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)
Running, not enrolling · Phase 3
Conditions studied: Leukemia, Lymphocytic, Chronic, B-Cell
In brief
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).
Key facts
- Study ID
- NCT03462719
- Run by
- Janssen Research & Development, LLC
- People needed
- 211
- Starts
- 2018-04-17
- Expected to finish
- 2029-04-05
- Last updated by the study team
- 2026-07-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- John Theurer Cancer Center — Hackensack, New Jersey, United States
- Novant Health — Charlotte, North Carolina, United States
- Institut - Jules Bordet — Anderlecht, Belgium
- ZNA Stuivenberg — Antwerp, Belgium
- Universitair Ziekenhuis Gent — Ghent, Belgium
- Virga Jessa Ziekenhuis — Hasselt, Belgium
- UZ Leuven Gasthuisberg — Leuven, Belgium
- Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
- Cross Cancer Institute — Edmonton, Alberta, Canada
- Juravinski Cancer Centre — Hamilton, Ontario, Canada
- The Ottawa Hospital - General Campus — Ottawa, Ontario, Canada
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada
- Jewish General Hospital — Montreal, Quebec, Canada
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika — Brno, Czechia
- Fakultni nemocnice Hradec Kralove — Hradec Králové, Czechia
- Fakultni Nemocnice Ostrava — Ostrava, Czechia
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni — Pilsen, Czechia
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie — Prague, Czechia
- Aalborg University Hospital — Aalborg, Denmark
- Aarhus Universitetshospital — Aarhus, Denmark
- Rigshospitalet 1 — Copenhagen, Denmark
- Rigshospitalet — Copenhagen, Denmark
- Odense Universitetshospital — Odense C, Denmark
- Roskilde Sygehus — Roskilde, Denmark
- Norton Cancer Institute — Louisville, Kentucky, United States
Full record on ClinicalTrials.gov
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