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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pirtobrutinib: Oral Pirtobrutinib
Idelalisib: Oral
Bendamustine: IV
Rituximab: IV
Study summary
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.
Eligibility
Primary outcome measure(s)
- Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC) — Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)
PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.
Trial sites (232)
| Facility | City | Region | Status |
|---|---|---|---|
| Southern Cancer Center, P.C. | Daphne | Alabama | |
| Mitchell Cancer Institute -University of South Alabama | Mobile | Alabama | |
| Palo Verde Hematology Oncology | Glendale | Arizona | |
| Arizona Oncology Associates, P.C. - HOPE | Tucson | Arizona | |
| Orange Coast Memorial Medical Center | Fountain Valley | California | |
| California Research Institute | Los Angeles | California | |
| Rocky Mountain Cancer Center | Aurora | Colorado | |
| Medical Oncology Hematology Consultants, PA | Newark | Delaware | |
| Boca Raton Regional Hospital | Boca Raton | Florida | |
| Cancer Specialists of North Florida -St Augustine | Jacksonville | Florida | |
| Oncology-Hematology Associates of West Broward | Tamarac | Florida | |
| WellStar Health System | Marietta | Georgia | |
| Rush University Medical Center | Chicago | Illinois | |
| Illinois Cancer Specialists-Niles | Niles | Illinois | |
| Community Health Network | Indianapolis | Indiana | |
| Arnett Cancer Center | Lafayette | Indiana | |
| University of Kentucky Markey Cancer Center | Lexington | Kentucky | |
| Norton Cancer Institute | Louisville | Kentucky | |
| Mercy Health-Paducah Medical Oncology and Hematology | Paducah | Kentucky | |
| Cancer Center Office of Clinical Research | New Orleans | Louisiana | |
| Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | |
| Saint Joseph Mercy Hospital | Ann Arbor | Michigan | |
| Ascension St. John Hospital | Grosse Pointe Woods | Michigan | |
| Minnesota Oncology/Hematology PA | Saint Paul | Minnesota | |
| St. Vincent Frontier Cancer Center | Billings | Montana | |
| Nebraska Hematology-Oncology | Lincoln | Nebraska | |
| New Jersey Center for Cancer Research | Brick | New Jersey | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| University of Rochester | Rochester | New York | |
| Clinical Research Alliance, Inc. | Westbury | New York | |
| Oncology Hematology Care Inc | Cincinnati | Ohio | |
| Willamette Valley Cancer Institute and Research Center | Eugene | Oregon | |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | |
| Texas Oncology - Amarillo | Amarillo | Texas | |
| Texas Oncology Cancer Center | Austin | Texas | |
| Texas Oncology - Medical City Dallas | Dallas | Texas | |
| Texas Oncology - Dallas Presbyterian Hospital | Dallas | Texas | |
| Brooke Army Medical Center | Fort Sam Houston | Texas | |
| Texas Oncology Fort Worth | Fort Worth | Texas | |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas |
+ 192 more sites — see the full list on the official registry below.
On this site
📄 Rituxan (rituximab) drug profile →More Loxo Oncology, Inc. trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04666038 on ClinicalTrials.gov ↗ ← All trials in Italy