NCT02910583CompletedPhase 2
Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL)
Phase 2 Study of the Combination of Ibrutinib Plus Venetoclax in Subjects With Treatment-naïve Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
This is a multicenter, 2-cohort Phase 2 study assessing both minimal residual disease (MRD)-guided discontinuation and fixed duration therapy with the combination of ibrutinib + venetoclax in subjects with treatment-naïve CLL or SLL.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 323 (actual)
- First submitted
- 20 Sept 2016
- Start date
- 28 Sept 2016
- Primary completion date
- 12 Nov 2020
- Lead sponsor
- Pharmacyclics LLC.
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT02910583
- EudraCT number
- 2016-002293-12
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 323
- From 28 Sept 2016 to the primary completion date, 12 Nov 2020
- 46 sites in 6 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
- Any prior therapy used for treatment of CLL/SLL
Other illness
- Known allergy to xanthine oxidase inhibitors and/or rasburicase for subjects at risk for tumor lysis syndrome (TLS)
Who the study is looking for
- Diagnosis of CLL/SLL that meets 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria (Hallek et al), with active disease meeting at least 1 IWCLL criteria for requiring treatment.
- Measurable nodal disease by computed tomography (CT)
- Adequate hepatic, and renal function
- Adequate hematologic function
- absolute neutrophil count \>750/µL
- platelet count \>30,000 /μL
- hemoglobin \>8.0 g/dL
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (46)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre /ID# 1142-0163 Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Monash Medical Centre /ID# 1142-0556 Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Peter MacCallum Cancer Centre-East Melbourne /ID# 1142-0633 Coordinator of this site? Confirm its status | East Melbourne | Australia | Unknown status |
| St Vincent's Hospital Melbourne /ID# 1142-0501 Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Frankston Hospital /ID# 1142-0715 Coordinator of this site? Confirm its status | Frankston | Australia | Unknown status |
| Austin Health /ID# 1142-0170 Coordinator of this site? Confirm its status | Heidelberg | Australia | Unknown status |
| St George Hospital /ID# 1142-0654 Coordinator of this site? Confirm its status | Kogarah | Australia | Unknown status |
| Hospital Clinic de Barcelona /ID# 1142-0533 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Santa Creu i Sant Pau /ID# 1142-0535 Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Universitario Virgen de las Nieves /ID# 1142-1196 Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Hospital Duran i Reynals /ID# 1142-0604 Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Unknown status |
| Hospital Universitario Ramon y Cajal /ID# 1142-0874 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario 12 de Octubre /ID# 1142-0864 Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hospital Universitario Puerta de Hierro, Majadahonda /ID# 1142-0536 Coordinator of this site? Confirm its status | Majadahonda | Spain | Unknown status |
| Complejo Hospitalario de Navarra /ID# 1142-1197 Coordinator of this site? Confirm its status | Pamplona | Spain | Unknown status |
| Hospital Clinico Universitario de Salamanca /ID# 1142-0790 Coordinator of this site? Confirm its status | Salamanca | Spain | Unknown status |
| Ospedale Policlinico San Martino /ID# 1142-0903 Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| ASST Grande Ospedale Metropolitano Niguarda /ID# 1142-0581 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale San Raffaele IRCCS /ID# 1142-0523 Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Ospedaliero-Universitaria di Modena /ID# 1142-0524 Coordinator of this site? Confirm its status | Modena | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Maggiore della Carita di Novara /ID# 1142-0582 Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| Azienda Ospedaliera di Padova /ID# 1142-1175 Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Azienda USL di Piacenza - Ospedale Guglielmo da Saliceto /ID# 1142-1182 Coordinator of this site? Confirm its status | Piacenza | Italy | Unknown status |
| North Shore Hospital /ID# 1142-0663 Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital /ID# 1142-0589 Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Middlemore Hospital /ID# 1142-0662 Coordinator of this site? Confirm its status | Otahuhu | New Zealand | Unknown status |
| Palmerston North Hospital /ID# 1142-0585 Coordinator of this site? Confirm its status | Palmerston North | New Zealand | Unknown status |
| Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. ks. B. /ID# 1142-0592 Coordinator of this site? Confirm its status | Brzozów | Poland | Unknown status |
| Samodzielny Publiczny Szpital Klinczny Nr-1- Akademickie Cenrum Klinic /ID# 1142-0529 Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| Malopolskie Centrum Medyczne /ID# 1142-0364 Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Medical Univ. of Lodz and Copernicus Memorial Hospital /ID# 1142-0531 Coordinator of this site? Confirm its status | Lodz | Poland | Unknown status |
| Duplicate_Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie /ID# 1142-0590 Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Charlotte-Mecklenberg Hospital, Carolinas Healthcare System, Levine Cancer Inst /ID# 1142-0733 Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Tennessee Oncology - Chattanooga /ID# 1142-0123 Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| Cleveland Clinic Foundation /ID# 1142-0739 Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| City of Hope /ID# 1142-0047 Coordinator of this site? Confirm its status | Duarte | United States | Unknown status |
| MD Anderson Cancer Center /ID# 1142-0032 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Moores Cancer Center at UC San Diego /ID# 1142-0241 Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Norton Cancer Center /ID# 1142-0071 Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Rutgers Cancer Institute of New Jersey /ID# 1142-1193 Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Northwell Health/Long Island Jewish Hospital /ID# 1142-0350 Coordinator of this site? Confirm its status | New Hyde Park | United States | Unknown status |
| New York Presbyterian Hospital/Weill Cornell Med College /ID# 1142-0200 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UC Irvine Medical Center - Chao Family Comprehensive Cancer Center /ID# 1142-0008 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| University of Pennsylvania /ID# 1142-0069 Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Rochester Cancer Center /ID# 1142-0127 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Swedish Cancer Institute /ID# 1142-0114 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
Related publications
- Venetoclax retreatment in chronic lymphocytic leukemia is biologically rational and clinically effective.Blood Adv · 2026 · PMID 41843779
This page is information, not medical advice. Discuss any trial with your doctor.