A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Condition(s) studied
Study summary
The main purpose of Part 1 of this study is to assess the efficacy and safety of 3 dose levels of Pirtobrutinib in participants with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), who have received 1-3 lines of treatment including a covalent Bruton tyrosine kinase (BTK) inhibitor. The purpose of Part 2 of this study is to evaluate pirtobrutinib monotherapy in participants with treatment-naïve CLL/SLL with 17p deletions. Participation in Part 1 is expected to last approximately 3 years. Participation in Part 2 is expected to last up to 2 years.
Eligibility
Primary outcome measure(s)
- Overall Response Rate — Baseline up to 3 years
Overall response rate is defined as the proportion of participants who achieve the best overall response at or before the initiation of subsequent anticancer therapy of CR, CRi, nPR, or PR. ORR will be assessed using International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 response criteria.
Trial sites (131)
| Facility | City | Region | Status |
|---|---|---|---|
| Ironwood Cancer & Research Centers | Chandler | Arizona | Recruiting |
| City of Hope National Medical Center | Duarte | California | Recruiting |
| City of Hope National Medical Center | Irvine | California | Recruiting |
| Palo Alto Medical Foundation Research Institute (PAMFRI) | Palo Alto | California | Recruiting |
| Stanford Cancer Center | Palo Alto | California | Recruiting |
| Rocky Mountain Cancer Center | Aurora | Colorado | Recruiting |
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Miami | Florida | Recruiting |
| City of Hope National Medical Center, Atlanta Cancer Center | Newnan | Georgia | Recruiting |
| Mission Cancer + Blood | Waukee | Iowa | Recruiting |
| Saint Elizabeth Medical Center Edgewood | Edgewood | Kentucky | Recruiting |
| American Oncology Partners, PA | Bethesda | Maryland | Recruiting |
| Boston Medical Center | Boston | Massachusetts | Recruiting |
| Gulfport Memorial Hospital | Gulfport | Mississippi | Recruiting |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | Recruiting |
| East Carolina University | Greenville | North Carolina | Recruiting |
| Williamette Valley Cancer Institute & Research Center | Eugene | Oregon | Recruiting |
| Cancer Care Associates Of York | York | Pennsylvania | Recruiting |
| The West Clinic, PLLC dba West Cancer Center | Germantown | Tennessee | Recruiting |
| USO-Texas Oncology-Central/South Texas | Austin | Texas | Recruiting |
| Sarah Cannon Research Institute/SCRI | The Woodlands | Texas | Recruiting |
| USO-Virginia Oncology Associates | Hampton | Virginia | Recruiting |
| Flinders Medical Centre | Adelaide | Australia | Recruiting |
| Bankstown-Lidcombe Hospital | Bankstown | Australia | Recruiting |
| Box Hill Hospital | Box Hill | Australia | Recruiting |
| Coffs Harbour Health Campus | Coffs Harbour | Australia | Recruiting |
| Royal Hobart Hospital | Hobart | Australia | Recruiting |
| ICON Cancer Centre - Kurralta Park | Kurralta Park | Australia | Recruiting |
| Latrobe Regional Health | Traralgon | Australia | Recruiting |
| Calvary Mater Newcastle | Waratah | Australia | Recruiting |
| The Perth Blood Institute - West Perth | West Perth | Australia | Recruiting |
| Princess Alexandra Hospital | Woolloongabba | Australia | Recruiting |
| Institut Jules Bordet | Anderlecht | Belgium | Recruiting |
| AZ Sint-Jan Brugge-Oostende AV | Bruges | Belgium | Recruiting |
| UZ Gent | Ghent | Belgium | Recruiting |
| Groupe Jolimont | La Louvière | Belgium | Recruiting |
| UZ Leuven | Leuven | Belgium | Recruiting |
| Clinique Saint Pierre | Ottignies | Belgium | Recruiting |
| AZ Delta vzw | Roeselare | Belgium | Recruiting |
| AZ Nikolaas | Sint-Niklaas | Belgium | Recruiting |
| CHR Verviers - La Tourelle | Verviers | Belgium | Recruiting |
+ 91 more sites — see the full list on the official registry below.
More Loxo Oncology, Inc. trials in Denmark
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 NCT06588478 on ClinicalTrials.gov ↗ ← All trials in Denmark