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Clinical Trials in the UK / NCT04965493
Active, not recruiting Phase 3

A Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) Versus Venetoclax and Rituximab (VR) in Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

NCT04965493 · tracked via the Priya Life Science UK tracker
Sponsor
Loxo Oncology, Inc.
Phase
Phase 3
Started
2021-09-20
Last updated
2026-01-29

Condition(s) studied

Chronic Lymphocytic LeukemiaSmall Lymphocytic Lymphoma

Investigational drug(s) / intervention(s)

PirtobrutinibVenetoclaxRituximab

Pirtobrutinib: Oral

Venetoclax: Oral

Rituximab: Intravenous (IV)

Study summary

The purpose of this study is to compare the efficacy and safety of fixed duration pirtobruitinib (LOXO-305) with VR (Arm A) compared to VR alone (Arm B) in patients with CLL/SLL who have been previously treated with at least one prior line of therapy. Participation could last up to five years.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria * Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor * Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L * Adequate organ function * Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 * Estimated creatinine clearance ≥30 milliliters per minute (mL/min) Exclusion Criteria: * Known or suspected Richter's transformation at any time preceding enrollment * Prior therapy with a non-covalent (reversible) BTK inhibitor * Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist * Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers * Prior therapy with venetoclax * Central nervous system (CNS) involvement * Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection * Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count * Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days * Active hepatitis B or hepatitis C * Known active cytomegalovirus (CMV) infection * Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA) * Significant cardiovascular disease * Vaccination with a live vaccine within 28 days prior to randomization * Patients with the following hypersensitivity: * Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax * Prior significant hypersensitivity to rituximab * Known allergy to allopurinol and inability to take uric acid lowering agent

Primary outcome measure(s)

Trial sites (176)

FacilityCityRegionStatus
Ironwood Physicians, Ironwood Cancer and Research Centers Chandler Arizona
Mayo Clinic Hospital Phoenix Arizona
University of California Irvine Medical Center Orange California
Scripps Mercy Hospital San Diego California
Providence Medical Foundation Santa Rosa California
Stamford Hospital Stamford Connecticut
Florida Cancer Specialists Fort Myers Florida
Cancer Specialists of North Florida -St Augustine Saint Augustine Florida
Florida Cancer Specialists East West Palm Beach Florida
Mission Cancer and Blood Des Moines Iowa
Pikeville Medical Center, Inc. Pikeville Kentucky
American Oncology Partners of Maryland, PA Bethesda Maryland
Dana-Farber Cancer Institute Boston Massachusetts
St. Joseph Mercy Hospital Ann Arbor Michigan
University of Michigan Ann Arbor Michigan
Mayo Clinic Rochester Minnesota
Research Medical Center Kansas City Missouri
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey
The Mount Sinai Hospital New York New York
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Levine Cancer Institute Charlotte North Carolina
Novant Cancer Institute Charlotte Charlotte North Carolina
Duke University Medical Center Durham North Carolina
Regional Medical Oncology Center Wilson North Carolina
Oncology Hematology Care Inc Cincinnati Ohio
University Hospitals Cleveland Medical Center Cleveland Ohio
The James Cancer Hospital Columbus Ohio
Oncology Associates of Bridgeport P.C. Eugene Oregon
Fox Chase Cancer Center Philadelphia Pennsylvania
Sarah Cannon Research Institute SCRI Nashville Tennessee
Tennessee Oncology PLLC Nashville Tennessee
Texas Oncology-Baylor Charles A. Sammons Cancer Center Dallas Texas
University of Texas MD Anderson Cancer Center Houston Texas
USO - Texas Oncology - San Antonio San Antonio Texas
University of Virginia Health System Charlottesville Virginia
Virginia Cancer Specialists, PC - Lee Highway Fairfax Virginia
Virginia Commonwealth University Massey Cancer Center Richmond Virginia
Fred Hutchinson Cancer Research Center Seattle Washington
Swedish Cancer Institute; STE 1020 Seattle Washington

+ 136 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile → 📄 Rituxan (rituximab) drug profile →

More Loxo Oncology, Inc. trials in the UK

Other trials for the same condition

Official registry record

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 NCT04965493 on ClinicalTrials.gov ↗ ← All trials in the UK