Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)
Public ClinicalTrials.gov record NCT04662255. 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 LOXO-305 Versus Investigator Choice of BTK Inhibitor in Patients With Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study for participants with a type of blood cancer called mantle cell lymphoma (MCL). The main purpose is to compare pirtobrutinib (LOXO-305) to other drugs that work in a similar way that have already been approved by the United States Food and Drug Administration (US FDA). Participation could last up to two years, and possibly longer, if the disease does not progress.
Study identification
- NCT ID
- NCT04662255
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 500 participants
Conditions and interventions
Conditions
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
- Apr 8, 2021 (Actual)
- Primary completion
- Nov 2027 (Estimated)
- Completion
- Jun 2030 (Estimated)
- Last update posted
- Sep 23, 2026
2021 – 2030
United States locations
- U.S. sites
- 36
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alaska Oncology and Hematology, LLC | Anchorage | Alaska | 99508 | — |
| Arizona Oncology Associates, P.C. - HOPE | Phoenix | Arizona | 85013 | — |
| UCLA Medical Center | Los Angeles | California | 90095 | — |
| USO-Rocky Mountain Cancer Center | Denver | Colorado | 80218 | — |
| Mayo Clinic in Florida | Jacksonville | Florida | 32224 | — |
| Oncology-Hematology Associates of West Broward | Tamarac | Florida | 33321 | — |
| Florida Cancer Specialists East | West Palm Beach | Florida | 33401 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40504 | — |
| Mercy Health-Paducah Medical Oncology and Hematology | Paducah | Kentucky | 42003 | — |
| Tulane Cancer Center Office of Clinical Research | New Orleans | Louisiana | 70112 | — |
| Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| DFCI Lymphoma | Boston | Massachusetts | 02115 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Mayo Clinic | Rochester | Minnesota | 55905-0002 | — |
| Washington University Medical School | St Louis | Missouri | 63110 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Messino Cancer Center | Asheville | North Carolina | 28806 | — |
| Levine Cancer Institute | Charlotte | North Carolina | 28204 | — |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1045 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45219 | — |
| Willamette Valley Cancer Institute & Research Ctr. | Eugene | Oregon | 97401 | — |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Austin Midtown | Austin | Texas | 78705 | — |
| Texas Oncology - Bedford | Bedford | Texas | 76022 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Texas Oncology - McAllen | McAllen | Texas | 78503 | — |
| Texas Oncology - Sherman | Sherman | Texas | 75090 | — |
| US Oncology | The Woodlands | Texas | 77380 | — |
| Texas Oncology - Tyler | Tyler | Texas | 75702 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | — |
| USO-Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705-2254 | — |
| Froedtert Memorial Lutheran Hospital | Milwaukee | Wisconsin | 53226 | — |
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 153 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04662255, 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 Sep 23, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04662255 live on ClinicalTrials.gov.