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
- Diseases
- Chronic lymphocytic leukaemia
- 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
Sites (59)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut Jules Bordet Coordinator of this site? Confirm its status | Anderlecht | Belgium | Active, not recruiting |
| JESSA Ziekenhuis Coordinator of this site? Confirm its status | Hasselt | Belgium | Active, not recruiting |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Active, not recruiting |
| Arthur J.E. Child Comprehensive Cancer Centre Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Juravinski Cancer Centre Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Jewish General Hospital Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Ottawa Hospital - General Campus Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
| Fakultni nemocnice Brno Coordinator of this site? Confirm its status | Brno | Czechia | Active, not recruiting |
| Fakultni Nemocnice Hradec Kralove Coordinator of this site? Confirm its status | Novy Hradec Kralove | Czechia | Active, not recruiting |
| Fakultni Nemocnice Plzen Coordinator of this site? Confirm its status | Plzen 23 | Czechia | Active, not recruiting |
| Fakultni Nemocnice Ostrava Coordinator of this site? Confirm its status | Poruba | Czechia | Active, not recruiting |
| Vseobecna Fakultni Nemocnice V Praze Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Active, not recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Infanta Leonor Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario de la Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire Reims Coordinator of this site? Confirm its status | Reims Cedex | France | Active, not recruiting |
| Institut Universitaire Du Cancer Toulouse-Oncopole Coordinator of this site? Confirm its status | Toulouse Cedex 9 | France | Active, not recruiting |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Active, not recruiting |
| Institut Gustave Roussy Coordinator of this site? Confirm its status | Villejuif | France | Active, not recruiting |
| Birmingham Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Queen Mary University of London Coordinator of this site? Confirm its status | Charterhouse Square | United Kingdom | Unknown status |
| New Victoria Hospital Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| St James's Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Derriford Hospital Coordinator of this site? Confirm its status | Plymouth | United Kingdom | Unknown status |
| Barking, Havering and Redbridge University Hospitals NHS trust Coordinator of this site? Confirm its status | Romford | United Kingdom | Unknown status |
| Royal Hallamshire Hospital Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| Carmel Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Bnai Zion Medical Center Coordinator of this site? Confirm its status | Haifa | Israel | Unknown status |
| Hadassah medical Center Coordinator of this site? Confirm its status | Jerusalem | Israel | Unknown status |
| Western Galilee Medical Center Coordinator of this site? Confirm its status | Nahariya | Israel | Unknown status |
| Sheba medical center Coordinator of this site? Confirm its status | Ramat Gan | Israel | Unknown status |
| Tel-Aviv Sourasky Medical Center Coordinator of this site? Confirm its status | Tel Aviv | Israel | Unknown status |
| Flevoziekenhuis Stichting Coordinator of this site? Confirm its status | Almere | Netherlands | Active, not recruiting |
| Academisch Medisch Centrum Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Active, not recruiting |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi Coordinator of this site? Confirm its status | Lodz | Poland | Active, not recruiting |
| Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o. Coordinator of this site? Confirm its status | Slupsk | Poland | Active, not recruiting |
| Instytut Hematologii I Transfuzjologii Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| S.P. Botkin Moscow City Clinical Hospital Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Moscow Multidisciplinary Scientific and Clinical Center named after S P Botkin Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizhniy Novgorod Region Clinical Hospital Coordinator of this site? Confirm its status | Nizhny Novgorod | Russia | Unknown status |
| Ryazan Regional Clinical Hospital Coordinator of this site? Confirm its status | Ryazan | Russia | Unknown status |
| FSBIFederal Centre of Heart, Blood and Endocrinology named after V.A.Almazov MoH of the RF Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| St.-Petersburg Clinical Research Institute of Hematology and Transfusiology Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Region Norrbotten Coordinator of this site? Confirm its status | Lulea | Sweden | Completed |
| Novant Health Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| John Theurer Cancer Center Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Norton Cancer Institute Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Gazi Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Universitesi Tip Fakultesi Cebeci Arastirma ve Uygulama Hastanesi Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| V K V Amerikan Hastanesi Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| Dokuz Eylul Universitesi Tip Fakultesi Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.