Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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)
NCT03462719 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- DRUG Obinutuzumab
- DRUG Venetoclax
- DRUG Ibrutinib
- DRUG Chlorambucil
- DRUG Ibrutinib (as Subsequent Therapy)
Study Locations (20)
Other
- Institut - Jules Bordet — Anderlecht
- ZNA Stuivenberg — Antwerp
- Universitair Ziekenhuis Gent — Ghent
- Virga Jessa Ziekenhuis — Hasselt
- UZ Leuven Gasthuisberg — Leuven
- Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika — Brno
- Fakultni nemocnice Hradec Kralove — Hradec Králové
- Fakultni Nemocnice Ostrava — Ostrava
- Fakultni nemocnice Plzen, Hemato-onkologicke oddeleni — Pilsen
- Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie — Prague
- Aalborg University Hospital — Aalborg
Alberta
- Arthur J E Child Comprehensive Cancer Centre — Calgary
- Cross Cancer Institute — Edmonton
Ontario
- Juravinski Cancer Centre — Hamilton
- The Ottawa Hospital - General Campus — Ottawa
Quebec
- CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont — Montreal
- Jewish General Hospital — Montreal
Kentucky
- Norton Cancer Institute — Louisville
New Jersey
- John Theurer Cancer Center — Hackensack
North Carolina
- Novant Health — Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 211 participants |
| Start Date | 2018-04-17 |
| Est. Completion | 2029-04-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03462719
The ClinicalTrials.gov registry entry for NCT03462719 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 211 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Leukemia, Lymphocytic, Chronic, B-Cell appearing as the primary indexed condition, and to 5 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03462719 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Other, Alberta, Ontario. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03462719 about?
NCT03462719 is a clinical study titled "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)". 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).
What is the current status of trial NCT03462719?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 211 participants. The study started on 2018-04-17. Estimated completion is 2029-04-05.
What conditions does trial NCT03462719 study?
This clinical trial studies the following conditions: Leukemia, Lymphocytic, Chronic, B-Cell. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03462719?
The interventions under investigation include: Obinutuzumab (DRUG), Venetoclax (DRUG), Ibrutinib (DRUG), Chlorambucil (DRUG), Ibrutinib (as Subsequent Therapy) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03462719?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03462719 being conducted?
This trial has 20 study locations across Kentucky, New Jersey, North Carolina, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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