🏛️ 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
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull 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.
More studies in Chronic Lymphocytic Leukemia
- Acalabrutinib and Obinutuzumab for the Treatment of Chronic Lymphocytic Leukemia — Houston, Texas
- Pirtobrutinib and Venetoclax With MRD Detection for Previously Untreated Chronic Lymphocytic Leukemia — Rochester, Minnesota
- A Study of Zilovertamab Vedotin (MK-2140) as Monotherapy and in Combination in Participants With Aggressive and Indolent B-cell Malignancies (MK-2140-006) — Anchorage, Alaska
- Economic Analysis of Alliance A041202 CLL Study — Calgary, Alberta
- A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL — Chandler, Arizona
- Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL) — Phoenix, Arizona
Explore by condition: All Chronic Lymphocytic Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.