Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Public ClinicalTrials.gov record NCT04666038. 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's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
Study identification
- NCT ID
- NCT04666038
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 238 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
- Mar 9, 2021 (Actual)
- Primary completion
- Aug 29, 2023 (Actual)
- Completion
- May 2027 (Estimated)
- Last update posted
- Apr 24, 2026
2021 – 2027
United States locations
- U.S. sites
- 46
- U.S. states
- 25
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern Cancer Center, P.C. | Daphne | Alabama | 36526 | — |
| Mitchell Cancer Institute -University of South Alabama | Mobile | Alabama | 36604 | — |
| Palo Verde Hematology Oncology | Glendale | Arizona | 85304 | — |
| Arizona Oncology Associates, P.C. - HOPE | Tucson | Arizona | 85711 | — |
| Orange Coast Memorial Medical Center | Fountain Valley | California | 92708 | — |
| California Research Institute | Los Angeles | California | 90027 | — |
| Rocky Mountain Cancer Center | Aurora | Colorado | 80012 | — |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | 19713 | — |
| Boca Raton Regional Hospital | Boca Raton | Florida | 33486 | — |
| Cancer Specialists of North Florida -St Augustine | Jacksonville | Florida | 32256 | — |
| Oncology-Hematology Associates of West Broward | Tamarac | Florida | 33321 | — |
| WellStar Health System | Marietta | Georgia | 30060 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| Illinois Cancer Specialists-Niles | Niles | Illinois | 60714 | — |
| Community Health Network | Indianapolis | Indiana | 46250 | — |
| Arnett Cancer Center | Lafayette | Indiana | 47904 | — |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | 40563 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Mercy Health-Paducah Medical Oncology and Hematology | Paducah | Kentucky | 42003 | — |
| Cancer Center Office of Clinical Research | New Orleans | Louisiana | 70112 | — |
| Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201 | — |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | 48106 | — |
| Ascension St. John Hospital | Grosse Pointe Woods | Michigan | 48236 | — |
| Minnesota Oncology/Hematology PA | Saint Paul | Minnesota | 55102 | — |
| St. Vincent Frontier Cancer Center | Billings | Montana | 59102 | — |
| Nebraska Hematology-Oncology | Lincoln | Nebraska | 68506 | — |
| New Jersey Center for Cancer Research | Brick | New Jersey | 08724 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10021 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Clinical Research Alliance, Inc. | Westbury | New York | 11590 | — |
| Oncology Hematology Care Inc | Cincinnati | Ohio | 45236 | — |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | 97401 | — |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | 29732 | — |
| Texas Oncology - Amarillo | Amarillo | Texas | 79106 | — |
| Texas Oncology Cancer Center | Austin | Texas | 78705 | — |
| Texas Oncology - Medical City Dallas | Dallas | Texas | 75230 | — |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | 75231 | — |
| Brooke Army Medical Center | Fort Sam Houston | Texas | 78234 | — |
| Texas Oncology Fort Worth | Fort Worth | Texas | 76104 | — |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Texas Oncology - McAllen | McAllen | Texas | 78503 | — |
| Texas Oncology - San Antonio Medical Center | San Antonio | Texas | 78240 | — |
| Virginia Cancer Specialists, PC | Gainesville | Virginia | 20155 | — |
| Oncology and Hematology Associates of Southwest Virginia Inc | Roanoke | Virginia | 24014 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
| University of Wisconsin Carbone Cancer Center | Madison | Wisconsin | 53705 | — |
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 186 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04666038, 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 Apr 24, 2026 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04666038 live on ClinicalTrials.gov.