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NCT03462719Active, not recruitingPhase 3

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)

A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL).

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
211 (actual)
First submitted
6 Mar 2018
Start date
17 Apr 2018
Primary completion date
26 Feb 2021
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT03462719
EU CT number
2023-503469-49-00
EudraCT number
2017-004699-77

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 211
  • From 17 Apr 2018 to the primary completion date, 26 Feb 2021
  • 59 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior anti-leukemic therapy for CLL or SLL
  • Major surgery within 4 weeks of first dose of study treatment

Other illness

  • Known bleeding disorders (example, von Willebrand's disease or hemophilia)
  • Central nervous system (CNS) involvement or suspected Richter's syndrome

Other

  • 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)

Who the study is looking for

  • 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:
    • Cumulative Illness Rating Scale (CIRS) score \> 6
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (59)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Institut Jules Bordet
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AnderlechtBelgiumActive, not recruiting
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Arthur J.E. Child Comprehensive Cancer Centre
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CalgaryCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Juravinski Cancer Centre
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HamiltonCanadaUnknown status
CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont
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MontrealCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
The Ottawa Hospital - General Campus
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OttawaCanadaUnknown status
Fakultni nemocnice Brno
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BrnoCzechiaActive, not recruiting
Fakultni Nemocnice Hradec Kralove
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Novy Hradec KraloveCzechiaActive, not recruiting
Fakultni Nemocnice Plzen
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Plzen 23CzechiaActive, not recruiting
Fakultni Nemocnice Ostrava
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PorubaCzechiaActive, not recruiting
Vseobecna Fakultni Nemocnice V Praze
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Prague 2CzechiaActive, not recruiting
Rigshospitalet
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Copenhagen OeDenmarkActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Infanta Leonor
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MadridSpainActive, not recruiting
Hospital Universitario de la Princesa
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MadridSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceActive, not recruiting
Institut Universitaire Du Cancer Toulouse-Oncopole
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Toulouse Cedex 9FranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
Birmingham Heartlands Hospital
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BirminghamUnited KingdomUnknown status
Addenbrookes Hospital
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CambridgeUnited KingdomUnknown status
Queen Mary University of London
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Charterhouse SquareUnited KingdomUnknown status
New Victoria Hospital
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GlasgowUnited KingdomUnknown status
St James's Hospital
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LeedsUnited KingdomUnknown status
Derriford Hospital
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PlymouthUnited KingdomUnknown status
Barking, Havering and Redbridge University Hospitals NHS trust
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RomfordUnited KingdomUnknown status
Royal Hallamshire Hospital
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SheffieldUnited KingdomUnknown status
Carmel Medical Center
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HaifaIsraelUnknown status
Bnai Zion Medical Center
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HaifaIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Western Galilee Medical Center
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NahariyaIsraelUnknown status
Sheba medical center
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Ramat GanIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Flevoziekenhuis Stichting
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AlmereNetherlandsActive, not recruiting
Academisch Medisch Centrum
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AmsterdamNetherlandsActive, not recruiting
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
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LodzPolandActive, not recruiting
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
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SlupskPolandActive, not recruiting
Instytut Hematologii I Transfuzjologii
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WarsawPolandActive, not recruiting
S.P. Botkin Moscow City Clinical Hospital
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MoscowRussiaUnknown status
Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin
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MoscowRussiaUnknown status
Nizhniy Novgorod Region Clinical Hospital
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Nizhny NovgorodRussiaUnknown status
Ryazan Regional Clinical Hospital
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RyazanRussiaUnknown status
FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF
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Saint PetersburgRussiaUnknown status
St.-Petersburg Clinical Research Institute of Hematology and Transfusiology
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Saint PetersburgRussiaUnknown status
Region Norrbotten
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LuleaSwedenCompleted
Novant Health
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CharlotteUnited StatesUnknown status
John Theurer Cancer Center
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HackensackUnited StatesUnknown status
Norton Cancer Institute
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LouisvilleUnited StatesUnknown status
Gazi Universitesi Tip Fakultesi
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AnkaraTurkey (Türkiye)Unknown status
Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi
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AnkaraTurkey (Türkiye)Unknown status
V K V Amerikan Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Dokuz Eylul Universitesi Tip Fakultesi
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IzmirTurkey (Türkiye)Unknown status
Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi
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SamsunTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.