not Available

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Norton Cancer Institute

    Louisville, Kentucky 40207
    United States

    Site Not Available

  • John Theurer Cancer Center

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Novant Health

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Gettysburg Cancer Center

    Gettysburg, Pennsylvania 17325
    United States

    Site Not Available

  • Swedish Cancer Institute

    Seattle, Washington 98104
    United States

    Site Not Available

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