🏛️ Verified NIH Record • Updated 2026-01-21

A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (NCT05023980)

A Phase 3 Open-Label, Randomized Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab in Untreated Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Loxo Oncology, Inc.

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

The purpose of this study is to compare the efficacy and safety of pirtobrutinib (LOXO-305; Arm A) compared to BR (Arm B) in patients with CLL/SLL who have not been treated. Participation could last up to five years.

Who can join: Review the eligibility criteria below.

Location: California Research Institute — Los Angeles, California

Age range: 18 Years

📋 "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 (108 Sites)

Showing the first 25 of 108 sites.

  • California Research Institute — Los Angeles, California
  • Innovative Clinical Research Institute — Whittier, California
  • Oncology-Hematology Associates of West Broward — Coral Springs, Florida
  • New Jersey Center for Cancer Research — Brick, New Jersey
  • Clinical Research Alliance, Inc. — Westbury, New York
  • Liverpool Hospital — Liverpool, New South Wales
  • Westmead Hospital — Wentworthville, New South Wales
  • Peninsula Private Hospital — Frankston, Victoria
  • Uniklinikum Salzburg — Salzburg,
  • Klinik Ottakring — Vienna,
  • Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul
  • Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande do Sul
  • Centro Gaucho Integrado - Mae de Deus Center — Porto Alegre, Rio Grande do Sul
  • Hemocentro Unicamp — Campinas, São Paulo
  • Fundação Doutor Amaral Carvalho — Jaú, São Paulo
  • UMHAT "Sveti Georgi" EAD — Plovdiv,
  • UMHAT 'Sv. Ivan Rilski', EAD — Sofia,
  • "SHATHD" EAD, Sofia — Sofia,
  • UMHAT - Prof. Dr. Stoyan Kirkovich" AD — Stara Zagora,
  • Anhui Provincial Cancer Hospital — Hefei, Anhui
  • Peking University First Hospital — Beijing, Beijing Municipality
  • Peking University Third Hospital — Beijing, Beijing Municipality
  • The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong
  • Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei
  • Xiangya Hospital Central South University — Changsha, Hunan

💰 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. 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.
🏛️ View Official NIH Record ↗