A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Condition(s) studied
Investigational drug(s) / intervention(s)
Pirtobrutinib: Administered orally.
Ibrutinib: Administered orally.
Study summary
The purpose of Part 1 of this study is to compare the efficacy and safety of pirtobruitinib (LOXO-305) to ibrutinib in participants with CLL/SLL; participants may or may not have already had treatment for their cancer. The purpose of Part 2 of this study evaluates pirtobrutinib monotherapy in treatment-naïve participants with CLL/SLL with 17p deletions. Participation could last up to six years for Part 1. Participation could last up to 2 years for Part 2.
Eligibility
Primary outcome measure(s)
- Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (Cri), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 1 — Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest] (approximately 3 years and 5 months)
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria - Percentage of Participants Achieving Complete Response (CR), Complete Remission with Incomplete Hematologic Recovery (CRi), Nodular Partial Remission (nPR) or Partial Response (PR): Overall Response Rate (ORR) Part 2 — Baseline to best overall response the best response recorded from Cycle 1 Day 1 until data cutoff date, PD, or start of new anticancer treatment, whichever is the earliest (Approximately 2 years and 3 months)
ORR as assessed by independent review committee (IRC) per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria
Trial sites (143)
| Facility | City | Region | Status |
|---|---|---|---|
| Pacific Cancer Medical Center, Inc | Anaheim | California | Recruiting |
| TOI Clinical Research | Cerritos | California | Recruiting |
| Stanford School of Medicine-Cancer Clinical Trials Office | Palo Alto | California | Recruiting |
| California Cancer Associates for Research and Excellence | San Marcos | California | Active Not Recruiting |
| Florida Cancer Specialists | Fort Myers | Florida | Recruiting |
| Cancer Specialists of North Florida -St Augustine | Saint Augustine | Florida | Recruiting |
| Florida Cancer Specialists East | West Palm Beach | Florida | Recruiting |
| Hematology Oncology Clinic | Baton Rouge | Louisiana | Active Not Recruiting |
| Tulane Cancer Center Office of Clinical Research | New Orleans | Louisiana | Active Not Recruiting |
| American Oncology Partners of Maryland, PA | Bethesda | Maryland | Recruiting |
| St. Vincent Frontier Cancer Center | Billings | Montana | Recruiting |
| Cancer Care Associates Of York | York | Pennsylvania | Active Not Recruiting |
| Prisma Health Cancer Institute | Greenville | South Carolina | Active Not Recruiting |
| Sarah Cannon Research Institute SCRI | Nashville | Tennessee | Recruiting |
| Kelsey Research Foundation | Houston | Texas | Active Not Recruiting |
| Lumi Research | Kingwood | Texas | Recruiting |
| Virginia Cancer Institute | Richmond | Virginia | Recruiting |
| Medical Oncology Associates, PS | Spokane | Washington | Recruiting |
| MultiCare Health System Institute for Research and Innovation | Spokane | Washington | Active Not Recruiting |
| Alexander Fleming | Ciudad Autónoma de Buenos Aire | Argentina | Recruiting |
| Hospital Privado De Comunidad | Mar del Plata | Argentina | Active Not Recruiting |
| Clínica de Nefrología, Urología y Enfermedades Cardiovasculares | Santa Fe | Argentina | Recruiting |
| One Clinical Research | Nedlands | Australia | Active Not Recruiting |
| Western Health, Sunshine Hospital | St Albans | Australia | Active Not Recruiting |
| The Perth Blood Institute | West Perth | Australia | Recruiting |
| Hanusch Krankenhaus | Vienna | Austria | Active Not Recruiting |
| Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | Recruiting |
| VITAZ | Sint-Niklaas | Belgium | Recruiting |
| Fundação Pio XII - Hospital de Câncer de Barretos | Barretos | Brazil | Recruiting |
| Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP | Botucatu | Brazil | Recruiting |
| Hemocentro Unicamp | Campinas | Brazil | Recruiting |
| Hospital Uopeccan - Centro de Pesquisa Clinica | Cascavel | Brazil | Recruiting |
| Centro Integrado de Oncologia de Curitiba | Curitiba | Brazil | Active Not Recruiting |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer | Curitiba | Brazil | Recruiting |
| Instituto do Câncer - Hospital São Vicente de Paulo | Passo Fundo | Brazil | Recruiting |
| Centro Gaucho Integrado - Mae de Deus Center | Porto Alegre | Brazil | Recruiting |
| Hospital de Clínicas de Ribeirão Preto | Ribeirão Preto | Brazil | Recruiting |
| CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia | Santo André | Brazil | Recruiting |
| Centro Integrado de Pesquisa Clinica | São José do Rio Preto | Brazil | Recruiting |
| Hospital BP | São Paulo | Brazil | Recruiting |
+ 103 more sites — see the full list on the official registry below.
On this site
📄 Imbruvica (ibrutinib) drug profile →More Loxo Oncology, Inc. trials in Japan
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 NCT05254743 on ClinicalTrials.gov ↗ ← All trials in Japan