🏛️ Verified NIH Record • Updated 2026-08-14

A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (NCT05254743)

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN-CLL-314)

🟢 Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Loxo Oncology, Inc.

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

The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.

Who can join: Review the eligibility criteria below.

Location: Pacific Cancer Medical Center, Inc — Anaheim, California

Age range: 18 Years

🧪 Interventions in This Study

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

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (143 Sites)

Showing the first 25 of 143 sites.

  • Pacific Cancer Medical Center, Inc — Anaheim, California
  • TOI Clinical Research — Cerritos, California
  • Stanford School of Medicine-Cancer Clinical Trials Office — Palo Alto, California
  • California Cancer Associates for Research and Excellence — San Marcos, California
  • Florida Cancer Specialists — Fort Myers, Florida
  • Cancer Specialists of North Florida -St Augustine — Saint Augustine, Florida
  • Florida Cancer Specialists East — West Palm Beach, Florida
  • Hematology Oncology Clinic — Baton Rouge, Louisiana
  • Tulane Cancer Center Office of Clinical Research — New Orleans, Louisiana
  • American Oncology Partners of Maryland, PA — Bethesda, Maryland
  • St. Vincent Frontier Cancer Center — Billings, Montana
  • Cancer Care Associates Of York — York, Pennsylvania
  • Prisma Health Cancer Institute — Greenville, South Carolina
  • Sarah Cannon Research Institute SCRI — Nashville, Tennessee
  • Kelsey Research Foundation — Houston, Texas
  • Lumi Research — Kingwood, Texas
  • Virginia Cancer Institute — Richmond, Virginia
  • Medical Oncology Associates, PS — Spokane, Washington
  • MultiCare Health System Institute for Research and Innovation — Spokane, Washington
  • Alexander Fleming — Ciudad Autónoma de Buenos Aire,
  • Hospital Privado De Comunidad — Mar del Plata,
  • Clínica de Nefrología, Urología y Enfermedades Cardiovasculares — Santa Fe,
  • One Clinical Research — Nedlands,
  • Western Health, Sunshine Hospital — St Albans,
  • The Perth Blood Institute — West Perth,

📞 Contact the Study Coordinator

Phone: (317) 615-4559

Email: LillyTrials@Lilly.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 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.

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  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.
🏛️ View Official NIH Record ↗