๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-01-27

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (NCT04965493)

A Phase 3 Open-Label, Randomized Study of Fixed Duration Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab Versus Venetoclax and Rituximab in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Loxo Oncology, Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Who can join: Review the eligibility criteria below.

Location: Ironwood Physicians, Ironwood Cancer and Research Centers โ€” Chandler, Arizona

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (176 Sites)

Showing the first 25 of 176 sites.

  • Ironwood Physicians, Ironwood Cancer and Research Centers โ€” Chandler, Arizona
  • Mayo Clinic Hospital โ€” Phoenix, Arizona
  • University of California Irvine Medical Center โ€” Orange, California
  • Scripps Mercy Hospital โ€” San Diego, California
  • Providence Medical Foundation โ€” Santa Rosa, California
  • Stamford Hospital โ€” Stamford, Connecticut
  • Florida Cancer Specialists โ€” Fort Myers, Florida
  • Cancer Specialists of North Florida -St Augustine โ€” Saint Augustine, Florida
  • Florida Cancer Specialists East โ€” West Palm Beach, Florida
  • Mission Cancer and Blood โ€” Des Moines, Iowa
  • Pikeville Medical Center, Inc. โ€” Pikeville, Kentucky
  • American Oncology Partners of Maryland, PA โ€” Bethesda, Maryland
  • Dana-Farber Cancer Institute โ€” Boston, Massachusetts
  • St. Joseph Mercy Hospital โ€” Ann Arbor, Michigan
  • University of Michigan โ€” Ann Arbor, Michigan
  • Mayo Clinic โ€” Rochester, Minnesota
  • Research Medical Center โ€” Kansas City, Missouri
  • John Theurer Cancer Center at Hackensack University Medical Center โ€” Hackensack, New Jersey
  • The Mount Sinai Hospital โ€” New York, New York
  • Columbia University Medical Center โ€” New York, New York
  • Memorial Sloan Kettering Cancer Center โ€” New York, New York
  • Levine Cancer Institute โ€” Charlotte, North Carolina
  • Novant Cancer Institute Charlotte โ€” Charlotte, North Carolina
  • Duke University Medical Center โ€” Durham, North Carolina
  • Regional Medical Oncology Center โ€” Wilson, North Carolina

๐Ÿ’ฐ 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 ยง 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.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—