A Study to Evaluate the Safety and Efficacy of Tacabrutideg (BGB-16673) Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Tacabrutideg: Tacabrutideg will be administered orally
Pirtobrutinib: Pirtobrutinib will be administered orally
Study summary
The purpose of this study is to evaluate the efficacy and safety of tacabrutideg alone compared with pirtobrutinib in patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who had been previously treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi).
Eligibility
Primary outcome measure(s)
- Progression-Free Survival (PFS) per Independent Review Committee (IRC) — Up to approximately 3 years
PFS is defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for participants with chronic lymphocytic leukemia (CLL) and Lugano classification for participants with small lymphocytic lymphoma (SLL).
Trial sites (217)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama At Birmingham Hospital | Birmingham | Alabama | Recruiting |
| Mayo Clinic Phoenix | Phoenix | Arizona | Recruiting |
| Kaiser Permanente Southern California | Irvine | California | Recruiting |
| University of California San Diego (Ucsd) Moores Cancer Center | La Jolla | California | Recruiting |
| Cancer and Blood Specialty Clinic | Los Alamitos | California | Recruiting |
| UCLA Department of Medicine Hematologyoncology | Los Angeles | California | Recruiting |
| Kaiser Permanente Oakland Medical Center | Oakland | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| Kaiser Permanente Roseville Medical Center | Roseville | California | Recruiting |
| Kaiser Permanente San Francisco Medical Center Oncology | San Francisco | California | Recruiting |
| Kaiser Permanente Santa Clara Medical Center Oncologyhematology | Santa Clara | California | Recruiting |
| Kaiser Permanente Northern California | Vallejo | California | Recruiting |
| Kaiser Permanente Walnut Creek Medical Center | Walnut Creek | California | Recruiting |
| Christiana Care | Newark | Delaware | Recruiting |
| Medstar Georgetown University Hospital | Washington D.C. | District of Columbia | Recruiting |
| Mayo Clinic Jacksonville | Jacksonville | Florida | Recruiting |
| Cancer Specialists of North Florida | Jacksonville | Florida | Recruiting |
| Mount Sinai Medical Center Braman Comprehensive Cancer Center | Miami | Florida | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| Mission Cancer and Blood | Waukee | Iowa | Recruiting |
| The University of Kansas Cancer Center | Westwood | Kansas | Recruiting |
| Our Lady of the Lake Hospital | Baton Rouge | Louisiana | Recruiting |
| Mary Bird Perkins Cancer Center | Baton Rouge | Louisiana | Recruiting |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Recruiting |
| Dana Farber Cancer Institute | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| Titan Health Partners Llc Dba Astera Cancer Care | East Brunswick | New Jersey | Recruiting |
| John Theurer Cancer Center Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Columbia University Medical Center | New York | New York | Recruiting |
| Weill Cornell Medical College Newyork Presbyterian Hospital | New York | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center Mskcc | New York | New York | Recruiting |
| University of Rochester | Rochester | New York | Recruiting |
| University of North Carolina At Chapel Hill | Chapel Hill | North Carolina | Recruiting |
| Atrium Health Levine Cancer Institute (Lci) | Charlotte | North Carolina | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Atrium Health Wake Forest Baptist | Winston-Salem | North Carolina | Recruiting |
| Dayton Physician Network | Dayton | Ohio | Recruiting |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | Recruiting |
+ 177 more sites — see the full list on the official registry below.
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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 NCT06973187 on ClinicalTrials.gov ↗ ← All trials in Japan