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)
Public ClinicalTrials.gov record NCT04965493. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04965493
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 20, 2021 (Actual)
- Primary completion
- Oct 2026 (Estimated)
- Completion
- Oct 2027 (Estimated)
- Last update posted
- Jan 29, 2026
2021 – 2027
United States locations
- U.S. sites
- 41
- U.S. states
- 21
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Physicians, Ironwood Cancer and Research Centers | Chandler | Arizona | 85224 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| University of California Irvine Medical Center | Orange | California | 92868 | — |
| Scripps Mercy Hospital | San Diego | California | 92111 | — |
| Providence Medical Foundation | Santa Rosa | California | 95403 | — |
| Stamford Hospital | Stamford | Connecticut | 06902 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33916-2233 | — |
| Cancer Specialists of North Florida -St Augustine | Saint Augustine | Florida | 32086 | — |
| Florida Cancer Specialists East | West Palm Beach | Florida | 33401 | — |
| Mission Cancer and Blood | Des Moines | Iowa | 50309 | — |
| Pikeville Medical Center, Inc. | Pikeville | Kentucky | 41501 | — |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | 20817 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| St. Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic | Rochester | Minnesota | 55905-0002 | — |
| Research Medical Center | Kansas City | Missouri | 64132 | — |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| The Mount Sinai Hospital | New York | New York | 10029 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Novant Cancer Institute Charlotte | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Regional Medical Oncology Center | Wilson | North Carolina | 27893 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45242 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| The James Cancer Hospital | Columbus | Ohio | 43210 | — |
| Oncology Associates of Bridgeport P.C. | Eugene | Oregon | 97401 | — |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | — |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | — |
| Tennessee Oncology PLLC | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| USO - Texas Oncology - San Antonio | San Antonio | Texas | 78240 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22908-0816 | — |
| Virginia Cancer Specialists, PC - Lee Highway | Fairfax | Virginia | 22031 | — |
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0070 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98104-2092 | — |
| Swedish Cancer Institute; STE 1020 | Seattle | Washington | 98104 | — |
| Northwest Cancer Specialists PC | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 135 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04965493, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 29, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04965493 live on ClinicalTrials.gov.