Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT05023980 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Pirtobrutinib
- DRUG Bendamustine
Study Locations (20)
Other
- Uniklinikum Salzburg — Salzburg
- Klinik Ottakring — Vienna
- UMHAT "Sveti Georgi" EAD — Plovdiv
- UMHAT 'Sv. Ivan Rilski', EAD — Sofia
- "SHATHD" EAD, Sofia — Sofia
- UMHAT - Prof. Dr. Stoyan Kirkovich" AD — Stara Zagora
Rio Grande do Sul
- Hospital de Clinicas de Porto Alegre — Porto Alegre
- Irmandade da Santa Casa de Misericórdia de Porto Alegre — Porto Alegre
- Centro Gaucho Integrado - Mae de Deus Center — Porto Alegre
California
- California Research Institute — Los Angeles
- Innovative Clinical Research Institute — Whittier
New South Wales
- Liverpool Hospital — Liverpool
- Westmead Hospital — Wentworthville
São Paulo
- Hemocentro Unicamp — Campinas
- Fundação Doutor Amaral Carvalho — Jaú
Florida
- Oncology-Hematology Associates of West Broward — Coral Springs
New Jersey
- New Jersey Center for Cancer Research — Brick
New York
- Clinical Research Alliance, Inc. — Westbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 309 participants |
| Start Date | 2021-09-23 |
| Est. Completion | 2027-10 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05023980
The ClinicalTrials.gov registry entry for NCT05023980 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 309 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loxo Oncology, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 3 interventions — of which Rituximab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05023980 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Rio Grande do Sul, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05023980 about?
NCT05023980 is a clinical study titled "A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)". 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.
What is the current status of trial NCT05023980?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 309 participants. The study started on 2021-09-23. Estimated completion is 2027-10.
What conditions does trial NCT05023980 study?
This clinical trial studies the following conditions: Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05023980?
The interventions under investigation include: Rituximab (DRUG), Pirtobrutinib (DRUG), Bendamustine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05023980?
This trial is sponsored by Loxo Oncology, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05023980 being conducted?
This trial has 20 study locations across California, Florida, New Jersey, New York, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.