🏛️ Verified NIH Record • Updated 2026-07-02

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)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

🩺 Plain-English Summary (8th-Grade Level)

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).

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (6 items).

Location: Norton Cancer Institute — Louisville, Kentucky

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (88 Sites)

  • Norton Cancer Institute — Louisville, Kentucky
  • John Theurer Cancer Center — Hackensack, New Jersey
  • Novant Health — Charlotte, North Carolina
  • Institut - Jules Bordet — Anderlecht,
  • ZNA Stuivenberg — Antwerp,
  • Universitair Ziekenhuis Gent — Ghent,
  • Virga Jessa Ziekenhuis — Hasselt,
  • UZ Leuven Gasthuisberg — Leuven,
  • Arthur J E Child Comprehensive Cancer Centre — Calgary, Alberta
  • Cross Cancer Institute — Edmonton, Alberta
  • Juravinski Cancer Centre — Hamilton, Ontario
  • The Ottawa Hospital - General Campus — Ottawa, Ontario
  • CIUSSS de l Est de l Ile de Montreal Installation Hopital Maisonneuve Rosemont — Montreal, Quebec
  • Jewish General Hospital — Montreal, Quebec
  • 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,
  • Aarhus Universitetshospital — Aarhus,
  • Rigshospitalet 1 — Copenhagen,
  • Rigshospitalet — Copenhagen,
  • Odense Universitetshospital — Odense C,
  • Roskilde Sygehus — Roskilde,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
🏛️ View Official NIH Record ↗